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Contraindications and Cautions for MediHerb Botanicals Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes . Astragalus Complex Ginkgo 2000mg Bacopa Complex Golden Seal 500mg Bilberry 6000mg Gotu Kola Complex Boswellia Complex Gut Flora Complex Gymnema 4g Broncafect ® Broncafect Phytosynergist ® Hawthorn Burdock Complex Herbal Throat Spray Phytosynergist® Capsella Complex Phytosynergist® HiPep Cat’s Claw Complex Horsechestnut Complex Chaste Tree LivCo® ChelaCo Livton® Complex Colax Nevaton® Coleus Forte ProstaCo Cramplex PulmaCo Cranberry Complex Rehmannia Complex DermaCo ResCo® DiaCo Phytosynergist® ResCo Phytosynergist® DiGest Rhodiola & Ginseng Complex DiGest Phytosynergist ® Saligesic Dong Quai Silymarin Echinacea Premium St John’s Wort 1.8g Eleuthero Thyroid Complex Euphrasia Complex Tribulus Evening Primrose Oil UriCo Phytosynergist® Fe-Max Iron Tonic Phytosynergist® Valerian Complex Feverfew Vitanox® Ganoderma & Shiitake Wild Yam Complex Garlic 5000mg Withania Complex Wormwood Complex 3 Contraindications and Cautions Liquid Extracts Albizia 1:2 Gotu Kola 1:1 Ashwaganda 1:1 Gymnema 1:1 Astragalus 1:2 Hawthorn Berries 1:2 Bacopa 1:2 Horsechestnut 1:2 Bilberry 1:1 Horsetail 1:2 Black Cohosh 1:2 Korean Ginseng 1:2 Black Walnut Hulls 1:10 Licorice 1:1 Bladderwrack 1:1 Licorice High Grade 1:1 Bugleweed 1:2 Marshmallow Root 1:5 Glycetract Bupleurum 1:2 Milk Thistle 1:1 Burdock 1:2 Milk Thistle 1:1 Glycetract Calendula 1:2 Mistletoe 1:2 Californian Poppy 1:2 Motherwort 1:2 Cat’s Claw 1:2 Nettle Leaf 1:2 Celery Seed 1:2 Nettle Root 1:2 Chamomile High Grade 1:2 Oats Seed 1:1 Chaste Tree 1:2 Oregon Grape 1:2 Chinese Skullcap 1:2 Pau d’Arco 1:2 Cinnamon Quills 1:2 Poke Root 1:5 Cleavers 1:2 Red Clover 1:2 Coleus 1:1 Rehmannia 1:2 Corn Silk 1:1 Sage 1:2 Cramp Bark 1:2 Sarsaparilla 1:2 Damiana 1:2 Saw Palmetto 1:2 Dandelion Leaves 1:1 Schisandra 1:2 Dandelion Root 1:2 Skullcap 1:2 Dong Quai 1:2 St John’s Wort 1:2 Echinacea Premium Blend 1:2 St John’s Wort High Grade 1:2 Echinacea Purpurea 1:2 Tienchi Ginseng 1:2 Echinacea Purpurea 1:3 Glycetract Turmeric 1:1 Eleuthero 1:2 Uva Ursi 1:2 Eyebright 1:2 Valerian 1:2 Garlic 1:1 White Peony 1:2 Ginger 1:2 Wild Yam 1:2 Ginkgo 2:1 Wormwood 1:5 Globe Artichoke 1:2 Yellow Dock 1:2 Golden Seal 1:3 4 Contraindications and Cautions Introduction This volume of contraindication and drug interaction information has been compiled by MediHerb® and Standard Process® as a resource for health care professionals who recommend MediHerb herbal products distributed by Standard Process. In this volume, MediHerb and Standard Process have brought together herb-specific information regarding cautions, potential adverse reactions and interactions with drugs. It is presented in summary form and is drawn from widely used, authoritative herbal references. The reader should recognize, however, that the information presented has not been confirmed or agreed to by MediHerb or Standard Process. For example, some information is based on in vitro data which has not been substantiated by clinical studies. To provide basic information on contraindications and drug interactions, MediHerb and Standard Process referred to fifteen English language reference texts that are used in the United States and worldwide. This compilation of information and references is presented for the convenience of health care professionals who are encouraged to review the source literature directly. This volume should not be understood to be either complete or final. Information on herbs for health, like information on other pharmacologically active compounds, is evolutionary. Health care professionals should be alert to new information and should use reasonably available research materials to keep up-to-date. Readers are also advised that the information presented in this volume covers herbs and essential oils (and not vitamins or minerals). How to Use this Publication The information is laid out in order of product name and by category starting with Tablets, Capsules and Phytosynergist® Liquid Complexes and followed by Liquid Extracts. A general caution appears after the product name. Below this, detailed information for each ingredient (herb and essential oil) is presented. Example: If looking for information on Albizia Complex, go to the Tablets, Capsules and Phytosynergist® Liquid Complexes category. The general caution is indicated with the product name. Below this each of the component herbs in Albizia Complex (Chinese Skullcap, Albizia and Feverfew) are listed with the corresponding information provided from the reference texts. For ease of use the ingredients are listed in descending order with the ingredient of highest amount first. This presentation is consistent with the catalog and product label. Reference Text Information Adverse Effects of Herbal Drugs (AEHD),1,2,3 volumes 1, 2 & 3 are P.A.G.M. DeSmet’s effort as Managing Editor to draw together information gathered from available herbal pharmacovigilance sources, recognizing as well that the long history of traditional use of herbal medicines provide “a powerful tool, of course, for the identification of adverse effects.” These books were relied upon by the American Herbal Products Association in compiling the Botanical Safety Handbook, described below. The British Herbal Compendium (BHC)4 is a handbook of scientific information on widely used plant drugs edited by Peter R. Bradley. Each volume is a companion to the corresponding volume of the British Herbal Pharmacopoeia. The BHC is published by the Scientific Committee of the British Herbal Medicine Association. The basic approach of the BHC is to bring together scientific information from a variety of sources to produce clear and concise summaries on important aspects of individual plant drugs. The Botanical Safety Handbook (BSH)5 was published in 1997 by the American Herbal Products Association, the trade association of the herbal supplement industry in the United States. It’s authors include Association President Michael McGuffin and the President and Chief Executive Officer of the American Herbal Pharmacopoeia, Roy Upton. The preface to the BSH succinctly states its goal: The goal of the present work is to find a rational platform for the evaluation of herb safety, neither assuming that all natural substances are inherently safe, as some popular references suggest, nor blindly accepting reports of toxicity from uncritical sources. In undertaking this task the Editors met with information that presented significant challenges. Many authors utilize unreferenced data, perpetuate historical inaccuracies or display inherent biases against the use of botanicals. Also, contemporary reviews of the toxicity of many herbs are not available. Nonetheless, the Editors are confident that the body of information presented here is largely accurate. It is our sincere hope that readers of this work will find it to be a valuable reference and will address all useful criticisms to our attention. MediHerb’s Co-Founder, Kerry Bone, authored Clinical Applications of Ayurvedic and Chinese Herbs (CAACH)6 in October 1996 for the reason set forth in the subtitle, as Monographs for the Western Herbal Practitioner. In his preface, Kerry Bone underscores the importance of looking to traditional sources for guidance: As the pharmacological and clinical information on exotic plants accumulates, largely funded by the governments of India and China, western phytotherapists face an important decision. Do they ignore this useful information, or do they attempt to incorporate these plants into their daily practice? However, there is no need for any soul-searching since a traditional precedent already exists. The western system has continually adopted herbs from exotic locations. As global communication reaches new heights, and the stresses of ever-increasing industrialization create diseases common to all countries, modern phytotherapy must rise to the challenge. One aspect of meeting this challenge is the use of effective herbs, whatever their country of origin. 5 Contraindications and Cautions The European Scientific Cooperation of Phytotherapy (ESCOP) first published monographs on the medicinal uses of plant drugs in March 1996 in loose-leaf form as a series of fascicules. In 2003 the ESCOP monographs were completely revised and expanded and made available as a book.7 ESCOP is the European umbrella organization of national associations of phytotherapy. Members include the trade associations from the major European Union countries. The ESCOP Scientific Committee prepares the monograph as follows: In preparing drafts, [the] ESCOP Scientific Committee has the advantage that it can incorporate the views, knowledge and experience, not only of different nationalities, but also of individuals from different scientific and professional backgrounds, such as medical doctors, practicing phytotherapists, pharmacognosists, pharmacologists and regulatory affairs specialists. The Committee, operating as two subcommittees, assesses information from published scientific literature on each plant drug with the assistance of leading researchers on specific plants, who are invited to meetings of the Committee for discussion and critical evaluation of the literature. One of the strengths of Essential Oil Safety: A Guide for Health Care Professionals (EOS)8 is the presentation of concise profiles of essential oils. This includes safety information for the oral use of essential oils – an area of traditional practice often ignored. The book provides information from a number of scientific sources, including toxicological reports, in a transparent and reliable way. The function of the book, as described by the authors, is to reassure users of essential oils by showing that many supposed dangers do not in fact exist and also to “to hoist some red flags” where appropriate. The Therapeutic Guide to Herbal Medicine (TGHM),9 the Complete German Commission E Monographs, was published in 1998 by the American Botanical Council, a non-profit organization dedicated to providing scientific information about botanicals. This volume translates the Commission E monographs, the only substantial governmental review of herbal products. These monographs were published in the 1980s and early 1990s. The Commission has since disbanded. Accordingly, some of the work of the Commission is no longer generally accepted as current. Nonetheless, the Commission’s work has substantial value to health care professionals. The compiler of the translations, Mark Blumenthal, is founder and Executive Director of the American Botanical Council and is widely respected as an herbal expert. In his foreword to this volume, Varro E. Tyler, Ph.D., Sc.D., Dean and Distinguished Professor of Pharmacognosy Emeritus, Purdue University stated: . . . in 1978, the Bundesgesundheitsamt (Federal Health Agency), now called the Federal Institute for Drugs and Medical Devices, established an expert committee on herbal remedies, composed principally of members proposed by associations of the health professions, to evaluate the safety and efficacy of phytomedicines. This so-called “Commission E” included physicians, pharmacists, pharmacologists, toxicologists, representatives of the pharmaceutical industry, and lay persons. Its assessment is independent of the Federal Health Agency, which handles only the organizational details. Unlike the United States Food and Drug Administration which evaluates drugs only in a passive manner based on data supplied by the manufacturer, Commission E actively checks so-called bibliographic data independently. Such data include information obtained from clinical trials, field studies, collections of single cases, scientific literature including facts published in the standard reference works, and expertise of medical associations. If controlled clinical data are lacking, safety and efficacy can still be determined on the basis of information in the literature, the presence of supplemental data supporting clinical results, and significant experimental studies supporting traditional use. By 1993, about 300 such monographs had been prepared. Approximately two-thirds of them are positive assessments covering herbs that have been found to be safe and effective; the remainder are negative (unapproved), usually because use of the drug presents an unsatisfactory risk-benefit ratio. Although critical scientists and clinicians might quibble with a few of the findings in some of the monographs – I do so myself – it is necessary to remember that, taken as a whole, they represent the most accurate information available in the entire world on the safety and efficacy of herbs and phytomedicines. As such, they are worthy of careful study by anyone interested in any type of drug therapy. Ignorance of the Commission E monographs is ignorance of a substantial segment of modern medicine. Herbal Medicine (HM)10 is another book by Mark Blumenthal and his colleagues. It presents herbal information that expands on the German Commission E monographs. Published in 2000, this volume is one of the few up-to-date publications available in the field. Each herbal monograph is extensively annotated and referenced. Dr. Varro Tyler’s foreword to his volume articulated why this expanded text provides value to the field. Although the pioneering judgments rendered by the Commission E on the safety and efficacy of over 380 herbs remain generally the best available, there is, of course, always room for improvement. The medicinal potential of herbs has become the focus of more and more scientific and clinical studies in the field in recent years. New information has provided additional insights and, in some cases, modified previous judgments. That is only to be expected in such a dynamic field. Therefore, Mark Blumenthal, Alicia Goldberg, and Josef Brinckmann have performed a substantial service to all those interested in herbal medicine by expanding the content in the Commission E herb monographs of the most widely used herbs in America to include updated, detailed information on their botany, history, composition, safety, efficacy, and therapeutic use. And for those who lamented its initial absence, an extensive list of published references is provided, each of which is appropriately keyed to a specific statement in the monograph. This listing is followed by a compilation of additional literature resources for those who want still more background information on a particular botanical. In short, these expanded versions of selected original Commission E monographs would seem to fulfill all of the desires of those who felt that the original version did not meet their expectations, or that its large size and price did not allow for its widest distribution and use. I am quite certain that this volume will meet and even exceed those expectations and wishes. It is destined to occupy a prominent position on the shelf of useful herbal literature for the foreseeable future. 6 Contraindications and Cautions Principles and Practice of Phytotherapy (PPP)11 was coauthored by Simon Mills, Director, Centre for Complementary Health Studies, University of Exeter, UK, and Secretary of the Board of Directors of ESCOP together with MediHerb’s Kerry Bone. Simon Mills also serves as Chairman of the British Herbal Medicine Association. In his foreword, the highly respected American herbal scientist James A. Duke describes the Mills and Bone volume as follows: These authors, representing respectively the traditions of Great Britain and Australia, have 40 years of clinical practice of herbal medicine between them. They are also both solid scientists; able to apply rigorous scrutiny to the many claims made for their medicines. Every traditional claim offered forth in their book is countered by an exhaustive pharmacological and phytochemical analysis. And excitingly new, the authors have comprehensively covered, and covered well: herbal pharmacodynamics (effect of an active phytochemical at target site(s)) and pharmacokinetics, explaining what actually happens to the phytochemicals in the body when humans consume herbal medicines, and how much of a phytochemical can be concentrated at the site. It is most exciting to read what the authors have to say in this important and understudied area of herbal medicine. These pharmacokinetic observations alone would make the book worthwhile. Pharmacist Melanie Johns Cupp of West Virginia University is the editor of Toxicology and Clinical Pharmacology of Herbal Products (TCPHP).12 In this volume, the authors seek to provide “medical examiners, toxicologists, and health care providers with an objective review of the available information on the pharmacology and toxicology of commonly used herbs.” They present data from case reports and include information of value to pathologists. Human, animal and in vitro data are also presented along with information on pharmacology, therapeutics, and adverse effects. According to the author of the foreword, Steven B. Karch, M.D., they have done an “excellent job in combining the scientific literature for reliable, peer-reviewed information about the most widely used herbal products.” The World Health Organization‘s Monographs on Selected Medicinal Plants (WHO) were first published in 1999 to promote international harmonization in the quality control and use of herbal medicines and in the development of national formularies. Twenty-eight monographs were published in volume 1, with another series published in 2001.13,14 The second part of each monograph describes the clinical applications of the plant material, including detailed pharmacological information, contraindications, adverse effects and dosage. One of the most recent additions to the scholarship of herbal therapy is A Clinical Guide to Blending Liquid Herbs (CGBLH)15 written by MediHerb’s Kerry Bone and published in 2003 focuses solely on liquid herbal preparations and features monographs of 125 popular herbs. The monographs are written in an easy-to-read and summarized format presenting safety and clinical information relevant to the health care professional. Additional pharmacological and clinical information is provided for further study. In addition to the monographs, a chapter is devoted to explaining the principles of formulating liquid herbal mixtures for the individual patient, with examples for key conditions presented. Simon Mills notes in the foreword that “[Kerry] combines many years of herbal research and a personal commitment to producing the highest-quality herbal remedies with an equal experience in the consulting room with real patients. With this combination of skills, he has produced the most important guide to herbal prescription so far.” MediHerb and Standard Process encourage health care professionals to obtain these and other publications which describe the uses and cautions associated with the use of herbs for health. As herbs grow in popularity, more sources of information will appear. Health care professionals have an obligation to keep up-to-date on the growing literature of herbs for health in order to serve the needs of their patients. In particular The Essential Guide to Herbal Safety by Kerry Bone and Simon Mills should be consulted. This accurate and comprehensive book presents an extensive discussion of the principles of herbal safety and major issues relating to this important area. Leading international experts contribute to the book providing a wealth of information on issues such as quality, interactions, adverse reactions, toxicity, allergy, contact sensitivity and idiosyncratic reactions. The Essential Guide to Herbal Safety was the recipient of the American Botanical Council (ABC) James A. Duke Botanical Literature Award 2006, which honors the singular outstanding contribution by a book to the knowledge and understanding of medicinal and aromatic plants. NOTE: The information compiled in this volume is only as current as the references set forth above. For the most current scientific information regarding any of the herbs used in MediHerb products, the following online databases are updated on a regular basis and can be searched by herb name: http://ods.od.nih.gov/health.aspx National Institutes of Health Office of Dietary Supplements International Bibliographic Information on Dietary Supplements (IBIDS) database. http://www.ncbi.nlm.nih.gov/sites/entrez National Library of Medicine Medline database. http://www.herbmed.org Alternative Medicine Foundation. http://www.mediherb.com MediHerb Pty Ltd. REFERENCES 1 de Smet PAGM, Keller K, Hansel R et al (eds). Adverse Effects of Herbal Drugs, Volume 1. Springer-Verlag, Berlin, 1992. 2 de Smet PAGM, Keller K, Hansel R et al (eds). Adverse Effects of Herbal Drugs, Volume 2. Springer-Verlag, Berlin, 1993. 3 de Smet PAGM, Keller K, Hansel R et al (eds). Adverse Effects of Herbal Drugs, Volume 3. Springer-Verlag, Berlin, 1997. 4 British Herbal Medicine Association. British Herbal Compendium, Volume 1. BHMA, Bournemouth, 1992. 5 McGuffin M, Hobbs C, Upton R et al (eds). American Herbal Products Association’s Botanical Safety Handbook. CRC Press, Boca Raton, 1997. 6 Bone K. Clinical Applications of Ayurvedic and Chinese Herbs. Phytotherapy Press, Warwick, 1996. 7 ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd Edition. ESCOP, European Scientific Cooperative on Phytotherapy, Exeter, 2003. 8 Tisserand R, Balacs T. Essential Oil Safety: A Guide for Health Care Professionals. Churchill Livingstone, Edinburgh, 1995. 9 Blumenthal M et al (eds). The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. American Botanical Council, Austin, 1998. 10 Blumenthal M et al (eds). Herbal Medicine: Expanded Commission E Monographs. American Botanical Council, Austin, 2000. 11 Mills S, Bone K. Principles and Practice of Phytotherapy: Modern Herbal Medicine. Churchill Livingstone, Edinburgh, 2000. 12 Cupp MJ (ed). Toxicology and Clinical Pharmacology of Herbal Products. Humana Press, Totowa, NJ, 2000. 13 World Health Organization. WHO Monographs on Selected Medicinal Plants, Volume 1. WHO, Geneva, 1999. 14 World Health Organization. WHO Monographs on Selected Medicinal Plants, Volume 2. WHO, Geneva, 2001. 15 Bone K. A Clinical Guide to Blending Liquid Herbs: Herbal Formulations for the Individual Patient. Churchill Livingstone, St. Louis, 2003. 7 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Albizia Complex Contraindicated in individuals with a known hypersensitivity to Feverfew, parthenolide or other members of the daisy family. Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Chinese Skullcap Scutellaria baicalensis root 1 Albizia Albizia lebbek bark No information. None known. (CAACH, 94) Since the herb contains saponins, it may be a gastrointestinal irritant. It may also be contraindicated or at least inappropriate in topical application to open wounds, patients with celiac disease, and some upper digestive irritations. (PPP, 46, 170) None known. (CAACH, 95; CGBLH, 59) Feverfew Tanacetum parthenium leaf & stem 2b None known. (ESCOPM, 493; PPP, 391; CGBLH, 219) In vitro studies suggest that feverfew may inhibit platelet aggregation (TCPHP, 102), however, results from clinical trials suggest that normal clotting mechanisms remain intact. (PPP, 387) Traditionally contraindicated in cold conditions. (CGBLH, 83) Gastric discomfort occurs rarely. (AEHD2, 291) Contraindication: pregnancy. Occasional mouth ulceration and gastric disturbances have been reported, but the incidence is low. Contact allergy is known but rare. No major adverse effects with long-term use have been recorded. (BHC, 97) Contraindicated in those with known hypersensitivity to either feverfew, parthenolide or other members of the Compositae family. (PPP, 391; WHO2, 324; CGBLH, 219) None known. (CGBLH, 83) Andrographis Complex Contraindicated in pregnancy and lactation. Contraindicated in known allergy to plants of the daisy family. Echinacea Echinacea angustifolia root 1 Commission E cautioned that Echinacea pallida root and E. angustifolia herb and root should not be used in systemic diseases such as tuberculosis, leukosis, collagenosis, multiple sclerosis, AIDS, HIV infections, and other autoimmune diseases (based on theoretical considerations and not on any reports of adverse findings). Other authoritative sources do not support these restrictions. (HM, 94; TGHM, 121, 328; PPP, 359-360) Allergic reactions, mainly contact dermatitis, may occur rarely in susceptible patients from Echinacea aerial parts. The likelihood of Echinacea root preparations causing allergy is very low. (CGBLH, 185) None known. (HM, 95; PPP, 360) Caution is advised for transplant patients taking immunosuppressive drugs, short-term therapy only is suggested. (PPP, 360; CGBLH, 185) Refer to the MediHerb Herb-Drug Interactions chart. Holy Basil Ocimum tenuiflorum leaf No information. Contraindicated during pregnancy and lactation. (WHO2, No information. 212) Andrographis Andrographis paniculata herb 2b Holy Basil Ocimum tenuiflorum leaf essential oil No information. No information. Note: Contraindication: pregnancy, (BSH, 9; CAACH, 100; CGBLH, 65) lactation; known allergy to plants of the Acanthaceae family. (WHO2, 20) High doses may cause gastric discomfort, loss of appetite and vomiting, but generally there are few side effects and it is non-toxic. (CAACH, 99) Two cases of urticaria have been reported. (WHO2, 21; CGBLH, 65) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 None known. (PPP, 266; CGBLH, 65) No information. The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 8 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Astragalus Complex Contraindicated in known allergy to plants of the daisy family. Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Discontinue during an acute infection or fever. Astragalus Astragalus membranaceus root 1 Contraindications: not advisable in acute infections. (PPP, None known. (PPP, 277; WHO1, 56; BSH, 17; CGBLH, 277; CAACH, 19; CGBLH, 77) 77) Echinacea Echinacea purpurea root 1 Commission E cautioned that Echinacea pallida root should not be used in systemic diseases such as tuberculosis, leukosis, collagenosis, multiple sclerosis, AIDS, HIV infections, and other autoimmune diseases (based on theoretical considerations and not on any reports of adverse findings). Other authoritative sources do not support these restrictions. (TGHM, 121; PPP, 359-360) Should not be administered to patients with known allergy to any plant of Asteraceae (Compositae). (ESCOPM, 137) Allergic reactions, mainly contact dermatitis, may occur rarely in susceptible patients from Echinacea aerial parts. The likelihood of Echinacea root preparations causing allergy is very low. (CGBLH, 185) None known. (ESCOPM, 137; PPP, 360) Caution is advised for transplant patients taking immunosuppressive drugs, short-term therapy only is suggested. (PPP, 360; CGBLH, 185) Contraindicated in acute phase of infections, (PPP, 142, 539) pregnancy, lactation and in cases of known allergy to plants of the Araliaceae family. (WHO2, 91) Commission E noted a contraindication for hypertension. (HM, 107; PPP, 539; TGHM, 125) Two clinical studies recommend that Eleutherococcus not be administered to patients with high blood pressure (HM, 107; TGHM, 62; BSH, 45), although a causal relationship to the use of Eleutherococcus could not be established. (ESCOPM, 142) Caution is advised in cardiovascular disorders. (CGBLH, 195) Insomnia, palpitations, tachycardia and hypertension have been rarely observed in association with clinical studies. (BSH, 45; CGBLH, 195) None known. (HM, 108; TGHM, 125; PPP, 539; ESCOPM, 143) Reports that the herb may increase serum digoxin levels, but not conclusive (PPP, 539) and the identity of the plant material as Eleutherococcus was not established. (WHO2, 91) Eleuthero Eleutherococcus senticosus root Note: 1 The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 Refer to the MediHerb Herb-Drug Interactions chart. Refer to the MediHerb Herb-Drug Interactions chart. The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 9 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Bacopa Complex Contraindicated in pregnancy. Contraindicated during lactation unless otherwise directed by a qualified health care professional. Discontinue during an acute infection or fever. Schisandra Schisandra chinensis fruit 1 Contraindicated in pregnancy, except to assist childbirth; in the early stages of cough or rash and in excess heat patterns. (CGBLH, 405) May be contraindicated in liver carcinoma. (PPP, 192) Rare side effects of appetite suppression, stomach upset, and urticaria are reported. (BSH, 104) None known. (CGBLH, 405) Refer to the MediHerb Herb-Drug Interactions chart. Bacopa Bacopa monnieri herb No information. Containing saponins, this herb is a potential gastrointestinal irritant. (PPP, 46; CGBLH, 80) None known. (CAACH, 101-102; CGBLH, 80) Eleuthero Eleutherococcus senticosus root 1 None known. (HM, 108; TGHM, 125; PPP, 539; ESCOPM, 143) Reports that the herb may increase serum digoxin levels, but not conclusive (PPP, 539) and the identity of the plant material as Eleutherococcus was not established. (WHO2, 91) Contraindicated in acute phase of infections, (PPP, 142, 539) pregnancy, lactation and in cases of known allergy to plants of the Araliaceae family. (WHO2, 91) Commission E noted a contraindication for hypertension. (HM, 107; PPP, 539; TGHM, 125) Two clinical studies recommend that Eleutherococcus not be administered to patients with high blood pressure (HM, 107; TGHM, 62; BSH, 45), although a causal relationship to the use of Eleutherococcus could not be established. (ESCOPM, 142) Caution is advised in cardiovascular disorders. (CGBLH, 195) Insomnia, palpitations, tachycardia and hypertension have been rarely observed in association with clinical studies. (BSH, 45; CGBLH, 195) Refer to the MediHerb Herb-Drug Interactions chart. Rosemary No information. No information. Adverse reactions are not noted for the daily dosage of 10–20 drops. (TGHM, 48, 197) Based on the cineole Rosmarinus officinalis leaf essential oil content of the essential oil, caution may be warranted in women wishing to conceive. (CGBLH, 389) At an oral daily dose of 0.5 mL or above: should not be taken in pregnancy; use with caution in epilepsy and fever. (EOS, 113-114, 165) Bilberry 6000mg Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Bilberry Vaccinium myrtillus fruit Note: 1 Very high doses should be used cautiously in patients with hemorrhagic disorders and in those taking warfarin or antiplatelet drugs. (PPP, 301) Mild side effects affecting the gastrointestinal, cutaneous and nervous systems observed in a small percentage of patients. (CGBLH, 93) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 None known. (HM, 18; TGHM, 88; ESCOPM, 346) Possible interaction with warfarin and antiplatelet drugs in very high doses. (PPP, 301) Refer to the MediHerb Herb-Drug Interactions chart. The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 10 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Boswellia Complex Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Boswellia Boswellia serrata gum oleoresin 1 No information. Celery Seed Apium graveolens fruit 2b, 2d None known. (CGBLH, 134) Apium graveolens can cause rare allergic reactions, even ending in anaphylactic shock ('celery-carrotmugwort' allergic reaction). (TGHM, 320; BHC, 57) Refer to the MediHerb Herb-Drug Interactions chart. Can contain phototoxic furanocoumarins. (TGHM, 320) The BHC recommends that celery is contraindicated in kidney disorders and pregnancy, (BHC, 57) although no evidence has been found for the contraindication in pregnancy. (CGBLH, 134) As a diuretic, inappropriate and possibly contraindicated in renal failure and diabetes. (PPP, 222; BSH, 11) Ginger Zingiber officinale rhizome 2b, 2d Contraindicated with gallstones; consult a physician first. (HM, 156; BSH, 125; TGHM, 136) May increase the chance of bleeding. (PPP, 401) A daily dose of 2 g of dried ginger should not be exceeded in pregnancy. Use with caution in cases of peptic ulceration, gastroesophageal reflux, or other gastric diseases. At doses approaching or greater than the maximum recommended dose, an increase in gastric secretory activity leading to heartburn is possible. (CGBLH, 227) Overdose may lead to a blood-thinning effect and an increase in gastric secretory activity leading to heartburn. (PPP, 401; ESCOPM, 548) Topical application may cause contact dermatitis in sensitive patients. (PPP, 401) None known. (HM, 156; TGHM, 136) May increase the absorption of pharmaceutical drugs. (PPP, 401) Caution indicated for daily doses of (dried) ginger in excess of 4 g with patients taking blood-thinning drugs such as warfarin, or aspirin or who have increased risk of hemorrhage. (PPP, 401; TCPHP, 129; CAACH, 106; CGBLH, 227) May enhance absorption of sulphaguanidine. (ESCOPM, 548) Contraindicated in obstruction of bile passages; in case of gallstones, use only after consulting with a physician. (TGHM, 222; HM, 382; WHO1, 121; PPP, 578; ESCOPM, 107) The herb should not be administered to patients who suffer from stomach ulcers or hyperacidity. (BSH, 39; HM, 382) Occasional cases of allergic dermatitis reported. (WHO1, 121; PPP, 578) Care should be exercised with women wishing to conceive and patients complaining of hair loss. (CGBLH, 436) Patients applying topical doses should be cautioned against excessive exposure to sunlight. (PPP, 578) None known. (HM, 382; TGHM, 222; ESCOPM, 108) High doses (>15 g/day) should not be given to patients taking antiplatelet or anticoagulant drugs. (PPP, 578; CGBLH, 436) Turmeric Curcuma longa rhizome Note: 2b, 2d The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 No information. Refer to the MediHerb Herb-Drug Interactions chart. Refer to the MediHerb Herb-Drug Interactions chart. The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 11 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Broncafect® Contraindicated in high blood pressure, edema (water retention), congestive heart failure, low blood potassium, pregnancy and lactation. Contraindicated in known allergy to plants of the daisy family. Licorice Glycyrrhiza glabra root 2b, 2c, 2d It is recommended that patients with cardiovascular or renal disease use licorice only under care of health care professional. (TCPHP, 232; PPP, 474) Patients prone to potassium deficiency are also advised not to use licorice. (TCPHP, 232; TGHM, 161) Treatment not to exceed six weeks. (TCPHP, 232; BSH, 58; TGHM, 162) Contraindications: hypertension, cholestatic liver disorders, inflammatory liver disorders, liver cirrhosis, hypertonia, hypokalemia, severe obesity and severe kidney insufficiency (HM, 236; BSH, 58; BHC, 146; TGHM, 161; WHO1, 190; AEHD3, 72; ESCOPM, 298) pregnancy and lactation (ESCOPM, 298). In the case of pregnancy doses up to 3 g per day are likely to be safe. (PPP, 474) Also contraindicated if there is edema or congestive heart failure. (PPP, 474) Caution is advised with elderly patients. (CGBLH, 312) Ingestion of an excessive amount can lead to severe hypertension, cardiac arrhythmias, cardiomyopathy, cardiac arrest, pseudoaldosteronism, myopathy, pulmonary and generalized edema. (AEHD3, 73; BSH, 58; BHC, 146; AEHD3, 72; CGBLH, 313) Should not be taken concurrently with corticosteroid treatment. (WHO1, 190; AEHD3, 77) May decrease plasma clearance and increase the AUC of prednisolone. Licorice may potentiate the activity of prednisolone and other corticosteroid drugs. (ESCOPM, 298; CGBLH, 313) Concurrent use of furosemide may potentiate development of acute renal failure. (AEHD3, 77) Potassium loss due to other drugs, e.g. thiazide diuretics, can be increased. With potassium loss, sensitivity to digitalis glycosides increases. (HM, 237; TGHM, 161; WHO1, 190) Excessive use of licorice may interact with antiarrhythmic drugs or with drugs which induce reversion to sinus rhythm (e.g. quinidine). (ESCOPM, 298) Should not be administered in conjunction with spironolactone or amiloride. (WHO1, 190) Insulin may be synergistic with glycyrrhizin in causing electrolyte disturbances and suppression of renin and aldosterone. (AEHD3, 77) There is a slight chance that licorice may counteract the contraceptive pill, on the basis of the constituent glycyrrhizin. (CGBLH, 312) Refer to the MediHerb Herb-Drug Interactions chart. Pleurisy Root Asclepias tuberosa root 2b, 2d Canadian regulations do not allow the herb as a nonNone known. (CGBLH, 374) medicinal ingredient for oral use products. (BSH, 17) However no adverse effects have been documented for recommended dosages. (CGBLH, 374) Echinacea Echinacea purpurea root 1 Commission E cautioned that Echinacea pallida root should not be used in systemic diseases such as tuberculosis, leukosis, collagenosis, multiple sclerosis, AIDS, HIV infections, and other autoimmune diseases (based on theoretical considerations and not on any reports of adverse findings). Other authoritative sources do not support these restrictions. (TGHM, 121; PPP, 359-360) Should not be administered to patients with known allergy to any plant of Asteraceae (Compositae). (ESCOPM, 137) Allergic reactions, mainly contact dermatitis, may occur rarely in susceptible patients from Echinacea aerial parts. The likelihood of Echinacea root preparations causing allergy is very low. (CGBLH, 185) None known. (ESCOPM, 137; PPP, 360) Caution is advised for transplant patients taking immunosuppressive drugs, short-term therapy only is suggested. (PPP, 360; CGBLH, 185) Large doses can be laxative. (BSH, 74) None known. (TGHM, 148; HM, 199; CGBLH, 456) White Horehound Marrubium vulgare herb 2b Refer to the MediHerb Herb-Drug Interactions chart. Continues on next page Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 12 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Ginger Zingiber officinale rhizome 2b, 2d Thyme Thymus vulgaris leaf essential oil Contraindications, Cautions and Potential Adverse Reactions Contraindicated with gallstones; consult a physician first. (HM, 156; BSH, 125; TGHM, 136) May increase the chance of bleeding. (PPP, 401) A daily dose of 2 g of dried ginger should not be exceeded in pregnancy. Use with caution in cases of peptic ulceration, gastroesophageal reflux, or other gastric diseases. At doses approaching or greater than the maximum recommended dose, an increase in gastric secretory activity leading to heartburn is possible. (CGBLH, 227) Overdose may lead to a blood-thinning effect and an increase in gastric secretory activity leading to heartburn. (PPP, 401; ESCOPM, 548) Topical application may cause contact dermatitis in sensitive patients. (PPP, 401) No information. None known for an oral daily dose of 0.5 mL or above. (EOS, 113-114, 176) Substantial doses should be avoided in pregnancy. (BSH, 116) Interactions with Drugs None known. (HM, 156; TGHM, 136) May increase the absorption of pharmaceutical drugs. (PPP, 401) Caution indicated for daily doses of (dried) ginger in excess of 4 g with patients taking blood-thinning drugs such as warfarin, or aspirin or who have increased risk of hemorrhage. (PPP, 401; TCPHP, 129; CAACH, 106; CGBLH, 227) May enhance absorption of sulphaguanidine. (ESCOPM, 548) Refer to the MediHerb Herb-Drug Interactions chart. No information. Broncafect Phytosynergist® Contraindicated in high blood pressure, edema (water retention), congestive heart failure, low blood potassium, pregnancy and lactation. Contraindicated in known allergy to plants of the daisy family. Echinacea Echinacea angustifolia root 1 Commission E cautioned that Echinacea pallida root and E. angustifolia herb and root should not be used in systemic diseases such as tuberculosis, leukosis, collagenosis, multiple sclerosis, AIDS, HIV infections, and other autoimmune diseases (based on theoretical considerations and not on any reports of adverse findings). Other authoritative sources do not support these restrictions. (HM, 94; TGHM, 121, 328; PPP, 359-360) Allergic reactions, mainly contact dermatitis, may occur rarely in susceptible patients from Echinacea aerial parts. The likelihood of Echinacea root preparations causing allergy is very low. (CGBLH, 185) None known. (HM, 95; PPP, 360) Caution is advised for transplant patients taking immunosuppressive drugs, short-term therapy only is suggested. (PPP, 360; CGBLH, 185) Refer to the MediHerb Herb-Drug Interactions chart. Continues on next page Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 13 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs 2b, 2c, 2d It is recommended that patients with cardiovascular or renal disease use licorice only under care of health care professional. (TCPHP, 232; PPP, 474) Patients prone to potassium deficiency are also advised not to use licorice. (TCPHP, 232; TGHM, 161) Treatment not to exceed six weeks. (TCPHP, 232; BSH, 58; TGHM, 162) Contraindications: hypertension, cholestatic liver disorders, inflammatory liver disorders, liver cirrhosis, hypertonia, hypokalemia, severe obesity and severe kidney insufficiency (HM, 236; BSH, 58; BHC, 146; TGHM, 161; WHO1, 190; AEHD3, 72; ESCOPM, 298) pregnancy and lactation (ESCOPM, 298). In the case of pregnancy doses up to 3 g per day are likely to be safe. (PPP, 474) Also contraindicated if there is edema or congestive heart failure. (PPP, 474) Caution is advised with elderly patients. (CGBLH, 312) Ingestion of an excessive amount can lead to severe hypertension, cardiac arrhythmias, cardiomyopathy, cardiac arrest, pseudoaldosteronism, myopathy, pulmonary and generalized edema. (AEHD3, 73; BSH, 58; BHC, 146; AEHD3, 72; CGBLH, 313) Should not be taken concurrently with corticosteroid treatment. (WHO1, 190; AEHD3, 77) May decrease plasma clearance and increase the AUC of prednisolone. Licorice may potentiate the activity of prednisolone and other corticosteroid drugs. (ESCOPM, 298; CGBLH, 313) Concurrent use of furosemide may potentiate development of acute renal failure. (AEHD3, 77) Potassium loss due to other drugs, e.g. thiazide diuretics, can be increased. With potassium loss, sensitivity to digitalis glycosides increases. (HM, 237; TGHM, 161; WHO1, 190) Excessive use of licorice may interact with antiarrhythmic drugs or with drugs which induce reversion to sinus rhythm (e.g. quinidine). (ESCOPM, 298) Should not be administered in conjunction with spironolactone or amiloride. (WHO1, 190) Insulin may be synergistic with glycyrrhizin in causing electrolyte disturbances and suppression of renin and aldosterone. (AEHD3, 77) There is a slight chance that licorice may counteract the contraceptive pill, on the basis of the constituent glycyrrhizin. (CGBLH, 312) Pleurisy Root Asclepias tuberosa root 2b, 2d Canadian regulations do not allow the herb as a nonNone known. (CGBLH, 374) medicinal ingredient for oral use products. (BSH, 17) However no adverse effects have been documented for recommended dosages. (CGBLH, 374) Thyme Thymus vulgaris leaf 1 None known. (HM, 377; TGHM, 219; WHO1, 264; Patients sensitive to birch pollen or celery may have CGBLH, 431) cross-sensitivity or possible adverse reaction to this herb. Contact dermatitis has been reported. (WHO1, 264) Classifications and concerns for this herb are based upon therapeutic use and dosage and may not be relevant to its consumption as a spice. (BSH, 116) Ginger Zingiber officinale rhizome 2b, 2d Contraindicated with gallstones; consult a physician first. (HM, 156; BSH, 125; TGHM, 136) May increase the chance of bleeding. (PPP, 401) A daily dose of 2 g of dried ginger should not be exceeded in pregnancy. Use with caution in cases of peptic ulceration, gastroesophageal reflux, or other gastric diseases. At doses approaching or greater than the maximum recommended dose, an increase in gastric secretory activity leading to heartburn is possible. (CGBLH, 227) Overdose may lead to a blood-thinning effect and an increase in gastric secretory activity leading to heartburn. (PPP, 401; ESCOPM, 548) Topical application may cause contact dermatitis in sensitive patients. (PPP, 401) None known. (HM, 156; TGHM, 136) May increase the absorption of pharmaceutical drugs. (PPP, 401) Caution indicated for daily doses of (dried) ginger in excess of 4 g with patients taking blood-thinning drugs such as warfarin, or aspirin or who have increased risk of hemorrhage. (PPP, 401; TCPHP, 129; CAACH, 106; CGBLH, 227) May enhance absorption of sulphaguanidine. (ESCOPM, 548) Large doses can be laxative. (BSH, 74) None known. (TGHM, 148; HM, 199; CGBLH, 456) Product and Ingredient Name Class Licorice Glycyrrhiza glabra root Refer to the MediHerb Herb-Drug Interactions chart. White Horehound Marrubium vulgare herb Note: 2b The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 Refer to the MediHerb Herb-Drug Interactions chart. The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 14 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Burdock Complex Contraindicated in pregnancy and lactation. Burdock Arctium lappa root 1 None known. (BHC, 46; TGHM, 318) None known. (CGBLH, 118) Sheep Sorrel Rumex acetosella herb 2d Individuals with a history of kidney stones should use the herb cautiously. (BSH, 100) No information. Slippery Elm Ulmus rubra stem bark 1 None known. (BHC, 204) Mucilage such as slippery elm None known. (BHC, 204) is inappropriately prescribed in congestive bronchial and catarrhal conditions. (PPP, 169) Since they have been known to cause esophageal obstruction, mucilages should be taken with plenty of water and large doses should not be prescribed in tablet form. (PPP, 26) Rhubarb Rheum palmatum root 2b, 2c, 2d Contraindicated in intestinal obstruction, acute intestinal inflammation e.g. Crohn's disease, ulcerative colitis, appendicitis, abdominal pain of unknown origin, (TGHM, 195) pregnancy, lactation and children under 10 years of age. (ESCOPM, 420) In single incidents, cramp-like discomforts of the gastrointestinal tract can occur. This requires a dosage reduction. With chronic use or abuse a range of side effects are possible due to disturbance of water and electrolyte balance, especially potassium deficiency which can lead to disorders of heart function and muscular weakness. Pigment implantation into the intestinal mucosa (pseudomelanosis coli) can occur but it is harmless and usually reverses upon discontinuation of the herb. (TGHM, 195) Laxatives containing anthraquinone glycosides such as rhubarb are also contraindicated in patients with bowel disease, diarrhea and constipation associated with bowel impermeability. (PPP, 173) They should not be used for periods of more than 2 weeks without medical advice. (ESCOPM, 420) Abdominal spasm and pain may occur in those with irritable colon. A non-clinically relevant discoloration of urine may also occur. (ESCOPM, 420) Although it is often recommended that individuals with a history of kidney stones should use the herb cautiously, on the basis of it containing oxalate, (BSH, 97) this side effect has not been established. Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 With long-term use or abuse, due to loss of potassium, an increase in effectiveness of cardiac glycosides and an effect on antiarrhythmic drugs is possible. Potassium deficiency can be increased by simultaneous application of thiazide diuretics, corticosteroids or licorice root. (TGHM, 196) The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 15 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Capsella Complex Phytosynergist® Contraindicated in pregnancy. Contraindicated during lactation unless otherwise directed by a qualified health care professional. Dong Quai Angelica polymorpha (Angelica sinensis) root 2b Contraindicated in bleeding or very heavy menstruation, first trimester of pregnancy, tendency to spontaneous abortion, acute viral infections such as colds or influenza. (CAACH, 5-6; BSH, 11; PPP, 352; CGBLH, 182) Also contraindicated in diarrhea caused by weak digestion and in hemorrhagic disease. (PPP, 352) Headache may occur in sensitive individuals. (WHO2, 32) Cardiovascular side effects include excessive bleeding. (TCPHP, 290) A case of gynecomastia in a male has been reported. (CGBLH, 182) Dong quai has two furanocoumarins (psoralen and bergapten), which are photoreactive and have the potential to cause severe photodermatitis. These furanocoumarins are also photocarcinogenic. However, the risk of phototoxicity in humans from ingestion of dong quai has not been characterized. (TCPHP, 290-291) Based on animal studies, caution is advised for patients receiving chronic treatment with anticoagulant drugs such as Coumadin (warfarin). (PPP, 352) Refer to the MediHerb Herb-Drug Interactions chart. False Unicorn Chamaelirium luteum root 2b Excessive doses may produce nausea and vomiting. None known. (BHC, 125; CGBLH, 204) (BHC, 125) Canadian regulations do not allow this herb as a non-medicinal ingredient for oral use products. (BSH, 27) Very large doses are said to cause nausea and vomiting. (CGBLH, 204) Shepherd’s Purse Capsella bursa-pastoris herb 2b, 2d Large doses may cause heart palpitations; individuals with history of kidney stones should use cautiously. (BSH, 23; HM, 351) None known. (TGHM, 208; HM, 352; CGBLH, 413) Consult with a physician when patient has breast cancer condition. (PPP, 244) The herb reduces testosterone production from ovaries but not from adrenal glands. (CAACH, 31) None known. (CGBLH, 458) Should not be combined with Fritillaria verticillata, Cuscuta japonica and Rheum officinale. (WHO1, 199) Caution should be exercised when used with estrogenic drugs or anticoagulant drugs. (PPP, 244; CGBLH, 458) White Peony Paeonia lactiflora root Note: 1 The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 Refer to the MediHerb Herb-Drug Interactions chart (under Polyphenolic- or Flavonoid-containing herbs). The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 16 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Cat's Claw Complex Contraindicated in pregnancy and lactation. Contraindicated in patients taking anticoagulant drugs. Contraindicated in known allergy to plants of the daisy family. Cat’s Claw Uncaria tomentosa inner stem bark 4 Pau d’Arco 1 Tabebuia avellanedae inner stem bark None known. (CGBLH, 131) Contraindicated in patients undergoing skin grafts and organ transplants; hemophiliacs prescribed fresh blood plasma; simultaneous administration of certain vaccines, hormone therapies, thymus extracts, and insulin and children under three years of age. (BSH, 119) Use with caution in pregnancy and lactation. Diarrhea and indigestion have been reported in several patients. (CGBLH, 131) Contraindicated with anticoagulants. (PPP, 504) Adverse effects are not expected when consumed with the recommended dosage. (PPP, 500) Caution is advised in pregnancy. (CGBLH, 366) Patients on anticoagulant therapy should not be prescribed pau d’arco due to the warfarin-like action of naphthoquinones at high doses. (PPP, 504) Refer to the MediHerb Herb-Drug Interactions chart. Echinacea Echinacea purpurea root 1 Commission E cautioned that Echinacea pallida root should not be used in systemic diseases such as tuberculosis, leukosis, collagenosis, multiple sclerosis, AIDS, HIV infections, and other autoimmune diseases (based on theoretical considerations and not on any reports of adverse findings). Other authoritative sources do not support these restrictions. (TGHM, 121; PPP, 359-360) Should not be administered to patients with known allergy to any plant of Asteraceae (Compositae). (ESCOPM, 137) Allergic reactions, mainly contact dermatitis, may occur rarely in susceptible patients from Echinacea aerial parts. The likelihood of Echinacea root preparations causing allergy is very low. (CGBLH, 185) None known. (ESCOPM, 137; PPP, 360) Caution is advised for transplant patients taking immunosuppressive drugs, short-term therapy only is suggested. (PPP, 360; CGBLH, 185) Refer to the MediHerb Herb-Drug Interactions chart. Chaste Tree Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Chaste Tree Vitex agnus-castus fruit Note: 2b, 2d Contraindicated in conjunction with progesterone drugs, the contraceptive pill, or HRT. (PPP, 332; BSH, 123; ESCOPM, 9) The herb may aggravate pure spasmodic dysmenorrhea not associated with PMS. (PPP, 332) Rare occurrences of itching, urticaria and headache have been reported. (PPP, 333; BSH, 123; HM, 63; TGHM, 108; ESCOPM, 9; CGBLH, 142) Should be used cautiously during pregnancy and only in the early stages for treating insufficient corpus luteal function. (CGBLH, 142) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 May interact antagonistically with dopamine receptor antagonists, progesterone drugs, contraceptive pill or HRT. (PPP, 332; HM, 63; TGHM, 108; CGBLH, 142) The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 17 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs ChelaCo Contraindicated in known allergy to Garlic. Contraindicated in lactation. Not to be used during pregnancy unless otherwise directed by a qualified health care professional. In anemia and cases where iron supplementation is required, do not take simultaneously with meals or iron supplements. Hawthorn Crataegus monogyna herb flowering tops Milk Thistle Silybum marianum fruit Garlic Allium sativum bulb Note: 1 1 2c Occasional side effects include gastrointestinal disorders, palpitation, headache, dizziness, circulatory disturbances, sleeplessness and inner agitation. (CGBLH, 270) A physician must be consulted in cases where symptoms continue unchanged for longer than six weeks or when fluid accumulates in the legs. Medical diagnosis is absolutely necessary when pains occur in the region of the heart, spreading out to the arms, upper abdomen or the area around the neck, or in cases of respiratory distress (shortness of breath). (TGHM, 143; ESCOPM, 99; WHO2, 77) In 1997, it was noted that in Canada, the herb carries new drug status and is not approved, as self-treatment of cardiovascular conditions is deemed inappropriate. (TCPHP, 257) Hawthorn preparations may have a potentiating effect which may necessitate a smaller dosage of digitalis,(PPP, 446; BSH, 37) though this action has not been confirmed. (HM, 186) Hawthorn preparations may act in synergy with beta-blockers and other hypotensive drugs. Modification of drug dosage may be required. (PPP, 446; CGBLH, 270; TCPHP, 257) Contraindicated in cases of known allergy to plants of the Asteraceae (Compositae) family. (WHO2, 310) Side effect: a mild laxative effect and mild gastrointestinal complaints have been observed in occasional instances from the standardized preparation. (HM, 260; TGHM, 170; WHO2, 310; CGBLH, 326) None known. (PPP, 560; HM, 261; TGHM, 170) Contraindication with gastrointestinal disturbance; in rare instances, there may be changes to the flora of the intestine, or allergic reactions. (TGHM, 134; HM, 145; BSH, 6; BHC, 106) Fresh garlic, extracts or oil may also cause heartburn, nausea, vomiting, and diarrhea if taken on an empty stomach. (WHO1, 26) Garlic intake should be discontinued 10 days before surgery. (PPP, 200) May increase the risk of postoperative bleeding. (WHO1, 25; ESCOPM, 15; AEHD3, 229) Contact allergy is noted. (AEHD1, 74; WHO1, 26) Hematologic concern based upon in vitro data and case reports for garlic and garlic oil. [Editor’s note: the results of case reports are conflicting.] (TCPHP, 110, 111, 301) None known. (TGHM, 134) Garlic’s antiplatelet effect might be dangerous in patients taking warfarin or antiplatelet agents such as aspirin, ticlopidine, clopidogrel, or dipyridamole. (TCPHP, 118; HM, 115; WHO1, 25) An interaction has been observed in two patients taking warfarin. (ESCOPM, 15) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 Refer to the MediHerb Herb-Drug Interactions chart (under Hawthorn and Tannin- or OPC-containing herbs). Refer to the MediHerb Herb-Drug Interactions chart (under Milk Thistle and Polyphenolic- or Flavonoidcontaining herbs). Refer to the MediHerb Herb-Drug Interactions chart. The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 18 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Colax Contraindicated in closure of the gallbladder and in known allergy to plants of the daisy family. Use only with professional supervision in gallstones. This product contains Rhamnus purshiana (Cascara). Read and follow directions carefully. Do not use if you have or develop diarrhea, loose stools, or abdominal pain because Cascara may worsen these conditions and be harmful to your health. Consult your health care professional if you have frequent diarrhea or if you are pregnant, nursing, taking medication, or have a medical condition. Cascara Rhamnus purshiana stem bark 2b, 2d Contraindicated in intestinal obstruction, acute intestinal inflammation e.g. Crohn's disease, ulcerative colitis, appendicitis; abdominal pain of unknown origin, colic, hemorrhoids, nephritis (TGHM, 104; HM, 49; WHO2, 264) pregnancy, lactation, (BHC, 52) children under 10 years of age and patients with severe dehydration states with water and electrolyte depletion. (ESCOPM, 414) Fresh or inadequately prepared cascara bark should not be used because severe vomiting and intestinal spasm can result. (CGBLH, 127) In single incidents, cramp-like discomforts of the gastrointestinal tract can occur. This requires a dosage reduction. With chronic use or abuse a range of side effects are possible due to disturbance of water and electrolyte balance, especially potassium deficiency which can lead to disorders of heart function and muscular weakness. Pigment implantation into the intestinal mucosa (pseudomelanosis coli) can occur but it is harmless and usually reverses upon discontinuation of the herb. (TGHM, 105; HM, 49) Laxatives containing anthraquinone glycosides such as cascara are also contraindicated in patients with bowel disease, diarrhea and constipation associated with bowel impermeability. (PPP, 173) They should not be used for periods of more than 2 weeks without medical advice. (ESCOPM, 414; WHO2, 264) Abdominal spasm and pain may occur in those with irritable colon. A non-clinically relevant discoloration of urine may also occur. (ESCOPM, 414) Increased intestinal transit time may result in reduced absorption of orally administered drugs. (WHO2, 264) With long-term use or abuse, due to loss of potassium, an increase in effectiveness of cardiac glycosides and an effect on antiarrhythmic drugs is possible. Potassium deficiency can be increased by simultaneous application of thiazide diuretics, corticosteroids or licorice root. (TGHM, 105; HM, 49) Refer to the MediHerb Herb-Drug Interactions chart. Dandelion Root Taraxacum officinale root None known. (TGHM, 119; HM, 80, 81; ESCOPM, No information. Contraindicated or at least inappropriate in the 503; CGBLH, 173) following: (1) obstructed bile ducts, (2) unconjugated hyperbilirubinemia, (3) acute or severe hepatocellular disease, (4) septic cholecystitis (where there is risk of peritonitis), (5) intestinal spasm or ileus, (6) liver cancer and (7) gall bladder empyema. (PPP, 187; BHC, 73, 76; ESCOPM, 503; BSH, 114) In case of gallstones, first consult a physician. (HM, 80, 81) May cause superacidic stomach problems. (BSH, 114) Yellow Dock Rumex crispus root 2d Use with caution in pregnancy. (CGBLH, 474) Contraindicated or at least inappropriate in constipation associated with bowel irritability, bowel disease, diarrhea. (PPP, 173) Individuals with a history of kidney stones should use cautiously. (BSH, 100) None known. (CGBLH, 474) Refer to the MediHerb Herb-Drug Interactions chart. Continues on next page Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 19 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Product and Ingredient Name Class Dill Seed Anethum graveolens seed 1 May be contraindicated or inappropriate in gastroesophageal reflux. (This applies to leaf and essential oil.) (PPP, 29, 171) None known. (TGHM, 121) Chamomile Matricaria recutita flower 1 Contraindicated in known allergy to chamomile or other members of the Compositae family. (CGBLH, 137) May cause rare contact allergy. (BHC, 155) Allergic concern based upon case reports. (TCPHP, 301) Highly concentrated hot tea is noted as emetic. (BSH, 74) German Standard License requires the following label: “The infusion should not be used near the eyes.” (BSH, 74) The pollen contained in these infusions appears to be responsible for the allergic reaction. (CGBLH, 138) None known. (TGHM, 107; HM, 60; BHC, 155) Avoid concomitant administration of chamomile during iron intake. In anemia and cases for which iron supplementation is required, chamomile should not be taken simultaneously with meals or iron supplements. (CGBLH, 137-138) Refer to the MediHerb Herb-Drug Interactions chart (under Polyphenolic- or Flavonoid-containing herbs). Coleus Forte Contraindicated in hypotension. Contraindicated in gastric or duodenal ulcers unless otherwise directed by a qualified health care professional. Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Do not use this product while taking any prescription drug(s) without the advice of your prescribing physician. Coleus Coleus forskohlii root No information. Contraindicated in hypotension. (CAACH, 106) Use cautiously in peptic ulcer. (CGBLH, 156) Forskolin has the ability to potentiate many drugs. Use cautiously in patients taking prescribed medication, especially hypotensive and antiplatelet drugs. (CAACH, 106; CGBLH, 156) Refer to the MediHerb Herb-Drug Interactions chart. Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 20 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Cramplex Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Corydalis Corydalis ambigua tuber Caution is advised in patients concurrently No information. Contraindication: pregnancy. (CAACH, 28) Caution is consuming powerful analgesics. (PPP, 232) advised in prescribing for children, and patients with neurological disease, depression, psychosis, liver and kidney disease or those with a history of allergic or anaphylactic reactions. (PPP, 232) Herbal sedatives such as corydalis are also contraindicated in patients with depression and insomnia marked by increasing restlessness during the early hours of the morning. (PPP, 233) Raspberry Leaf Rubus idaeus leaf 1 Use cautiously in patients with highly inflamed, ulcerated or damaged gastrointestinal tissue. (PPP, 37) No adverse effects expected in pregnancy or lactation, but confining use to the second and third trimesters is more appropriate. (CGBLH, 381) Tannin-containing herbs may reduce the absorption of pharmacological substances e.g. metal ions (iron supplements) and thiamine. Avoid concurrent consumption. (PPP, 37, 103) Refer to the MediHerb Herb-Drug Interactions chart (under Tannin- or OPC-containing herbs). Wild Yam Dioscorea villosa root & rhizome 1 Cramp Bark Viburnum opulus stem bark None known. (CGBLH, 164) No information. Nausea and vomiting may occur with large doses. (CGBLH, 100) Canadian regulations do not allow cramp bark as a non-medicinal ingredient for oral use products. (BSH, 122) Ginger Zingiber officinale rhizome 2b, 2d Note: Large doses produce emesis. (BSH, 42) Oral use may cause irritation of the gastric mucous membranes and reflux. (CGBLH, 464) Also classified as choleretic and cholagogue, the herb is either contraindicated or at least inappropriate in the following: (1) obstructed bile ducts, (2) unconjugated hyperbilirubinemia, (3) acute or severe hepatocellular disease, (4) septic cholecystitis (where there is risk of peritonitis), (5) intestinal spasm or ileus, and (6) liver cancer. (PPP, 187) Contraindicated with gallstones; consult a physician first. (HM, 156; BSH, 125; TGHM, 136) May increase the chance of bleeding. (PPP, 401) A daily dose of 2 g of dried ginger should not be exceeded in pregnancy. Use with caution in cases of peptic ulceration, gastroesophageal reflux, or other gastric diseases. At doses approaching or greater than the maximum recommended dose, an increase in gastric secretory activity leading to heartburn is possible. (CGBLH, 227) Overdose may lead to a blood-thinning effect and an increase in gastric secretory activity leading to heartburn. (PPP, 401; ESCOPM, 548) Topical application may cause contact dermatitis in sensitive patients. (PPP, 401) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 None known. (CGBLH, 464) Consult physician when patient is being treated with estrogen-promoting drugs. (PPP, 46, 245) The herb is contraindicated or at least inappropriate when there is already prescription of strong anti-inflammatory medication. (PPP, 149) None known. (HM, 156; TGHM, 136) May increase the absorption of pharmaceutical drugs. (PPP, 401) Caution indicated for daily doses of (dried) ginger in excess of 4 g with patients taking blood-thinning drugs such as warfarin, or aspirin or who have increased risk of hemorrhage. (PPP, 401; TCPHP, 129; CAACH, 106; CGBLH, 227) May enhance absorption of sulphaguanidine. (ESCOPM, 548) Refer to the MediHerb Herb-Drug Interactions chart. The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 21 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Cranberry Complex Contraindicated in kidney disease. Contraindicated in pregnancy and lactation. Crataeva Crataeva nurvala stem bark No information. None known. (CGBLH, 168) None known. (CGBLH, 168) Uva Ursi Arctostaphylos uva-ursi leaf 2b, 2d Should not be given with treatments that will lead to the production of acidic urine (leading to a reduction of antibacterial effect). The high tannin content could interfere with the absorption of some nutrients. (CGBLH, 444) Cranberry Vaccinium macrocarpon fruit Buchu Barosma betulina leaf essential oil Note: Large doses may cause nausea and vomiting. (HM, 391; BHC, 212) May also cause cramping and constipation, due to high tannin content. Not suitable for longterm use. (PPP, 284; ESCOPM, 536; CGBLH, 444) Contraindications: kidney disorders, renal failure, which may be theoretical, and pregnancy. (BHC, 212; PPP, 223, 284; BSH, 13; ESCOPM, 536-537) Refer to the MediHerb Herb-Drug Interactions chart (under Tannin- or OPC-containing herbs). No information. Ingestion of large amounts of cranberry juice (more than 3 liters per day) may result in diarrhea and other gastrointestinal symptoms. (TCPHP, 158) No information. No information. Constituents in the essential oil can cause irritation. (TGHM, 317) At an oral daily dose of 0.5 mL or above: use with caution; should not be taken in pregnancy and children up to 2 years of age. (EOS, 113-114, 124) No information. The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 Refer to the MediHerb Herb-Drug Interactions chart. The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 22 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs DermaCo Contraindicated in pregnancy and lactation. Oregon Grape Berberis aquifolium (Mahonia aquifolium) root & rhizome 2b Berberine, an alkaloid constituent of this herb, may Canadian regulations require bilingual label warning potentiate other drugs which displace the protein against use in pregnancy and is an unacceptable nonbinding of bilirubin. (PPP, 295) medicinal ingredient in oral use products. (BSH, 73) Contraindicated in pregnancy, and jaundiced neonates. (CGBLH, 80) This herb is classified as a choleretic and cholagogue. It is either contraindicated or at least inappropriate in the following: (1) obstructed bile ducts, (2) unconjugated hyperbilirubinemia, (3) acute or severe hepatocellular disease, (4) septic cholecystitis (where there is risk of peritonitis), (5) intestinal spasm or ileus, and (6) liver cancer. (PPP, 187) As an alterative, this herb may be provocative to skin disease, and care needs to be taken to reduce the prospects of exacerbations. (PPP, 254) Sarsaparilla Smilax ornata root & rhizome 1 Risks: taking the herb may lead to gastric irritation and temporary kidney impairment (diuresis). The absorption of simultaneously administered substances may be increased. The elimination of other substances (e.g., hypnotics) is accelerated. This can cause an uncontrolled condition of increased or decreased action of herbs taken simultaneously. (TGHM, 372) These concerns are theoretical, and not established by animal studies or case reports. (CGBLH, 397) Commission E advises of potential drug interactions with hypnotics, digitalis glycosides, and bismuth. However, no other reference substantiates these concerns. (BSH, 108) Such concerns would be alleviated by not taking sarsaparilla simultaneously with drug medication. (CGBLH, 397) Cleavers Galium aparine herb 1 This herb may be provocative to skin disease, and care needs to be taken to reduce the prospects for major exacerbations. (PPP, 254) None known. (BHC, 61; CGBLH, 152) Burdock Arctium lappa root 1 None known. (BHC, 46; TGHM, 318) None known. (CGBLH, 118) Yellow Dock Rumex crispus root 2d Use with caution in pregnancy. (CGBLH, 474) Contraindicated or at least inappropriate in constipation associated with bowel irritability, bowel disease, diarrhea. (PPP, 173) Individuals with a history of kidney stones should use cautiously. (BSH, 100) None known. (CGBLH, 474) Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 Refer to the MediHerb Herb-Drug Interactions chart. The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 23 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs DiaCo Phytosynergist® Contraindicated in high blood pressure, edema (water retention), congestive heart failure, low blood potassium, pregnancy and lactation. Contraindicated in known allergy to plants of the daisy family. Echinacea Echinacea angustifolia root 1 Commission E cautioned that Echinacea pallida root and E. angustifolia herb and root should not be used in systemic diseases such as tuberculosis, leukosis, collagenosis, multiple sclerosis, AIDS, HIV infections, and other autoimmune diseases (based on theoretical considerations and not on any reports of adverse findings). Other authoritative sources do not support these restrictions. (HM, 94; TGHM, 121, 328; PPP, 359-360) Allergic reactions, mainly contact dermatitis, may occur rarely in susceptible patients from Echinacea aerial parts. The likelihood of Echinacea root preparations causing allergy is very low. (CGBLH, 185) None known. (HM, 95; PPP, 360) Caution is advised for transplant patients taking immunosuppressive drugs, short-term therapy only is suggested. (PPP, 360; CGBLH, 185) Refer to the MediHerb Herb-Drug Interactions chart. Elder Flower Sambucus nigra flower 1 Diuretic mechanism indicates potassium loss, a potassium supplement may be indicated. (PPP, 221) None known. (HM, 104; TGHM, 124; CGBLH, 191) Lime Flower Tilia cordata flower 1 Regulated in the U.S. as an allowable flavoring agent in alcoholic beverages only. (BSH, 116) Allergic reaction occurs rarely. (AEHD2, 304; CGBLH, 318) None known. (HM, 241; TGHM, 342) Avoid concomitant administration of lime flower during iron intake. In anemia and cases for which iron supplementation is required, lime flower should not be taken simultaneously with meals or iron supplements. (CGBLH, 318) Refer to the MediHerb Herb-Drug Interactions chart (under Polyphenolic- or Flavonoid-containing herbs). Yarrow Achillea millefolium herb 2b Yarrow is an antispasmodic and may be contraindicated None known. (HM, 421; TGHM, 234; CGBLH, 471) or inappropriate in gastric and enteric poisoning incidents. (PPP, 172) May increase menstrual blood flow, not by uterine contraction, but by regulating the blood vessels in the uterus. (BSH, 171) Contraindication: known hypersensitivity to Yarrow or other Compositae. (BHC, 228; HM 421; TGHM, 233) Some authorities advise immediate cessation of treatment in the event of “itching and inflammatory changes in the skin” for persons prone to allergies to Asteraceae (Compositae). (BSH, 3) Thujone-containing varieties should be avoided during pregnancy and lactation. (CGBLH, 471) Ginger Zingiber officinale rhizome 2b, 2d Contraindicated with gallstones; consult a physician first. (HM, 156; BSH, 125; TGHM, 136) May increase the chance of bleeding. (PPP, 401) A daily dose of 2 g of dried ginger should not be exceeded in pregnancy. Use with caution in cases of peptic ulceration, gastroesophageal reflux, or other gastric diseases. At doses approaching or greater than the maximum recommended dose, an increase in gastric secretory activity leading to heartburn is possible. (CGBLH, 227) Overdose may lead to a blood-thinning effect and an increase in gastric secretory activity leading to heartburn. (PPP, 401; ESCOPM, 548) Topical application may cause contact dermatitis in sensitive patients. (PPP, 401) None known. (HM, 156; TGHM, 136) May increase the absorption of pharmaceutical drugs. (PPP, 401) Caution indicated for daily doses of (dried) ginger in excess of 4 g with patients taking blood-thinning drugs such as warfarin, or aspirin or who have increased risk of hemorrhage. (PPP, 401; TCPHP, 129; CAACH, 106; CGBLH, 227) May enhance absorption of sulphaguanidine. (ESCOPM, 548) Refer to the MediHerb Herb-Drug Interactions chart. Continues on next page Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 24 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Licorice Glycyrrhiza glabra root 2b, 2c, 2d Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs It is recommended that patients with cardiovascular or renal disease use licorice only under care of health care professional. (TCPHP, 232; PPP, 474) Patients prone to potassium deficiency are also advised not to use licorice. (TCPHP, 232; TGHM, 161) Treatment not to exceed six weeks. (TCPHP, 232; BSH, 58; TGHM, 162) Contraindications: hypertension, cholestatic liver disorders, inflammatory liver disorders, liver cirrhosis, hypertonia, hypokalemia, severe obesity and severe kidney insufficiency (HM, 236; BSH, 58; BHC, 146; TGHM, 161; WHO1, 190; AEHD3, 72; ESCOPM, 298) pregnancy and lactation (ESCOPM, 298). In the case of pregnancy doses up to 3 g per day are likely to be safe. (PPP, 474) Also contraindicated if there is edema or congestive heart failure. (PPP, 474) Caution is advised with elderly patients. (CGBLH, 312) Ingestion of an excessive amount can lead to severe hypertension, cardiac arrhythmias, cardiomyopathy, cardiac arrest, pseudoaldosteronism, myopathy, pulmonary and generalized edema. (AEHD3, 73; BSH, 58; BHC, 146; AEHD3, 72; CGBLH, 313) Should not be taken concurrently with corticosteroid treatment. (WHO1, 190; AEHD3, 77) May decrease plasma clearance and increase the AUC of prednisolone. Licorice may potentiate the activity of prednisolone and other corticosteroid drugs. (ESCOPM, 298; CGBLH, 313) Concurrent use of furosemide may potentiate development of acute renal failure. (AEHD3, 77) Potassium loss due to other drugs, e.g. thiazide diuretics, can be increased. With potassium loss, sensitivity to digitalis glycosides increases. (HM, 237; TGHM, 161; WHO1, 190) Excessive use of licorice may interact with antiarrhythmic drugs or with drugs which induce reversion to sinus rhythm (e.g. quinidine). (ESCOPM, 298) Should not be administered in conjunction with spironolactone or amiloride. (WHO1, 190) Insulin may be synergistic with glycyrrhizin in causing electrolyte disturbances and suppression of renin and aldosterone. (AEHD3, 77) There is a slight chance that licorice may counteract the contraceptive pill, on the basis of the constituent glycyrrhizin. (CGBLH, 312) Refer to the MediHerb Herb-Drug Interactions chart. Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 25 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs DiGest Contraindicated in gastric or duodenal ulcers unless otherwise directed by a qualified health care professional. Contraindicated in closure of the gallbladder. Use only with professional supervision in gallstones. Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Dandelion Root Taraxacum officinale root None known. (TGHM, 119; HM, 80, 81; ESCOPM, No information. Contraindicated or at least inappropriate in the 503; CGBLH, 173) following: (1) obstructed bile ducts, (2) unconjugated hyperbilirubinemia, (3) acute or severe hepatocellular disease, (4) septic cholecystitis (where there is risk of peritonitis), (5) intestinal spasm or ileus, (6) liver cancer and (7) gall bladder empyema. (PPP, 187; BHC, 73, 76; ESCOPM, 503; BSH, 114) In case of gallstones, first consult a physician. (HM, 80, 81) May cause superacidic stomach problems. (BSH, 114) Tangerine Citrus reticulata fruit peel 1 No information. No information. Milk Thistle Silybum marianum fruit 1 Contraindicated in cases of known allergy to plants of the Asteraceae (Compositae) family. (WHO2, 310) Side effect: a mild laxative effect and mild gastrointestinal complaints have been observed in occasional instances from the standardized preparation. (HM, 260; TGHM, 170; WHO2, 310; CGBLH, 326) None known. (PPP, 560; HM, 261; TGHM, 170) Contraindicated with gallstones; consult a physician first. (HM, 156; BSH, 125; TGHM, 136) May increase the chance of bleeding. (PPP, 401) A daily dose of 2 g of dried ginger should not be exceeded in pregnancy. Use with caution in cases of peptic ulceration, gastroesophageal reflux, or other gastric diseases. At doses approaching or greater than the maximum recommended dose, an increase in gastric secretory activity leading to heartburn is possible. (CGBLH, 227) Overdose may lead to a blood-thinning effect and an increase in gastric secretory activity leading to heartburn. (PPP, 401; ESCOPM, 548) Topical application may cause contact dermatitis in sensitive patients. (PPP, 401) None known. (HM, 156; TGHM, 136) May increase the absorption of pharmaceutical drugs. (PPP, 401) Caution indicated for daily doses of (dried) ginger in excess of 4 g with patients taking blood-thinning drugs such as warfarin, or aspirin or who have increased risk of hemorrhage. (PPP, 401; TCPHP, 129; CAACH, 106; CGBLH, 227) May enhance absorption of sulphaguanidine. (ESCOPM, 548) Contraindicated in gastric and duodenal ulcers, hyperacidity and when gastric irritation and inflammation are present. (BHC, 110; BSH, 56; TGHM, 135; HM, 150; ESCOPM, 174; CGBLH, 224) Contraindicated or at least inappropriate in conditions classed as ‘cold-dry’ in early medicine, involving ready shivering with dry cough and notably some kidney diseases. (PPP, 173) Headaches may occasionally occur in persons sensitive to bitter substances. (TGHM, 135; BSH, 56; ESCOPM, 175) Doses at the higher end of the recommended range in liquid form may cause nausea in some people. (CGBLH, 224) May not be welltolerated by persons with high blood pressure. (BSH, 56) None known. (HM, 151; TGHM, 135; ESCOPM, 175; CGBLH, 224) Ginger Zingiber officinale rhizome 2b, 2d Refer to the MediHerb Herb-Drug Interactions chart (under Milk Thistle and Polyphenolic- or Flavonoidcontaining herbs). Refer to the MediHerb Herb-Drug Interactions chart. Gentian Gentiana lutea root 2d Tangerine Citrus reticulata fruit peel essential oil No information. No information. No information. Chamomile Matricaria recutita flower essential oil No information. No information. No information. Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 26 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs DiGest Phytosynergist® Contraindicated in known allergy to plants of the daisy family. Contraindicated in gastric or duodenal ulcers unless otherwise directed by a qualified health care professional. Contraindicated in closure of the gallbladder. Use only with professional supervision in gallstones. Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Chamomile Matricaria recutita flower 1 Contraindicated in known allergy to chamomile or other members of the Compositae family. (CGBLH, 137) May cause rare contact allergy. (BHC, 155) Allergic concern based upon case reports. (TCPHP, 301) Highly concentrated hot tea is noted as emetic. (BSH, 74) German Standard License requires the following label: “The infusion should not be used near the eyes.” (BSH, 74) The pollen contained in these infusions appears to be responsible for the allergic reaction. (CGBLH, 138) None known. (TGHM, 107; HM, 60; BHC, 155) Avoid concomitant administration of chamomile during iron intake. In anemia and cases for which iron supplementation is required, chamomile should not be taken simultaneously with meals or iron supplements. (CGBLH, 137-138) Refer to the MediHerb Herb-Drug Interactions chart (under Polyphenolic- or Flavonoid-containing herbs). Dandelion Root Taraxacum officinale root None known. (TGHM, 119; HM, 80, 81; ESCOPM, No information. Contraindicated or at least inappropriate in the 503; CGBLH, 173) following: (1) obstructed bile ducts, (2) unconjugated hyperbilirubinemia, (3) acute or severe hepatocellular disease, (4) septic cholecystitis (where there is risk of peritonitis), (5) intestinal spasm or ileus, (6) liver cancer and (7) gall bladder empyema. (PPP, 187; BHC, 73, 76; ESCOPM, 503; BSH, 114) In case of gallstones, first consult a physician. (HM, 80, 81) May cause superacidic stomach problems. (BSH, 114) Echinacea Echinacea angustifolia root 1 Milk Thistle Silybum marianum seed Gentian Gentiana lutea root Note: 1 2d Commission E cautioned that Echinacea pallida root and E. angustifolia herb and root should not be used in systemic diseases such as tuberculosis, leukosis, collagenosis, multiple sclerosis, AIDS, HIV infections, and other autoimmune diseases (based on theoretical considerations and not on any reports of adverse findings). Other authoritative sources do not support these restrictions. (HM, 94; TGHM, 121, 328; PPP, 359-360) Allergic reactions, mainly contact dermatitis, may occur rarely in susceptible patients from Echinacea aerial parts. The likelihood of Echinacea root preparations causing allergy is very low. (CGBLH, 185) None known. (HM, 95; PPP, 360) Caution is advised for transplant patients taking immunosuppressive drugs, short-term therapy only is suggested. (PPP, 360; CGBLH, 185) Contraindicated in cases of known allergy to plants of the Asteraceae (Compositae) family. (WHO2, 310) Side effect: a mild laxative effect and mild gastrointestinal complaints have been observed in occasional instances from the standardized preparation. (HM, 260; TGHM, 170; WHO2, 310; CGBLH, 326) None known. (PPP, 560; HM, 261; TGHM, 170) Refer to the MediHerb Herb-Drug Interactions chart. Refer to the MediHerb Herb-Drug Interactions chart (under Milk Thistle and Polyphenolic- or Flavonoidcontaining herbs). None known. (HM, 151; TGHM, 135; ESCOPM, 175; Contraindicated in gastric and duodenal ulcers, hyperacidity and when gastric irritation and inflammation CGBLH, 224) are present. (BHC, 110; BSH, 56; TGHM, 135; HM, 150; ESCOPM, 174; CGBLH, 224) Contraindicated or at least inappropriate in conditions classed as ‘cold-dry’ in early medicine, involving ready shivering with dry cough and notably some kidney diseases. (PPP, 173) Headaches may occasionally occur in persons sensitive to bitter substances. (TGHM, 135; BSH, 56; ESCOPM, 175) Doses at the higher end of the recommended range in liquid form may cause nausea in some people. (CGBLH, 224) May not be well-tolerated by persons with high blood pressure. (BSH, 56) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 27 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Dong Quai Do not use in severe menorrhagia. Contraindicated in the first trimester of pregnancy, especially in higher doses. Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Dong Quai Angelica polymorpha (Angelica sinensis) root 2b Contraindicated in bleeding or very heavy menstruation, first trimester of pregnancy, tendency to spontaneous abortion, acute viral infections such as colds or influenza. (CAACH, 5-6; BSH, 11; PPP, 352; CGBLH, 182) Also contraindicated in diarrhea caused by weak digestion and in hemorrhagic disease. (PPP, 352) Headache may occur in sensitive individuals. (WHO2, 32) Cardiovascular side effects include excessive bleeding. (TCPHP, 290) A case of gynecomastia in a male has been reported. (CGBLH, 182) Dong quai has two furanocoumarins (psoralen and bergapten), which are photoreactive and have the potential to cause severe photodermatitis. These furanocoumarins are also photocarcinogenic. However, the risk of phototoxicity in humans from ingestion of dong quai has not been characterized. (TCPHP, 290-291) Based on animal studies, caution is advised for patients receiving chronic treatment with anticoagulant drugs such as Coumadin (warfarin). (PPP, 352) Refer to the MediHerb Herb-Drug Interactions chart. Echinacea Premium Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Contraindicated in known allergy to plants of the daisy family. Echinacea Echinacea angustifolia root Echinacea Echinacea purpurea root Note: 1 1 Commission E cautioned that Echinacea pallida root and E. angustifolia herb and root should not be used in systemic diseases such as tuberculosis, leukosis, collagenosis, multiple sclerosis, AIDS, HIV infections, and other autoimmune diseases (based on theoretical considerations and not on any reports of adverse findings). Other authoritative sources do not support these restrictions. (HM, 94; TGHM, 121, 328; PPP, 359-360) Allergic reactions, mainly contact dermatitis, may occur rarely in susceptible patients from Echinacea aerial parts. The likelihood of Echinacea root preparations causing allergy is very low. (CGBLH, 185) None known. (HM, 95; PPP, 360) Caution is advised for transplant patients taking immunosuppressive drugs, short-term therapy only is suggested. (PPP, 360; CGBLH, 185) Commission E cautioned that Echinacea pallida root should not be used in systemic diseases such as tuberculosis, leukosis, collagenosis, multiple sclerosis, AIDS, HIV infections, and other autoimmune diseases (based on theoretical considerations and not on any reports of adverse findings). Other authoritative sources do not support these restrictions. (TGHM, 121; PPP, 359-360) Should not be administered to patients with known allergy to any plant of Asteraceae (Compositae). (ESCOPM, 137) Allergic reactions, mainly contact dermatitis, may occur rarely in susceptible patients from Echinacea aerial parts. The likelihood of Echinacea root preparations causing allergy is very low. (CGBLH, 185) None known. (ESCOPM, 137; PPP, 360) Caution is advised for transplant patients taking immunosuppressive drugs, short-term therapy only is suggested. (PPP, 360; CGBLH, 185) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 Refer to the MediHerb Herb-Drug Interactions chart. Refer to the MediHerb Herb-Drug Interactions chart. The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 28 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Eleuthero Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Discontinue during an acute infection or fever. Eleuthero Eleutherococcus senticosus root 1 Contraindicated in acute phase of infections, (PPP, 142, 539) pregnancy, lactation and in cases of known allergy to plants of the Araliaceae family. (WHO2, 91) Commission E noted a contraindication for hypertension. (HM, 107; PPP, 539; TGHM, 125) Two clinical studies recommend that Eleutherococcus not be administered to patients with high blood pressure (HM, 107; TGHM, 62; BSH, 45), although a causal relationship to the use of Eleutherococcus could not be established. (ESCOPM, 142) Caution is advised in cardiovascular disorders. (CGBLH, 195) Insomnia, palpitations, tachycardia and hypertension have been rarely observed in association with clinical studies. (BSH, 45; CGBLH, 195) None known. (HM, 108; TGHM, 125; PPP, 539; ESCOPM, 143) Reports that the herb may increase serum digoxin levels, but not conclusive (PPP, 539) and the identity of the plant material as Eleutherococcus was not established. (WHO2, 91) Refer to the MediHerb Herb-Drug Interactions chart. Euphrasia Complex Contraindicated in pregnancy and lactation. Contraindicated in known allergy to Golden Rod. Eyebright Euphrasia officinalis herb 1 No contraindications noted. (PPP, 376; CGBLH, 203) Golden Rod Solidago virgaurea herb 2d None known. (HM, 180; ESOPM, 1996, 1; TGHM, In chronic kidney disorders, a physician should be 139; CGBLH, 246) consulted. (BSH, 108) Irrigation therapy (copious fluid intake) is contraindicated in case of edema due to impaired heart and kidney function. (HM, 180; TGHM, 139) Contraindicated in known allergy to golden rod. Allergic reactions may occur in susceptible patients sensitized to plants from the Compositae family. (CGBLH, 246) Echinacea Echinacea purpurea root 1 Commission E cautioned that Echinacea pallida root should not be used in systemic diseases such as tuberculosis, leukosis, collagenosis, multiple sclerosis, AIDS, HIV infections, and other autoimmune diseases (based on theoretical considerations and not on any reports of adverse findings). Other authoritative sources do not support these restrictions. (TGHM, 121; PPP, 359-360) Should not be administered to patients with known allergy to any plant of Asteraceae (Compositae). (ESCOPM, 137) Allergic reactions, mainly contact dermatitis, may occur rarely in susceptible patients from Echinacea aerial parts. The likelihood of Echinacea root preparations causing allergy is very low. (CGBLH, 185) None known. (TGHM, 330; PPP, 376; CGBLH, 202) None known. (ESCOPM, 137; PPP, 360) Caution is advised for transplant patients taking immunosuppressive drugs, short-term therapy only is suggested. (PPP, 360; CGBLH, 185) Refer to the MediHerb Herb-Drug Interactions chart. Golden Seal Hydrastis canadensis root & rhizome 2b Contraindicated in hypertensive conditions, pregnancy Berberine, an alkaloid constituent of this herb, may and jaundiced neonates (PPP, 294; CGBLH, 250) Fresh reinforce the effects of other drugs which displace plant may cause irritation to the mucosa. (BSH, 62) the protein binding of bilirubin. (PPP, 295) Canadian regulations do not allow golden seal as a nonmedicinal ingredient for oral use products. (BSH, 62) Cayenne Capsicum annuum fruit 1 When administered in low doses caution is advised in patients with hyperacidity, reflux, inflammatory bowel disorders and chronic nephritis. (PPP, 171) Large doses may cause strong gastrointestinal irritation. (BSH, 23) None known for internal ingestion, (HM, 54; TGHM, 178) although pungent principles may increase absorption rates and metabolism of some pharmacological agents. (PPP, 103) Refer to the MediHerb Herb-Drug Interactions chart. Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 29 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Evening Primrose Oil Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Evening Primrose Oil Oenothera biennis seed 1 None known. (TGHM, 189) Avoid concomitant use May have potential to instigate undiagnosed with phenothiazines. (PPP, 371; WHO2, 226) temporal lobe epilepsy, especially in those receiving phenothiazines, but not conclusive. (PPP, 371) Headache and mild gastrointestinal disturbances have been Refer to the MediHerb Herb-Drug Interactions chart. reported. EPO inhibited plasma platelet factor 4 in one clinical trial. (WHO2, 226) Fe-Max Iron Tonic Phytosynergist® Contraindicated in hemochromatosis and high blood pressure, edema (water retention), congestive heart failure, low blood potassium, pregnancy and lactation. Codonopsis Codonopsis pilosula root 1 None known. (CGBLH, 154) None known. (CGBLH, 154) Nettle Leaf Urtica dioica leaf 1 Contraindication: patients who are allergic to nettle stings should not apply the fresh or unprocessed dried leaves topically. (PPP, 496) Irrigation therapy (copious fluid intake) is not advised if edema exists due to impaired heart or kidney function. (TGHM, 216) Occasional (rare) allergic reactions have been observed. (BHC, 166) None known. (TGHM, 216; ESCOPM, 522; CGBLH, 343) Licorice Glycyrrhiza glabra root 2b, 2c, 2d It is recommended that patients with cardiovascular or renal disease use licorice only under care of health care professional. (TCPHP, 232; PPP, 474) Patients prone to potassium deficiency are also advised not to use licorice. (TCPHP, 232; TGHM, 161) Treatment not to exceed six weeks. (TCPHP, 232; BSH, 58; TGHM, 162) Contraindications: hypertension, cholestatic liver disorders, inflammatory liver disorders, liver cirrhosis, hypertonia, hypokalemia, severe obesity and severe kidney insufficiency (HM, 236; BSH, 58; BHC, 146; TGHM, 161; WHO1, 190; AEHD3, 72; ESCOPM, 298) pregnancy and lactation (ESCOPM, 298). In the case of pregnancy doses up to 3 g per day are likely to be safe. (PPP, 474) Also contraindicated if there is edema or congestive heart failure. (PPP, 474) Caution is advised with elderly patients. (CGBLH, 312) Ingestion of an excessive amount can lead to severe hypertension, cardiac arrhythmias, cardiomyopathy, cardiac arrest, pseudoaldosteronism, myopathy, pulmonary and generalized edema. (AEHD3, 73; BSH, 58; BHC, 146; AEHD3, 72; CGBLH, 313) Should not be taken concurrently with corticosteroid treatment. (WHO1, 190; AEHD3, 77) May decrease plasma clearance and increase the AUC of prednisolone. Licorice may potentiate the activity of prednisolone and other corticosteroid drugs. (ESCOPM, 298; CGBLH, 313) Concurrent use of furosemide may potentiate development of acute renal failure. (AEHD3, 77) Potassium loss due to other drugs, e.g. thiazide diuretics, can be increased. With potassium loss, sensitivity to digitalis glycosides increases. (HM, 237; TGHM, 161; WHO1, 190) Excessive use of licorice may interact with antiarrhythmic drugs or with drugs which induce reversion to sinus rhythm (e.g. quinidine). (ESCOPM, 298) Should not be administered in conjunction with spironolactone or amiloride. (WHO1, 190) Insulin may be synergistic with glycyrrhizin in causing electrolyte disturbances and suppression of renin and aldosterone. (AEHD3, 77) There is a slight chance that licorice may counteract the contraceptive pill, on the basis of the constituent glycyrrhizin. (CGBLH, 312) Refer to the MediHerb Herb-Drug Interactions chart. Ashwaganda Withania somnifera root 2b, 2d High dosages of alkaloids from Withania exhibit prolonged hypotensive, bradycardiac and respiratory stimulant actions, may also have depressant effect on higher cerebral centers; sedative effects have also been demonstrated. (CAACH, 138) None known. (PPP, 601; CGBLH, 73) May potentiate the effects of barbiturates. (BSH, 124) Continues on next page Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 30 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Ginger Zingiber officinale rhizome 2b, 2d Stevia Stevia rebaudiana leaf 1 Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Contraindicated with gallstones; consult a physician first. (HM, 156; BSH, 125; TGHM, 136) May increase the chance of bleeding. (PPP, 401) A daily dose of 2 g of dried ginger should not be exceeded in pregnancy. Use with caution in cases of peptic ulceration, gastroesophageal reflux, or other gastric diseases. At doses approaching or greater than the maximum recommended dose, an increase in gastric secretory activity leading to heartburn is possible. (CGBLH, 227) Overdose may lead to a blood-thinning effect and an increase in gastric secretory activity leading to heartburn. (PPP, 401; ESCOPM, 548) Topical application may cause contact dermatitis in sensitive patients. (PPP, 401) None known. (HM, 156; TGHM, 136) May increase the absorption of pharmaceutical drugs. (PPP, 401) Caution indicated for daily doses of (dried) ginger in excess of 4 g with patients taking blood-thinning drugs such as warfarin, or aspirin or who have increased risk of hemorrhage. (PPP, 401; TCPHP, 129; CAACH, 106; CGBLH, 227) May enhance absorption of sulphaguanidine. (ESCOPM, 548) None known. (BSH, 110) No information. Refer to the MediHerb Herb-Drug Interactions chart. Feverfew Contraindicated in individuals with a known hypersensitivity to Feverfew, parthenolide or other members of the daisy family. Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Feverfew Tanacetum parthenium leaf & stem 2b Contraindication: pregnancy. Occasional mouth ulceration and gastric disturbances have been reported, but the incidence is low. Contact allergy is known but rare. No major adverse effects with long-term use have been recorded. (BHC, 97) Contraindicated in those with known hypersensitivity to either feverfew, parthenolide or other members of the Compositae family. (PPP, 391; WHO2, 324; CGBLH, 219) None known. (ESCOPM, 493; PPP, 391; CGBLH, 219) In vitro studies suggest that feverfew may inhibit platelet aggregation (TCPHP, 102), however, results from clinical trials suggest that normal clotting mechanisms remain intact. (PPP, 387) Ganoderma & Shiitake Contraindicated in cases of known allergy to Shiitake. Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Shiitake Lentinula edodes mushroom 1 No information. No information. Reishi Ganoderma lucidum mushroom 1 Rare side effects (dryness of the mouth, throat, and nasal area; itchiness; stomach upset; nosebleed; bloody stools) have been recorded after 3 to 6 months of continuous use. One instance of skin rash was observed following consumption of Reishi wine. (BSH, 55) No information. Garlic 5000mg Contraindicated in known allergy to Garlic. Contraindicated in lactation. Not to be used during pregnancy unless otherwise directed by a qualified health care professional. Garlic Allium sativum bulb Note: 2c Contraindication with gastrointestinal disturbance; in rare instances, there may be changes to the flora of the intestine, or allergic reactions. (TGHM, 134; HM, 145; BSH, 6; BHC, 106) Fresh garlic, extracts or oil may also cause heartburn, nausea, vomiting, and diarrhea if taken on an empty stomach. (WHO1, 26) Garlic intake should be discontinued 10 days before surgery. (PPP, 200) May increase the risk of postoperative bleeding. (WHO1, 25; ESCOPM, 15; AEHD3, 229) Contact allergy is noted. (AEHD1, 74; WHO1, 26) Hematologic concern based upon in vitro data and case reports for garlic and garlic oil. [Editor’s note: the results of case reports are conflicting.] (TCPHP, 110, 111, 301) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 None known. (TGHM, 134) Garlic’s antiplatelet effect might be dangerous in patients taking warfarin or antiplatelet agents such as aspirin, ticlopidine, clopidogrel, or dipyridamole. (TCPHP, 118; HM, 115; WHO1, 25) An interaction has been observed in two patients taking warfarin. (ESCOPM, 15) Refer to the MediHerb Herb-Drug Interactions chart. The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 31 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Ginkgo 2000mg Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Ginkgo Ginkgo biloba leaf 2d Adverse reactions: headaches, mild gastrointestinal disturbances, and allergic skin reactions are possible. (WHO1, 163; PPP, 414; TGHM, 138; HM, 166; AEHD3, 59; BSH, 57; ESCOPM, 179) Contraindicated in hypersensitivity or intolerance to Ginkgo preparations. (TGHM, 137; WHO1, 162; ESCOPM, 179) Hematologic and neurologic concern based on case reports. (TCPHP, 301) Isolated episodes of spontaneous bleeding have been reported. (CGBLH, 233) None known. (TGHM, 138; WHO1, 163) Caution should be exercised when prescribing Ginkgo with warfarin or aspirin. (PPP, 414; HM, 167) (Although no interactions with substances that inhibit blood coagulation have been observed in controlled studies. (ESCOPM, 179)) The effect of plateletaggregation inhibitors may be increased. (HM, 167) Refer to the MediHerb Herb-Drug Interactions chart. Golden Seal 500mg Contraindicated in pregnancy, lactation and patients with high blood pressure. Golden Seal Hydrastis canadensis root & rhizome 2b Contraindicated in hypertensive conditions, pregnancy Berberine, an alkaloid constituent of this herb, may and jaundiced neonates (PPP, 294; CGBLH, 250) Fresh reinforce the effects of other drugs which displace plant may cause irritation to the mucosa. (BSH, 62) the protein binding of bilirubin. (PPP, 295) Canadian regulations do not allow golden seal as a nonmedicinal ingredient for oral use products. (BSH, 62) Gotu Kola Complex Contraindicated in known allergy to Gotu Kola. Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Gotu Kola Centella asiatica herb 1 Grape Seed Vitis vinifera seed No information. No information. None known. (WHO1, 83; CGBLH, 254) Canadian regulations do not allow the herb as a nonmedicinal ingredient for oral use products. (BSH, 26) Allergic contact dermatitis has been associated with topical application, but it is a low risk. Further testing revealed that these reactions may be due to other ingredients in the preparations. (WHO1, 83; CGBLH, 255) Contraindicated in known allergy and allergy to plants of the Umbelliferae (carrot) family. (WHO1, 82; CGBLH, 254) No information. Refer to the MediHerb Herb-Drug Interactions chart (under Tannin- or OPC-containing herbs). Ginkgo Ginkgo biloba leaf Note: 2d Adverse reactions: headaches, mild gastrointestinal disturbances, and allergic skin reactions are possible. (WHO1, 163; PPP, 414; TGHM, 138; HM, 166; AEHD3, 59; BSH, 57; ESCOPM, 179) Contraindicated in hypersensitivity or intolerance to Ginkgo preparations. (TGHM, 137; WHO1, 162; ESCOPM, 179) Hematologic and neurologic concern based on case reports. (TCPHP, 301) Isolated episodes of spontaneous bleeding have been reported. (CGBLH, 233) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 None known. (TGHM, 138; WHO1, 163) Caution should be exercised when prescribing Ginkgo with warfarin or aspirin. (PPP, 414; HM, 167) (Although no interactions with substances that inhibit blood coagulation have been observed in controlled studies. (ESCOPM, 179)) The effect of plateletaggregation inhibitors may be increased. (HM, 167) Refer to the MediHerb Herb-Drug Interactions chart. The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 32 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Gut Flora Complex Contraindicated in pregnancy and lactation. Contraindicated in patients taking anticoagulant drugs. Anise Pimpinella anisum fruit essential oil No information. Avoid in those with sensitivity to anethole. Preparations At an oral daily dose of 0.5 mL or above: use with caution in those taking acetominophen. (EOS, containing the essential oil should not be used during 113-114, 117) pregnancy and lactation. (ESCOPM, 37) [Editor’s note: This information is based on a caution in humans at an oral daily dose of 0.5 mL or above of the essential oil and antifertility effects demonstrated in an animal study using very high doses (50–80 mg/kg of the constituent anethole, about 870–1400 mg/kg for the best quality essential oil).] At an oral daily dose of 0.5 mL or above: use with caution in alcoholism, estrogen-dependent cancers, liver disease, endometriosis. (EOS, 113-114, 117) Pau d’Arco Tabebuia avellanedae stem 1 Contraindicated with anticoagulants. (PPP, 504) Adverse effects are not expected when consumed with the recommended dosage. (PPP, 500) Caution is advised in pregnancy. (CGBLH, 366) Patients on anticoagulant therapy should not be prescribed pau d’arco due to the warfarin-like action of naphthoquinones at high doses. (PPP, 504) Refer to the MediHerb Herb-Drug Interactions chart. Andrographis Andrographis paniculata herb 2b Oregano Origanum vulgare leaf essential oil No information. None known for an oral daily dose of 0.5 mL or above. (EOS, 113-114, 156) Contraindication: pregnancy, (BSH, 9; CAACH, 100; CGBLH, 65) lactation; known allergy to plants of the Acanthaceae family. (WHO2, 20) High doses may cause gastric discomfort, loss of appetite and vomiting, but generally there are few side effects and it is non-toxic. (CAACH, 99) Two cases of urticaria have been reported. (WHO2, 21; CGBLH, 65) None known. (PPP, 266; CGBLH, 65) No information. Gymnema 4g Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Gymnema Gymnema sylvestre leaf No information. Since it contains saponins, this herb may be a gastrointestinal irritant. (PPP, 46) None known. (CGBLH, 267) [Editor's note: Particular care should be exercised where the patient is taking insulin or oral hypoglycemic drugs.] Refer to the MediHerb Herb-Drug Interactions chart (under Hypoglycemic herbs). Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 33 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Hawthorn Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Hawthorn Crataegus monogyna herb flowering top 1 Occasional side effects include gastrointestinal disorders, palpitation, headache, dizziness, circulatory disturbances, sleeplessness and inner agitation. (CGBLH, 270) A physician must be consulted in cases where symptoms continue unchanged for longer than six weeks or when fluid accumulates in the legs. Medical diagnosis is absolutely necessary when pains occur in the region of the heart, spreading out to the arms, upper abdomen or the area around the neck, or in cases of respiratory distress (shortness of breath). (TGHM, 143; ESCOPM, 99; WHO2, 77) In 1997, it was noted that in Canada, the herb carries new drug status and is not approved, as self-treatment of cardiovascular conditions is deemed inappropriate. (TCPHP, 257) Hawthorn preparations may have a potentiating effect which may necessitate a smaller dosage of digitalis,(PPP, 446; BSH, 37) though this action has not been confirmed. (HM, 186) Hawthorn preparations may act in synergy with beta-blockers and other hypotensive drugs. Modification of drug dosage may be required. (PPP, 446; CGBLH, 270; TCPHP, 257) Refer to the MediHerb Herb-Drug Interactions chart (under Hawthorn and Tannin- or OPC-containing herbs). Herbal Throat Spray Phytosynergist® Contraindicated in known allergy to plants of the daisy family, and allergy to clove or eugenol. Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Marshmallow Root Althaea officinalis root 1 As a mucilage or respiratory demulcent, contraindicated Absorption of other drugs taken simultaneously may or at least inappropriate in congestive bronchial, be delayed. (BSH, 9; HM, 245, 247; ESCOPM, 33; catarrhal and congestive conditions of the mucosa. (PPP, TGHM, 166, 167; WHO2, 9; CGBLH, 321) 169, 211) Refer to the MediHerb Herb-Drug Interactions chart. Sage Salvia officinalis herb 2b, 2d Leaf and essential oil are contraindicated in pregnancy and lactation. (CGBLH, 394; TGHM, 198) After prolonged ingestion of alcohol extracts or of the pure essential oil, epileptiform convulsions can occur. (HM, 332; TGHM, 198) Caution is advised with the use of alcoholic preparations and the pure essential oil because of the presence of thujone. (ESCOPM, 453; HM, 332; TGHM, 198) Do not exceed the recommended dose, take with caution if using long term. (CGBLH, 394) Calendula Calendula officinalis flower No information. Inappropriate when there is already prescription of strong anti-inflammatory medication, (PPP, 148) and for those with known sensitivity to members of the Compositae family. (ESCOPM, 59; WHO2, 41; CGBLH, 120) Weak skin sensitization and a case of anaphylactic shock has been reported from topical use (a gargle). (CGBLH, 120) None known. (HM, 332; ESCOPM, 453; TGHM, 198; BSH, 102; CGBLH, 394) Refer to the MediHerb Herb-Drug Interactions chart (under Tannin- or OPC-containing herbs). None known. (HM, 45; ESCOPM, 59; TGHM, 100, 319; CGBLH, 120) Continues on next page Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 34 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Echinacea Echinacea angustifolia root 1 Contraindications, Cautions and Potential Adverse Reactions Commission E cautioned that Echinacea pallida root and E. angustifolia herb and root should not be used in systemic diseases such as tuberculosis, leukosis, collagenosis, multiple sclerosis, AIDS, HIV infections, and other autoimmune diseases (based on theoretical considerations and not on any reports of adverse findings). Other authoritative sources do not support these restrictions. (HM, 94; TGHM, 121, 328; PPP, 359-360) Allergic reactions, mainly contact dermatitis, may occur rarely in susceptible patients from Echinacea aerial parts. The likelihood of Echinacea root preparations causing allergy is very low. (CGBLH, 185) Interactions with Drugs None known. (HM, 95; PPP, 360) Caution is advised for transplant patients taking immunosuppressive drugs, short-term therapy only is suggested. (PPP, 360; CGBLH, 185) Refer to the MediHerb Herb-Drug Interactions chart. Myrrh Commiphora molmol resin 2b, 2d Clove Syzygium aromaticum bud essential oil No information. Oil of clove may be irritating to mucosal tissues. (TGHM, At an oral daily dose of 0.5 mL or above: use 112) with caution in those taking anticoagulants or acetominophen. (EOS, 113-114, 131) At an oral daily dose of 0.5 mL or above: use with caution in alcoholism, hemophilia, kidney disease, liver disease, prostate cancer, systemic lupus erythematosus. (EOS, 113-114, 131) Contraindicated in pregnancy, excessive uterine bleeding None known. (CGBLH, 335) and known allergy. Allergic contact dermatitis has been reported. Not to be ingested for prolonged periods (> few weeks). (CGBLH, 335) HiPep Contraindicated in known allergy to plants of the daisy family. Meadowsweet should be avoided by persons hypersensitive to salicylates. Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Deglycyrrhizinized Licorice Glycyrrhiza glabra root No information. Deglycyrrhizinized licorice is usually free of adverse effects. (BSH, 58; BHC, 146) Co-administered deglycyrrhizinized licorice increased the bioavailability of nitrofurantoin.(AEHD3, 77) Refer to the MediHerb Herb-Drug Interactions chart. Chamomile Matricaria recutita flower Meadowsweet Filipendula ulmaria herb 1 1 Contraindicated in known allergy to chamomile or other members of the Compositae family. (CGBLH, 137) May cause rare contact allergy. (BHC, 155) Allergic concern based upon case reports. (TCPHP, 301) Highly concentrated hot tea is noted as emetic. (BSH, 74) German Standard License requires the following label: “The infusion should not be used near the eyes.” (BSH, 74) The pollen contained in these infusions appears to be responsible for the allergic reaction. (CGBLH, 138) None known. (TGHM, 107; HM, 60; BHC, 155) Avoid concomitant administration of chamomile during iron intake. In anemia and cases for which iron supplementation is required, chamomile should not be taken simultaneously with meals or iron supplements. (CGBLH, 137-138) Contraindicated in cases of hypersensitivity to salicylates.(ESCOPM, 158) None known. (TGHM, 169; HM, 254; ESCOPM, 158) With the experimental anticoagulant effect of this herb, caution should be used if patients are taking warfarin, (PPP, 481; CGBLH, 324) although the level of salicylate derivatives makes interaction with anticoagulant agents unlikely. (ESCOPM, 158) Refer to the MediHerb Herb-Drug Interactions chart (under Polyphenolic- or Flavonoid-containing herbs). Refer to the MediHerb Herb-Drug Interactions chart (under Meadowsweet and Tannin- or OPCcontaining herbs). Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 35 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Horsechestnut Complex Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Butcher’s Broom Ruscus aculeatus root & rhizome 1 Horsechestnut Aesculus hippocastanum seed No information. Contraindicated in known allergy to plants of the Hippocastanaceae family. (WHO2, 144) Adverse effects reported to include pruritis, nausea, and gastric complaints in isolated cases after oral intake. (HM, 203; ESCOPM, 249; WHO2, 145) Oral use may cause irritation of the gastric mucous membranes and reflux. Saponins may cause hemolysis, but this effect is negligible at the oral doses commonly used. (PPP, 454) Horsechestnut should not be applied to broken or ulcerated skin. (PPP, 454) Allergic reactions have been reported from topical use of the active constituent escin. (WHO2, 145) None known. (HM, 203; PPP, 454; ESCOPM, 249; CGBLH, 281) Ginkgo Ginkgo biloba leaf 2d None known. (TGHM, 138; WHO1, 163) Caution should be exercised when prescribing Ginkgo with warfarin or aspirin. (PPP, 414; HM, 167) (Although no interactions with substances that inhibit blood coagulation have been observed in controlled studies. (ESCOPM, 179)) The effect of plateletaggregation inhibitors may be increased. (HM, 167) None known. (ESCOPM, 438) In rare cases, gastric disorders or nausea may occur. (HM, 41; TGHM, 99) Adverse reactions: headaches, mild gastrointestinal disturbances, and allergic skin reactions are possible. (WHO1, 163; PPP, 414; TGHM, 138; HM, 166; AEHD3, 59; BSH, 57; ESCOPM, 179) Contraindicated in hypersensitivity or intolerance to Ginkgo preparations. (TGHM, 137; WHO1, 162; ESCOPM, 179) Hematologic and neurologic concern based on case reports. (TCPHP, 301) Isolated episodes of spontaneous bleeding have been reported. (CGBLH, 233) None known. (HM, 41; TGHM, 99; ESCOPM, 438) Refer to the MediHerb Herb-Drug Interactions chart. LivCo ® Contraindicated in pregnancy. Contraindicated during lactation unless otherwise directed by a qualified health care professional. In anemia and cases where iron supplementation, do not take simultaneously with meals or iron supplements. Schisandra Schisandra chinensis fruit Rosemary Rosmarinus officinalis leaf 1 2b Contraindicated in pregnancy, except to assist childbirth; in the early stages of cough or rash and in excess heat patterns. (CGBLH, 405) May be contraindicated in liver carcinoma. (PPP, 192) Rare side effects of appetite suppression, stomach upset, and urticaria are reported. (BSH, 104) None known. (CGBLH, 405) Contraindications: pregnancy (PPP, 100) and hypersensitivity to rosemary leaf and rosemary preparations, especially those containing carnosol. (ESCOPM, 430) Caution may be warranted in women wishing to conceive. (CGBLH, 389) None known. (HM, 327; TGHM, 197; ESCOPM, 430) Avoid concomitant administration of rosemary during iron intake. In anemia and cases for which iron supplementation is required, rosemary should not be taken simultaneously with meals or iron supplements. (CGBLH, 389) Refer to the MediHerb Herb-Drug Interactions chart. Refer to the MediHerb Herb-Drug Interactions chart (under Polyphenolic- or Flavonoid-containing herbs). Milk Thistle Silybum marianum seed Note: 1 Contraindicated in cases of known allergy to plants of the Asteraceae (Compositae) family. (WHO2, 310) Side effect: a mild laxative effect and mild gastrointestinal complaints have been observed in occasional instances from the standardized preparation. (HM, 260; TGHM, 170; WHO2, 310; CGBLH, 326) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 None known. (PPP, 560; HM, 261; TGHM, 170) Refer to the MediHerb Herb-Drug Interactions chart (under Milk Thistle and Polyphenolic- or Flavonoidcontaining herbs). The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 36 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Livton® Complex Contraindicated in pregnancy. Contraindicated during lactation unless otherwise directed by a qualified health care professional. Contraindicated in closure of the gallbladder. In anemia and cases where iron supplementation, do not take simultaneously with meals or iron supplements. Use only with professional supervision in gallstones. Globe Artichoke Cynara scolymus leaf No information. Contraindicated in closure of the gallbladder (PPP, 437) None known. (PPP, 437; TGHM, 85; HM, 11; ESCOPM, or obstruction of bile duct. (ESCOPM, 119). Precautions 119; CGBLH, 240) with known allergies to artichoke and similar plants (Compositae family). The likelihood of allergy is very low, no cases of allergy reaction after oral intake have been reported. (TGHM, 84; HM, 11; ESCOPM, 119; CGBLH, 240) Use only with professional supervision in cholelithiasis. (PPP, 437; HM, 11; ESCOPM, 119) As with other members of the Compositae family, contact with fresh plant can cause contact dermatitis. (PPP, 438) Mild gastrointestinal disturbances may occur in rare cases; allergic reactions might occur in sensitized patients. (ESCOPM, 119) Dandelion Root Taraxacum officinale root None known. (TGHM, 119; HM, 80, 81; ESCOPM, No information. Contraindicated or at least inappropriate in the 503; CGBLH, 173) following: (1) obstructed bile ducts, (2) unconjugated hyperbilirubinemia, (3) acute or severe hepatocellular disease, (4) septic cholecystitis (where there is risk of peritonitis), (5) intestinal spasm or ileus, (6) liver cancer and (7) gall bladder empyema. (PPP, 187; BHC, 73, 76; ESCOPM, 503; BSH, 114) In case of gallstones, first consult a physician. (HM, 80, 81) May cause superacidic stomach problems. (BSH, 114) Milk Thistle Silybum marianum seed 1 Contraindicated in cases of known allergy to plants of the Asteraceae (Compositae) family. (WHO2, 310) Side effect: a mild laxative effect and mild gastrointestinal complaints have been observed in occasional instances from the standardized preparation. (HM, 260; TGHM, 170; WHO2, 310; CGBLH, 326) None known. (PPP, 560; HM, 261; TGHM, 170) Refer to the MediHerb Herb-Drug Interactions chart (under Milk Thistle and Polyphenolic- or Flavonoidcontaining herbs). Bupleurum Bupleurum falcatum root 1 Contraindicated in deficient yin cough, or liver fire ascending to the head, such as some cases of headache and hypertension. (CGBLH, 116) Bupleurum has a slight sedative effect in some patients and may also increase bowel movements and flatulence (wind). (CAACH, 23; WHO1, 73, 74; PPP, 317) May cause nausea and reflux in sensitive patients. (PPP, 317) The use of alcohol, sedatives and other central nervous system depressants, in conjunction with this herb, may cause synergistic sedative effects. (WHO1, 73) Fringe Tree Chionanthus virginicus stem bark 1 The herb is classified as a choleretic and cholagogue. It is either contraindicated or at least inappropriate in the following: (1) obstructed bile ducts, (2) unconjugated hyperbilirubinemia, (3) acute or severe hepatocellular disease, (4) septic cholecystitis (where there is risk of peritonitis), (5) intestinal spasm or ileus, and (6) liver cancer. (PPP, 187) None known. (CGBLH, 222) Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 37 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Nevaton® Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Do not use this product while taking any prescription drug(s) without the advice of your prescribing physician. Avoid excessive exposure to UV irradiation (e.g. sunlight, tanning) when using this product. Schisandra Schisandra chinensis fruit 1 Contraindicated in pregnancy, except to assist childbirth; in the early stages of cough or rash and in excess heat patterns. (CGBLH, 405) May be contraindicated in liver carcinoma. (PPP, 192) Rare side effects of appetite suppression, stomach upset, and urticaria are reported. (BSH, 104) None known. (CGBLH, 405) None known. (TGHM, 326; CGBLH, 171) Refer to the MediHerb Herb-Drug Interactions chart. Damiana Turnera diffusa leaf 1 Possible contraindication in patients with extremely debilitated constitutions. (PPP, 234) Skullcap Scutellaria lateriflora herb 1 None known. (CGBLH, 415) May be contraindicated in depression and insomnia marked by increasing restlessness during the early hours of the morning. (PPP, 233) High doses may cause giddiness, stupor, confusion, twitching, arrhythmias, and epilepsy. (TCPHP, 218) Reports of toxicity are likely due to adulteration with germander. (BSH, 105) St John’s Wort Hypericum perforatum herb flowering top 2d Contraindicated in the treatment of serious depression with psychotic symptoms, suicidal risk or signs and symptoms that are so severe that they do not allow the patient’s family or work involvements to continue. (PPP, 549; ESCOPM, 259) Not to be taken after organ transplants. (ESCOPM, 258) Contraindicated in known photosensitivity and known allergy to plants of the Clusiaceae family. (WHO2, 163; CGBLH, 420) May cause mild stomach discomfort, skin rash, tiredness, fatigue, headache, sleep disturbances. Photosensitization is possible after exposure to sunlight and especially in fair skinned individuals. (BSH, 62; TGHM, 215; HM, 363; PPP, 548; ESCOPM, 259; WHO2, 163) Patients taking higher doses should avoid excessive exposure to sunlight and UV radiation. (CGBLH, 420) Caution advised in very severe debility, especially if associated with immune or digestive collapse, renal or hepatic failure, rampant cancer or strong regimes of chemotherapy. (PPP, 155) Dermatologic and neurologic concern based upon case reports. (TCPHP, 301) Side effects are rare and mild, and include minor gastrointestinal irritations, allergic reactions, tiredness and restlessness. (WHO2, 165) Mild, reversible elevations of serum liver enzymes noted in HIV-positive patients. Mania has been noted as a side effect but has not been conclusively linked to use of the herb. Avoid use of preparations made from herb harvested at the onset of full flowering, and avoid dispensing the sediment from liquid extracts – the resinous compounds contained therein may cause sensory nerve hypersensitivity. (CGBLH, 422) Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 None known. (TGHM, 215; HM, 363) May potentiate pharmaceutical MAO-inhibitors. (BSH, 62, 173) Recommend physician consultation when taken with MAO inhibitors, SSRIs, and tricyclics (PPP, 549) Reduced blood levels have been reported with respect to cyclosporin, indinavir and potentially other antiretroviral protease and transcriptase inhibitors, the anticoagulants phenprocoumon and warfarin, theophylline and digoxin. It remains an open question whether St John’s wort preparations also interact with oral contraceptives, particularly low dose contraceptives (<50 mcg of estrogen). (ESCOPM, 259) Contraindicated in patients taking irinotecan. No clinical adverse effects have been reported for phenytoin or any other anticonvulsant drug. (CGBLH, 421) Refer to the MediHerb Herb-Drug Interactions chart (under St John’s Wort and Tannin- or OPC-containing herbs). The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 38 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs ProstaCo Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. The National Institute on Aging recommends that men get regular medical checkups with a thorough prostate exam. Nettle Root Urtica dioica root None known. (TGHM, 217; ESCOPM, 529) No information. Contraindicated in known allergy to plants of the Urticaceae family. (WHO2, 337) Commission E advises that nettle root is useful for the problems associated with an enlarged prostate. However, they advise that its use for BPH should occur under professional supervision. (PPP, 496) Difficulties in micturition require at all times clarification by a physician; consultation with a physician is necessary especially in cases blood in the urine and acute urine retention. (ESCOPM, 529) May cause mild gastrointestinal trouble and allergic skin reactions (rarely). (PPP, 496; TGHM, 216; ESCOPM, 529; WHO2, 338) Saw Palmetto Serenoa repens fruit 1 Crataeva Crataeva nurvala stem bark No information. None known. (CGBLH, 168) None known. (HM, 338; TGHM, 201; PPP, 530; Stomach problems or gastrointestinal distress in rare ESCOPM, 478; CGBLH, 400) cases. (HM, 338; TGHM, 201; BSH, 107; ESCOPM, 478) Commission E suggests regular consultation with a physician when using this herb for treatment of enlarged prostate. This caution is based on assumption that this herb treats only symptoms without eliminating hypertrophic concerns. (BSH, 107) No adverse effects are expected if used as recommended. (PPP, 524) None known. (CGBLH, 168) PulmaCo Contraindicated in pregnancy and lactation. Chinese Skullcap Scutellaria baicalensis root 1 Malabar Nut Tree Adhatoda vasica leaf No information. Contraindicated in pregnancy except at birth. Unlikely that abortifacient doses can be achieved by oral use of the herb, but it is best to be cautious. (CAACH, 93) No information. Grindelia Grindelia camporum herb No information. High doses can produce kidney and stomach irritation. (BSH, 59) None known. (CGBLH, 224) Turmeric Curcuma longa rhizome 2b, 2d None known. (HM, 382; TGHM, 222; ESCOPM, 108) High doses (>15 g/day) should not be given to patients taking antiplatelet or anticoagulant drugs. (PPP, 578; CGBLH, 436) Traditionally contraindicated in cold conditions. (CGBLH, 83) Gastric discomfort occurs rarely. (AEHD2, 291) Contraindicated in obstruction of bile passages; in case of gallstones, use only after consulting with a physician. (TGHM, 222; HM, 382; WHO1, 121; PPP, 578; ESCOPM, 107) The herb should not be administered to patients who suffer from stomach ulcers or hyperacidity. (BSH, 39; HM, 382) Occasional cases of allergic dermatitis reported. (WHO1, 121; PPP, 578) Care should be exercised with women wishing to conceive and patients complaining of hair loss. (CGBLH, 436) Patients applying topical doses should be cautioned against excessive exposure to sunlight. (PPP, 578) None known. (CGBLH, 83) Refer to the MediHerb Herb-Drug Interactions chart. Continues on next page Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 39 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Ginkgo Ginkgo biloba leaf 2d Fennel Foeniculum vulgare seed essential oil Contraindications, Cautions and Potential Adverse Reactions Adverse reactions: headaches, mild gastrointestinal disturbances, and allergic skin reactions are possible. (WHO1, 163; PPP, 414; TGHM, 138; HM, 166; AEHD3, 59; BSH, 57; ESCOPM, 179) Contraindicated in hypersensitivity or intolerance to Ginkgo preparations. (TGHM, 137; WHO1, 162; ESCOPM, 179) Hematologic and neurologic concern based on case reports. (TCPHP, 301) Isolated episodes of spontaneous bleeding have been reported. (CGBLH, 233) No information. In rare cases, allergic reactions affecting skin and respiratory system. (HM, 126; TGHM, 128) Avoid in those with sensitivity to anethole. Preparations containing the essential oil should not be used during pregnancy and lactation. (ESCOPM, 163) High doses (greater than 0.1–0.6 mL/day) are contraindicated in pregnancy, infants and toddlers. (TGHM, 128) Very high doses should be avoided in hepatic disorders. (Normal recommended daily dosage: 5–20 drops.) (PPP, 382) Should not be taken at an oral daily dose of 0.5 mL or above. (EOS, 113-114, 136) Interactions with Drugs None known. (TGHM, 138; WHO1, 163) Caution should be exercised when prescribing Ginkgo with warfarin or aspirin. (PPP, 414; HM, 167) (Although no interactions with substances that inhibit blood coagulation have been observed in controlled studies. (ESCOPM, 179)) The effect of plateletaggregation inhibitors may be increased. (HM, 167) Refer to the MediHerb Herb-Drug Interactions chart. Interaction between fennel oil and drugs in humans is not known. (TGHM, 128; HM, 126; PPP, 382; AEDH1,138) Rehmannia Complex Contraindicated in individuals with a known hypersensitivity to Feverfew, parthenolide or other members of the daisy family. Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Bupleurum Bupleurum falcatum root 1 Contraindicated in deficient yin cough, or liver fire ascending to the head, such as some cases of headache and hypertension. (CGBLH, 116) Bupleurum has a slight sedative effect in some patients and may also increase bowel movements and flatulence (wind). (CAACH, 23; WHO1, 73, 74; PPP, 317) May cause nausea and reflux in sensitive patients. (PPP, 317) Rehmannia Rehmannia glutinosa root 2d Contraindicated with diarrhea and indigestion. (BSH, 95) None known. (PPP, 521; CGBLH, 386) Side effects may include mild diarrhea, abdominal pain, dizziness, lack of energy, palpitations and edema. (BSH, 95; PPP, 521) Hemidesmus Hemidesmus indicus root 4 Although mildly immunosuppressant, there are no reported side effects. (CAACH, 118) None known. (CGBLH, 275) Feverfew Tanacetum parthenium leaf & stem 2b Contraindication: pregnancy. Occasional mouth ulceration and gastric disturbances have been reported, but the incidence is low. Contact allergy is known but rare. No major adverse effects with long-term use have been recorded. (BHC, 97) Contraindicated in those with known hypersensitivity to either feverfew, parthenolide or other members of the Compositae family. (PPP, 391; WHO2, 324; CGBLH, 219) None known. (ESCOPM, 493; PPP, 391; CGBLH, 219) In vitro studies suggest that feverfew may inhibit platelet aggregation (TCPHP, 102), however, results from clinical trials suggest that normal clotting mechanisms remain intact. (PPP, 387) Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 The use of alcohol, sedatives and other central nervous system depressants, in conjunction with this herb, may cause synergistic sedative effects. (WHO1, 73) The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 40 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs ResCo® Contraindicated in high blood pressure, edema (water retention), congestive heart failure, low blood potassium, pregnancy and lactation. Licorice Glycyrrhiza glabra root 2b, 2c, 2d It is recommended that patients with cardiovascular or renal disease use licorice only under care of health care professional. (TCPHP, 232; PPP, 474) Patients prone to potassium deficiency are also advised not to use licorice. (TCPHP, 232; TGHM, 161) Treatment not to exceed six weeks. (TCPHP, 232; BSH, 58; TGHM, 162) Contraindications: hypertension, cholestatic liver disorders, inflammatory liver disorders, liver cirrhosis, hypertonia, hypokalemia, severe obesity and severe kidney insufficiency (HM, 236; BSH, 58; BHC, 146; TGHM, 161; WHO1, 190; AEHD3, 72; ESCOPM, 298) pregnancy and lactation (ESCOPM, 298). In the case of pregnancy doses up to 3 g per day are likely to be safe. (PPP, 474) Also contraindicated if there is edema or congestive heart failure. (PPP, 474) Caution is advised with elderly patients. (CGBLH, 312) Ingestion of an excessive amount can lead to severe hypertension, cardiac arrhythmias, cardiomyopathy, cardiac arrest, pseudoaldosteronism, myopathy, pulmonary and generalized edema. (AEHD3, 73; BSH, 58; BHC, 146; AEHD3, 72; CGBLH, 313) Mullein Verbascum thapsus leaf 1 None known. (CGBLH, 333) None known. (HM, 271; TGHM, 173; CGBLH, 333) Euphorbia Euphorbia hirta herb 2d Large doses may cause nausea and vomiting, and it may occasionally cause epigastric distress with nausea. (CGBLH, 199) None known. (CGBLH, 199) Grindelia Grindelia camporum herb No information. High doses can produce kidney and stomach irritation. (BSH, 59) None known. (CGBLH, 224) Ginger Zingiber officinale rhizome 2b, 2d None known. (HM, 156; TGHM, 136) May increase the absorption of pharmaceutical drugs. (PPP, 401) Caution indicated for daily doses of (dried) ginger in excess of 4 g with patients taking blood-thinning drugs such as warfarin, or aspirin or who have increased risk of hemorrhage. (PPP, 401; TCPHP, 129; CAACH, 106; CGBLH, 227) May enhance absorption of sulphaguanidine. (ESCOPM, 548) Should not be taken concurrently with corticosteroid treatment. (WHO1, 190; AEHD3, 77) May decrease plasma clearance and increase the AUC of prednisolone. Licorice may potentiate the activity of prednisolone and other corticosteroid drugs. (ESCOPM, 298; CGBLH, 313) Concurrent use of furosemide may potentiate development of acute renal failure. (AEHD3, 77) Potassium loss due to other drugs, e.g. thiazide diuretics, can be increased. With potassium loss, sensitivity to digitalis glycosides increases. (HM, 237; TGHM, 161; WHO1, 190) Excessive use of licorice may interact with antiarrhythmic drugs or with drugs which induce reversion to sinus rhythm (e.g. quinidine). (ESCOPM, 298) Should not be administered in conjunction with spironolactone or amiloride. (WHO1, 190) Insulin may be synergistic with glycyrrhizin in causing electrolyte disturbances and suppression of renin and aldosterone. (AEHD3, 77) There is a slight chance that licorice may counteract the contraceptive pill, on the basis of the constituent glycyrrhizin. (CGBLH, 312) Refer to the MediHerb Herb-Drug Interactions chart. Contraindicated with gallstones; consult a physician first. (HM, 156; BSH, 125; TGHM, 136) May increase the chance of bleeding. (PPP, 401) A daily dose of 2 g of dried ginger should not be exceeded in pregnancy. Use with caution in cases of peptic ulceration, gastroesophageal reflux, or other gastric diseases. At doses approaching or greater than the maximum recommended dose, an increase in gastric secretory activity leading to heartburn is possible. (CGBLH, 227) Overdose may lead to a blood-thinning effect and an increase in gastric secretory activity leading to heartburn. (PPP, 401; ESCOPM, 548) Topical application may cause contact dermatitis in sensitive patients. (PPP, 401) Refer to the MediHerb Herb-Drug Interactions chart. Continues on next page Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 41 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Product and Ingredient Name Class Fennel Foeniculum vulgare fruit essential oil No information. In rare cases, allergic reactions affecting skin and respiratory system. (HM, 126; TGHM, 128) Avoid in those with sensitivity to anethole. Preparations containing the essential oil should not be used during pregnancy and lactation. (ESCOPM, 163) High doses (greater than 0.1–0.6 mL/day) are contraindicated in pregnancy, infants and toddlers. (TGHM, 128) Very high doses should be avoided in hepatic disorders. (Normal recommended daily dosage: 5–20 drops.) (PPP, 382) Should not be taken at an oral daily dose of 0.5 mL or above. (EOS, 113-114, 136) Interaction between fennel oil and drugs in humans is not known. (TGHM, 128; HM, 126; PPP, 382; AEDH1,138) Thyme Thymus vulgaris leaf essential oil No information. None known for an oral daily dose of 0.5 mL or above. (EOS, 113-114, 176) Substantial doses should be avoided in pregnancy. (BSH, 116) No information. ResCo Phytosynergist® Contraindicated in high blood pressure, edema (water retention), congestive heart failure, low blood potassium, pregnancy and lactation. Contraindicated in known allergy to Elecampane. Mullein Verbascum thapsus leaf 1 None known. (CGBLH, 333) None known. (HM, 271; TGHM, 173; CGBLH, 333) Licorice Glycyrrhiza glabra root 2b, 2c, 2d It is recommended that patients with cardiovascular or renal disease use licorice only under care of health care professional. (TCPHP, 232; PPP, 474) Patients prone to potassium deficiency are also advised not to use licorice. (TCPHP, 232; TGHM, 161) Treatment not to exceed six weeks. (TCPHP, 232; BSH, 58; TGHM, 162) Contraindications: hypertension, cholestatic liver disorders, inflammatory liver disorders, liver cirrhosis, hypertonia, hypokalemia, severe obesity and severe kidney insufficiency (HM, 236; BSH, 58; BHC, 146; TGHM, 161; WHO1, 190; AEHD3, 72; ESCOPM, 298) pregnancy and lactation (ESCOPM, 298). In the case of pregnancy doses up to 3 g per day are likely to be safe. (PPP, 474) Also contraindicated if there is edema or congestive heart failure. (PPP, 474) Caution is advised with elderly patients. (CGBLH, 312) Ingestion of an excessive amount can lead to severe hypertension, cardiac arrhythmias, cardiomyopathy, cardiac arrest, pseudoaldosteronism, myopathy, pulmonary and generalized edema. (AEHD3, 73; BSH, 58; BHC, 146; AEHD3, 72; CGBLH, 313) Should not be taken concurrently with corticosteroid treatment. (WHO1, 190; AEHD3, 77) May decrease plasma clearance and increase the AUC of prednisolone. Licorice may potentiate the activity of prednisolone and other corticosteroid drugs. (ESCOPM, 298; CGBLH, 313) Concurrent use of furosemide may potentiate development of acute renal failure. (AEHD3, 77) Potassium loss due to other drugs, e.g. thiazide diuretics, can be increased. With potassium loss, sensitivity to digitalis glycosides increases. (HM, 237; TGHM, 161; WHO1, 190) Excessive use of licorice may interact with antiarrhythmic drugs or with drugs which induce reversion to sinus rhythm (e.g. quinidine). (ESCOPM, 298) Should not be administered in conjunction with spironolactone or amiloride. (WHO1, 190) Insulin may be synergistic with glycyrrhizin in causing electrolyte disturbances and suppression of renin and aldosterone. (AEHD3, 77) There is a slight chance that licorice may counteract the contraceptive pill, on the basis of the constituent glycyrrhizin. (CGBLH, 312) Refer to the MediHerb Herb-Drug Interactions chart. Elecampane Inula helenium root 2b, 2c Occasional allergic reactions may occur. (BHC, 87) Large None known. (CGBLH, 193) doses causes vomiting, diarrhea, cramps, spasms, and symptoms of paralysis. (BSH, 64; TGHM, 329) Regulated in the U.S. as an allowable flavoring agent in alcoholic beverages only. (BSH, 64) Caution is advised in known sensitivity to elecampane or to other members of the Compositae family. (CGBLH, 193) Continues on next page Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 42 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Product and Ingredient Name Class Euphorbia Euphorbia hirta herb 2d Grindelia Grindelia camporum herb No information. High doses can produce kidney and stomach irritation. (BSH, 59) None known. (CGBLH, 224) Ginger Zingiber officinale rhizome 2b, 2d Contraindicated with gallstones; consult a physician first. (HM, 156; BSH, 125; TGHM, 136) May increase the chance of bleeding. (PPP, 401) A daily dose of 2 g of dried ginger should not be exceeded in pregnancy. Use with caution in cases of peptic ulceration, gastroesophageal reflux, or other gastric diseases. At doses approaching or greater than the maximum recommended dose, an increase in gastric secretory activity leading to heartburn is possible. (CGBLH, 227) Overdose may lead to a blood-thinning effect and an increase in gastric secretory activity leading to heartburn. (PPP, 401; ESCOPM, 548) Topical application may cause contact dermatitis in sensitive patients. (PPP, 401) None known. (HM, 156; TGHM, 136) May increase the absorption of pharmaceutical drugs. (PPP, 401) Caution indicated for daily doses of (dried) ginger in excess of 4 g with patients taking blood-thinning drugs such as warfarin, or aspirin or who have increased risk of hemorrhage. (PPP, 401; TCPHP, 129; CAACH, 106; CGBLH, 227) May enhance absorption of sulphaguanidine. (ESCOPM, 548) No information. In rare cases, allergic reactions affecting skin and respiratory system. (HM, 126; TGHM, 128) Avoid in those with sensitivity to anethole. Preparations containing the essential oil should not be used during pregnancy and lactation. (ESCOPM, 163) High doses (greater than 0.1–0.6 mL/day) are contraindicated in pregnancy, infants and toddlers. (TGHM, 128) Very high doses should be avoided in hepatic disorders. (Normal recommended daily dosage: 5–20 drops.) (PPP, 382) Should not be taken at an oral daily dose of 0.5 mL or above. (EOS, 113-114, 136) Interaction between fennel oil and drugs in humans is not known. (TGHM, 128; HM, 126; PPP, 382; AEDH1,138) Fennel Foeniculum vulgare fruit essential oil Large doses may cause nausea and vomiting, and it may occasionally cause epigastric distress with nausea. (CGBLH, 199) None known. (CGBLH, 199) Refer to the MediHerb Herb-Drug Interactions chart. Rhodiola & Ginseng Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Discontinue during an acute infection or fever. Rhodiola Rhodiola rosea root No information. No information. No information. Korean Ginseng Panax ginseng root 2d May interact with monoamine oxidase inhibitor phenelzine and also with warfarin, (PPP, 429; WHO1, 176) although studies are needed to verify the potential interaction with warfarin and the underlying mechanism. (ESCOPM, 212) Do not use with stimulants, including excessive use of caffeine. (HM, 174; PPP, 429) Note: Contraindicated for hypertension. (BSH, 81; HM, 174; CGBLH, 297) Contraindicated with signs of heat, acute infections, acute asthma, hypertension, excessive menstruation or nose bleeds. (PPP, 429; CAACH, 41) Consuming caffeine with ginseng increases the risk of overstimulation and gastrointestinal upset. (BSH, 81; BHC, 116) Concurrent use with amphetamines should be avoided. (CGBLH, 297) Higher doses can overstimulate and aggravate insomnia, irritability, depression, headache, palpitation, hypertension, and can cause tremor, euphoria, skin eruptions, menstrual abnormalities, diminished sexual function and weight loss. (BSH, 81; CAACH, 40) The use of ginseng is not associated with serious adverse effects if taken at the recommended dose level. (ESCOPM, 212) May cause side effects related to an estrogen-like activity in women. (CGBLH, 298) May reduce blood glucose levels, diabetic patients should consult with physician. (WHO1, 176; ESCOPM, 212) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 Refer to the MediHerb Herb-Drug Interactions chart. The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 43 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Saligesic Contraindicated in known allergy or sensitivity to salicylates. Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Willow Bark Salix purpurea stem bark 1 No relevant information found in reference texts. [Editor's note: However, use with caution during lactation as salicylates excreted in breast milk may cause rashes in babies. (Health care professionals should be aware of the possibility of Reye's syndrome, an acute sepsis-like illness encountered exclusively in children below 15 years of age. The cause is unknown, although viral agents and drugs, especially salicylates, have been implicated.)] None known. (ESCOPM, 446) Interactions like those encountered with salicylates may arise, however, there is no definite evidence for this to date. (HM, 410; TGHM, 230) Refer to the MediHerb Herb-Drug Interactions chart (under Willow Bark and Tannin- or OPC-containing herbs). Silymarin Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. In anemia and cases where iron supplementation is required, do not take simultaneously with meals or iron supplements. Milk Thistle Silybum marianum fruit Note: 1 Contraindicated in cases of known allergy to plants of the Asteraceae (Compositae) family. (WHO2, 310) Side effect: a mild laxative effect and mild gastrointestinal complaints have been observed in occasional instances from the standardized preparation. (HM, 260; TGHM, 170; WHO2, 310; CGBLH, 326) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 None known. (PPP, 560; HM, 261; TGHM, 170) Refer to the MediHerb Herb-Drug Interactions chart (under Milk Thistle and Polyphenolic- or Flavonoidcontaining herbs). The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 44 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs St John's Wort 1.8g Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Do not use this product while taking any prescription drug(s) without the advice of your prescribing physician. Avoid excessive exposure to UV irradiation (e.g. sunlight, tanning) when using this product. St John's Wort Hypericum perforatum herb flowering top Note: 2d Contraindicated in the treatment of serious depression with psychotic symptoms, suicidal risk or signs and symptoms that are so severe that they do not allow the patient’s family or work involvements to continue. (PPP, 549; ESCOPM, 259) Not to be taken after organ transplants. (ESCOPM, 258) Contraindicated in known photosensitivity and known allergy to plants of the Clusiaceae family. (WHO2, 163; CGBLH, 420) May cause mild stomach discomfort, skin rash, tiredness, fatigue, headache, sleep disturbances. Photosensitization is possible after exposure to sunlight and especially in fair skinned individuals. (BSH, 62; TGHM, 215; HM, 363; PPP, 548; ESCOPM, 259; WHO2, 163) Patients taking higher doses should avoid excessive exposure to sunlight and UV radiation. (CGBLH, 420) Caution advised in very severe debility, especially if associated with immune or digestive collapse, renal or hepatic failure, rampant cancer or strong regimes of chemotherapy. (PPP, 155) Dermatologic and neurologic concern based upon case reports. (TCPHP, 301) Side effects are rare and mild, and include minor gastrointestinal irritations, allergic reactions, tiredness and restlessness. (WHO2, 165) Mild, reversible elevations of serum liver enzymes noted in HIV-positive patients. Mania has been noted as a side effect but has not been conclusively linked to use of the herb. Avoid use of preparations made from herb harvested at the onset of full flowering, and avoid dispensing the sediment from liquid extracts – the resinous compounds contained therein may cause sensory nerve hypersensitivity. (CGBLH, 422) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 None known. (TGHM, 215; HM, 363) May potentiate pharmaceutical MAO-inhibitors. (BSH, 62, 173) Recommend physician consultation when taken with MAO inhibitors, SSRIs, and tricyclics (PPP, 549) Reduced blood levels have been reported with respect to cyclosporin, indinavir and potentially other antiretroviral protease and transcriptase inhibitors, the anticoagulants phenprocoumon and warfarin, theophylline and digoxin. It remains an open question whether St John’s wort preparations also interact with oral contraceptives, particularly low dose contraceptives (<50 mcg of estrogen). (ESCOPM, 259) Contraindicated in patients taking irinotecan. No clinical adverse effects have been reported for phenytoin or any other anticonvulsant drug. (CGBLH, 421) Refer to the MediHerb Herb-Drug Interactions chart (under St John’s Wort and Tannin- or OPC-containing herbs). The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 45 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Thyroid Complex Contraindicated in pregnancy and lactation. Contraindicated in hyperthyroidism and related cardiac problems. Bladderwrack Fucus vesiculosus whole plant 2b, 2c, 2d Contraindicated in hyperthyroidism, cardiac problems associated with hyperthyroidism, pregnancy and lactation. (BHC, 38; CGBLH, 103) Long-term therapeutic use is not recommended. (BSH, 54) Kelp (species undefined) has caused transient hyperthyroidism, raised levels of thyroid stimulating hormone, and in large doses (as a food – probably not bladderwrack) has caused subclinical hypothyroidism, Hashimoto's thyroiditis and rare extrathyroidal effects in susceptible individuals. (CGBLH, 103) In rare cases allergic reactions involving serious overall reactions may occur. (TGHM, 315) Marine organisms, including bladderwrack, naturally accumulate arsenic. However, this is mainly organically bound and rapidly excreted. For this reason the World Health Organization has established a tolerable weekly intake only for inorganic arsenic which is present in bladderwrack at considerably lower levels. (AEHD1, 42) However, isolated cases of adverse effects have been attributed to arsenic intake from various seaweeds. (AEHD1, 42) None known. (HM, 213) May interact with thyroid replacement therapies (thyroxine). (CGBLH, 103) Caution indicated if taking iodine-containing drugs. (AEHD3, 44) High dosages of alkaloids from Withania exhibit prolonged hypotensive, bradycardiac and respiratory stimulant actions, may also have depressant effect on higher cerebral centers; sedative effects have also been demonstrated. (CAACH, 138) None known. (PPP, 601; CGBLH, 73) May potentiate the effects of barbiturates. (BSH, 124) Withania (Ashwaganda) Withania somnifera root 2b, 2d Bacopa Bacopa monnieri herb No information. Containing saponins, this herb is a potential gastrointestinal irritant. (PPP, 46; CGBLH, 80) Refer to the MediHerb Herb-Drug Interactions chart. None known. (CAACH, 101-102; CGBLH, 80) Tribulus Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Tribulus Tribulus terrestris herb (aerial parts) Note: No information. Due to the presence of saponins, this herb may be a gastrointestinal irritant. (PPP, 46) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 This herb may increase FSH in women, which in turn increases levels of estrogen. (PPP, 46) The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 46 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs UriCo Phytosynergist® Contraindicated in known allergy to plants of the daisy family. Contraindicated in high blood pressure, edema (water retention), congestive heart failure, low blood potassium, pregnancy and lactation. Not to be taken long-term. Couch Grass Agropyron repens rhizome No information. Copious fluid intake and herbal treatment is inadvisable None known. (TGHM, 118; CGBLH, 161) if edema due to cardiac or renal insufficiency is present. (TGHM, 118) The use of this diuretic may be inappropriate and possibly even contraindicated in renal failure and diabetes. (PPP, 222) Echinacea Echinacea angustifolia root 1 Commission E cautioned that Echinacea pallida root and E. angustifolia herb and root should not be used in systemic diseases such as tuberculosis, leukosis, collagenosis, multiple sclerosis, AIDS, HIV infections, and other autoimmune diseases (based on theoretical considerations and not on any reports of adverse findings). Other authoritative sources do not support these restrictions. (HM, 94; TGHM, 121, 328; PPP, 359-360) Allergic reactions, mainly contact dermatitis, may occur rarely in susceptible patients from Echinacea aerial parts. The likelihood of Echinacea root preparations causing allergy is very low. (CGBLH, 185) None known. (HM, 95; PPP, 360) Caution is advised for transplant patients taking immunosuppressive drugs, short-term therapy only is suggested. (PPP, 360; CGBLH, 185) Should not be taken concurrently with corticosteroid treatment. (WHO1, 190; AEHD3, 77) May decrease plasma clearance and increase the AUC of prednisolone. Licorice may potentiate the activity of prednisolone and other corticosteroid drugs. (ESCOPM, 298; CGBLH, 313) Concurrent use of furosemide may potentiate development of acute renal failure. (AEHD3, 77) Potassium loss due to other drugs, e.g. thiazide diuretics, can be increased. With potassium loss, sensitivity to digitalis glycosides increases. (HM, 237; TGHM, 161; WHO1, 190) Excessive use of licorice may interact with antiarrhythmic drugs or with drugs which induce reversion to sinus rhythm (e.g. quinidine). (ESCOPM, 298) Should not be administered in conjunction with spironolactone or amiloride. (WHO1, 190) Insulin may be synergistic with glycyrrhizin in causing electrolyte disturbances and suppression of renin and aldosterone. (AEHD3, 77) There is a slight chance that licorice may counteract the contraceptive pill, on the basis of the constituent glycyrrhizin. (CGBLH, 312) Licorice Glycyrrhiza glabra root 2b, 2c, 2d It is recommended that patients with cardiovascular or renal disease use licorice only under care of health care professional. (TCPHP, 232; PPP, 474) Patients prone to potassium deficiency are also advised not to use licorice. (TCPHP, 232; TGHM, 161) Treatment not to exceed six weeks. (TCPHP, 232; BSH, 58; TGHM, 162) Contraindications: hypertension, cholestatic liver disorders, inflammatory liver disorders, liver cirrhosis, hypertonia, hypokalemia, severe obesity and severe kidney insufficiency (HM, 236; BSH, 58; BHC, 146; TGHM, 161; WHO1, 190; AEHD3, 72; ESCOPM, 298) pregnancy and lactation (ESCOPM, 298). In the case of pregnancy doses up to 3 g per day are likely to be safe. (PPP, 474) Also contraindicated if there is edema or congestive heart failure. (PPP, 474) Caution is advised with elderly patients. (CGBLH, 312) Ingestion of an excessive amount can lead to severe hypertension, cardiac arrhythmias, cardiomyopathy, cardiac arrest, pseudoaldosteronism, myopathy, pulmonary and generalized edema. (AEHD3, 73; BSH, 58; BHC, 146; AEHD3, 72; CGBLH, 313) Buchu Barosma betulina leaf 2b, 2d Occasional gastrointestinal intolerance and irritation on empty stomach. (PPP, 311; BHC, 44) Contraindicated in kidney inflammation. (BSH, 19) Refer to the MediHerb Herb-Drug Interactions chart. Refer to the MediHerb Herb-Drug Interactions chart. Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 None known. (PPP, 311; BSH, 19; TGHM, 317; CGBLH, 111) The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 47 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Valerian Complex Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Valerian Valeriana officinalis root & rhizome 1 Can aggravate a sensation of tiredness or drowsiness, particularly in higher doses. (PPP, 587; WHO1, 273) Overdose can result in blurred vision, erratic heart beat, headache, nausea, restlessness, visual illusions, even spasmodic movements. (PPP, 588; BSH, 120) Very large doses may cause bradycardia and arrhythmias, and decrease intestinal motility. (WHO1, 274) Canada allows products containing valerian for use as sleeping aids and sedatives. (TCPHP, 64) Hepatic and neurologic concern based upon case reports, although in the case of alleged hepatotoxicity coingestants were involved. (TCPHP, 301) None known. (TGHM, 226; ESCOPM, 540; HM, 397) May increase the effects of CNS depressants or alcohol when taken together, (PPP, 587; AEHD3, 172; WHO1, 273) although human studies indicate that this is unlikely for alcohol. (CGBLH, 447) The herb may be expected to have at least an additive effect with barbiturates, alcohol, benzodiazepines, and other CNS depressants. (TCPHP, 64) Refer to the MediHerb Herb-Drug Interactions chart. Passion Flower Passiflora incarnata herb 1 Hypersensitivity is possible in very rare cases. May cause drowsiness. One case of nausea, bradycardia and ventricular arrhythmia has been reported. (ESCOPM, 4) Herbal sedatives such as passion flower are also contraindicated in patients with depression and insomnia marked by increasing restlessness during the early hours of the morning. (PPP, 233) None known. (HM, 295; TGHM, 180; CGBLH, 362) Spiny Jujube Zizyphus spinosa seed 2b Based on animal experiments, the herb has anticonvulsant and hypotensive properties; sedative effects have been observed. (CAACH, 88) Noted as uterine stimulant. (BSH, 125) Zizyphus has synergistic effects with many sedatives and hypnotics. (CAACH, 88) Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 48 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Vitanox® Contraindicated in pregnancy. Contraindicated during lactation unless otherwise directed by a qualified health care professional. Contraindicated in closure of the gallbladder. Use only with professional supervision in gallstones. In anemia and cases where iron supplementation, do not take simultaneously with meals or iron supplements. Rosemary Rosmarinus officinalis leaf 2b Contraindications: pregnancy (PPP, 100) and hypersensitivity to rosemary leaf and rosemary preparations, especially those containing carnosol. (ESCOPM, 430) Caution may be warranted in women wishing to conceive. (CGBLH, 389) None known. (HM, 327; TGHM, 197; ESCOPM, 430) Avoid concomitant administration of rosemary during iron intake. In anemia and cases for which iron supplementation is required, rosemary should not be taken simultaneously with meals or iron supplements. (CGBLH, 389) Refer to the MediHerb Herb-Drug Interactions chart (under Polyphenolic- or Flavonoid-containing herbs). Green Tea Camellia sinensis leaf Class not defined for green tea. Use cautiously in patients with highly inflamed, ulcerated or damaged gastrointestinal tissue. (PPP, 37) Tannin-containing herbs may reduce the absorption of pharmacological substances e.g. metal ions (iron supplements) and thiamine. Avoid concurrent consumption. (PPP, 37, 103) Refer to the MediHerb Herb-Drug Interactions chart (under Polyphenolic- or Flavonoid-containing herbs and Tannin- or OPC-containing herbs). Turmeric Curcuma longa rhizome Grape Seed Vitis vinifera seed 2b, 2d Contraindicated in obstruction of bile passages; in case of gallstones, use only after consulting with a physician. (TGHM, 222; HM, 382; WHO1, 121; PPP, 578; ESCOPM, 107) The herb should not be administered to patients who suffer from stomach ulcers or hyperacidity. (BSH, 39; HM, 382) Occasional cases of allergic dermatitis reported. (WHO1, 121; PPP, 578) Care should be exercised with women wishing to conceive and patients complaining of hair loss. (CGBLH, 436) Patients applying topical doses should be cautioned against excessive exposure to sunlight. (PPP, 578) No information. No information. None known. (HM, 382; TGHM, 222; ESCOPM, 108) High doses (>15 g/day) should not be given to patients taking antiplatelet or anticoagulant drugs. (PPP, 578; CGBLH, 436) Refer to the MediHerb Herb-Drug Interactions chart. No information. Refer to the MediHerb Herb-Drug Interactions chart (under Tannin- or OPC-containing herbs). Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 49 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Wild Yam Complex Contraindicated in pregnancy. Contraindicated during lactation unless otherwise directed by a qualified health care professional. Discontinue during an acute infection or fever. Do not use this product while taking any prescription drug(s) without the advice of your prescribing physician. Avoid excessive exposure to UV irradiation (e.g. sunlight, tanning) when using this product. Wild Yam Dioscorea villosa root & rhizome 1 Shatavari Asparagus racemosus root No information. None known. (CGBLH, 409) None known. (CGBLH, 409) St John's Wort Hypericum perforatum herb flowering top 2d None known. (TGHM, 215; HM, 363) May potentiate pharmaceutical MAO-inhibitors. (BSH, 62, 173) Recommend physician consultation when taken with MAO inhibitors, SSRIs, and tricyclics (PPP, 549) Reduced blood levels have been reported with respect to cyclosporin, indinavir and potentially other antiretroviral protease and transcriptase inhibitors, the anticoagulants phenprocoumon and warfarin, theophylline and digoxin. It remains an open question whether St John’s wort preparations also interact with oral contraceptives, particularly low dose contraceptives (<50 mcg of estrogen). (ESCOPM, 259) Contraindicated in patients taking irinotecan. No clinical adverse effects have been reported for phenytoin or any other anticonvulsant drug. (CGBLH, 421) Large doses produce emesis. (BSH, 42) Oral use may cause irritation of the gastric mucous membranes and reflux. (CGBLH, 464) Also classified as choleretic and cholagogue, the herb is either contraindicated or at least inappropriate in the following: (1) obstructed bile ducts, (2) unconjugated hyperbilirubinemia, (3) acute or severe hepatocellular disease, (4) septic cholecystitis (where there is risk of peritonitis), (5) intestinal spasm or ileus, and (6) liver cancer. (PPP, 187) Contraindicated in the treatment of serious depression with psychotic symptoms, suicidal risk or signs and symptoms that are so severe that they do not allow the patient’s family or work involvements to continue. (PPP, 549; ESCOPM, 259) Not to be taken after organ transplants. (ESCOPM, 258) Contraindicated in known photosensitivity and known allergy to plants of the Clusiaceae family. (WHO2, 163; CGBLH, 420) May cause mild stomach discomfort, skin rash, tiredness, fatigue, headache, sleep disturbances. Photosensitization is possible after exposure to sunlight and especially in fair skinned individuals. (BSH, 62; TGHM, 215; HM, 363; PPP, 548; ESCOPM, 259; WHO2, 163) Patients taking higher doses should avoid excessive exposure to sunlight and UV radiation. (CGBLH, 420) Caution advised in very severe debility, especially if associated with immune or digestive collapse, renal or hepatic failure, rampant cancer or strong regimes of chemotherapy. (PPP, 155) Dermatologic and neurologic concern based upon case reports. (TCPHP, 301) Side effects are rare and mild, and include minor gastrointestinal irritations, allergic reactions, tiredness and restlessness. (WHO2, 165) Mild, reversible elevations of serum liver enzymes noted in HIV-positive patients. Mania has been noted as a side effect but has not been conclusively linked to use of the herb. Avoid use of preparations made from herb harvested at the onset of full flowering, and avoid dispensing the sediment from liquid extracts – the resinous compounds contained therein may cause sensory nerve hypersensitivity.(CGBLH, 422) None known. (CGBLH, 464) Consult physician when patient is being treated with estrogen-promoting drugs. (PPP, 46, 245) The herb is contraindicated or at least inappropriate when there is already prescription of strong anti-inflammatory medication. (PPP, 149) Refer to the MediHerb Herb-Drug Interactions chart (under St John’s Wort and Tannin- or OPC-containing herbs). Continues on next page Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 50 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Sage Salvia officinalis herb 2b, 2d Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Leaf and essential oil are contraindicated in pregnancy and lactation. (CGBLH, 394; TGHM, 198) After prolonged ingestion of alcohol extracts or of the pure essential oil, epileptiform convulsions can occur. (HM, 332; TGHM, 198) Caution is advised with the use of alcoholic preparations and the pure essential oil because of the presence of thujone. (ESCOPM, 453; HM, 332; TGHM, 198) Do not exceed the recommended dose, take with caution if using long term. (CGBLH, 394) None known. (HM, 332; ESCOPM, 453; TGHM, 198; BSH, 102; CGBLH, 394) Refer to the MediHerb Herb-Drug Interactions chart (under Tannin- or OPC-containing herbs). Black Cohosh Cimicifuga racemosa root 2b, 2c Contraindicated in pregnancy (except during the last month to assist with birth), lactation and in women with estrogen-dependent tumors such as breast cancer. (PPP, 307; CGBLH, 96) Occasional gastrointestinal discomfort may occur and large doses may cause vertigo, headache, nausea, impaired vision, vomiting, and impaired circulation. An estrogenic effect and lowering of blood pressure have been recorded. (BSH, 29-30; BHC, 35; HM, 25; PPP, 307-308; ESCOPM, 80; CGBLH, 96) Canadian regulations do not allow the herb as a non-medicinal ingredient for oral use products. (BSH, 30) None known. (TGHM, 90; HM, 25; PPP, 307; ESCOPM, 80) Black cohosh demonstrated an antiproliferative effect in vitro when combined with tamoxifen. Whether this favorable interaction also applies in vivo has not been established. (CGBLH, 96) Korean Ginseng Panax ginseng root 2d Contraindicated for hypertension. (BSH, 81; HM, 174; CGBLH, 297) Contraindicated with signs of heat, acute infections, acute asthma, hypertension, excessive menstruation or nose bleeds. (PPP, 429; CAACH, 41) Consuming caffeine with ginseng increases the risk of overstimulation and gastrointestinal upset. (BSH, 81; BHC, 116) Concurrent use with amphetamines should be avoided. (CGBLH, 297) Higher doses can overstimulate and aggravate insomnia, irritability, depression, headache, palpitation, hypertension, and can cause tremor, euphoria, skin eruptions, menstrual abnormalities, diminished sexual function and weight loss. (BSH, 81; CAACH, 40) The use of ginseng is not associated with serious adverse effects if taken at the recommended dose level. (ESCOPM, 212) May cause side effects related to an estrogen-like activity in women. (CGBLH, 298) May reduce blood glucose levels, diabetic patients should consult with physician. (WHO1, 176; ESCOPM, 212) May interact with monoamine oxidase inhibitor phenelzine and also with warfarin, (PPP, 429; WHO1, 176) although studies are needed to verify the potential interaction with warfarin and the underlying mechanism. (ESCOPM, 212) Do not use with stimulants, including excessive use of caffeine. (HM, 174; PPP, 429) Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 Refer to the MediHerb Herb-Drug Interactions chart. The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 51 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Withania Complex Contraindicated in high blood pressure, edema (water retention), congestive heart failure, low blood potassium, pregnancy and lactation. Discontinue during an acute infection or fever. Skullcap Scutellaria lateriflora herb 1 None known. (CGBLH, 415) May be contraindicated in depression and insomnia marked by increasing restlessness during the early hours of the morning. (PPP, 233) High doses may cause giddiness, stupor, confusion, twitching, arrhythmias, and epilepsy. (TCPHP, 218) Reports of toxicity are likely due to adulteration with germander. (BSH, 105) Licorice Glycyrrhiza glabra root 2b, 2c, 2d It is recommended that patients with cardiovascular or renal disease use licorice only under care of health care professional. (TCPHP, 232; PPP, 474) Patients prone to potassium deficiency are also advised not to use licorice. (TCPHP, 232; TGHM, 161) Treatment not to exceed six weeks. (TCPHP, 232; BSH, 58; TGHM, 162) Contraindications: hypertension, cholestatic liver disorders, inflammatory liver disorders, liver cirrhosis, hypertonia, hypokalemia, severe obesity and severe kidney insufficiency (HM, 236; BSH, 58; BHC, 146; TGHM, 161; WHO1, 190; AEHD3, 72; ESCOPM, 298) pregnancy and lactation (ESCOPM, 298). In the case of pregnancy doses up to 3 g per day are likely to be safe. (PPP, 474) Also contraindicated if there is edema or congestive heart failure. (PPP, 474) Caution is advised with elderly patients. (CGBLH, 312) Ingestion of an excessive amount can lead to severe hypertension, cardiac arrhythmias, cardiomyopathy, cardiac arrest, pseudoaldosteronism, myopathy, pulmonary and generalized edema. (AEHD3, 73; BSH, 58; BHC, 146; AEHD3, 72; CGBLH, 313) Should not be taken concurrently with corticosteroid treatment. (WHO1, 190; AEHD3, 77) May decrease plasma clearance and increase the AUC of prednisolone. Licorice may potentiate the activity of prednisolone and other corticosteroid drugs. (ESCOPM, 298; CGBLH, 313) Concurrent use of furosemide may potentiate development of acute renal failure. (AEHD3, 77) Potassium loss due to other drugs, e.g. thiazide diuretics, can be increased. With potassium loss, sensitivity to digitalis glycosides increases. (HM, 237; TGHM, 161; WHO1, 190) Excessive use of licorice may interact with antiarrhythmic drugs or with drugs which induce reversion to sinus rhythm (e.g. quinidine). (ESCOPM, 298) Should not be administered in conjunction with spironolactone or amiloride. (WHO1, 190) Insulin may be synergistic with glycyrrhizin in causing electrolyte disturbances and suppression of renin and aldosterone. (AEHD3, 77) There is a slight chance that licorice may counteract the contraceptive pill, on the basis of the constituent glycyrrhizin. (CGBLH, 312) Refer to the MediHerb Herb-Drug Interactions chart. Withania (Ashwaganda) Withania somnifera root 2b, 2d High dosages of alkaloids from Withania exhibit prolonged hypotensive, bradycardiac and respiratory stimulant actions, may also have depressant effect on higher cerebral centers; sedative effects have also been demonstrated. (CAACH, 138) None known. (PPP, 601; CGBLH, 73) May potentiate the effects of barbiturates. (BSH, 124) Continues on next page Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 52 Contraindications and Cautions Tablets, Capsules & Phytosynergist® Liquid Complexes Product and Ingredient Name Class Korean Ginseng Panax ginseng root 2d Contraindications, Cautions and Potential Adverse Reactions Contraindicated for hypertension. (BSH, 81; HM, 174; CGBLH, 297) Contraindicated with signs of heat, acute infections, acute asthma, hypertension, excessive menstruation or nose bleeds. (PPP, 429; CAACH, 41) Consuming caffeine with ginseng increases the risk of overstimulation and gastrointestinal upset. (BSH, 81; BHC, 116) Concurrent use with amphetamines should be avoided. (CGBLH, 297) Higher doses can overstimulate and aggravate insomnia, irritability, depression, headache, palpitation, hypertension, and can cause tremor, euphoria, skin eruptions, menstrual abnormalities, diminished sexual function and weight loss. (BSH, 81; CAACH, 40) The use of ginseng is not associated with serious adverse effects if taken at the recommended dose level. (ESCOPM, 212) May cause side effects related to an estrogen-like activity in women. (CGBLH, 298) May reduce blood glucose levels, diabetic patients should consult with physician. (WHO1, 176; ESCOPM, 212) Interactions with Drugs May interact with monoamine oxidase inhibitor phenelzine and also with warfarin, (PPP, 429; WHO1, 176) although studies are needed to verify the potential interaction with warfarin and the underlying mechanism. (ESCOPM, 212) Do not use with stimulants, including excessive use of caffeine. (HM, 174; PPP, 429) Refer to the MediHerb Herb-Drug Interactions chart. Wormwood Complex Contraindicated in pregnancy and lactation. Stemona Stemona sessilifolia root No information. No information. No information. Black Walnut Juglans nigra green hulls 2d Prolonged use is not advised due to the presence of significant quantities of juglone, a known mutagen in animals. Carcinogenic effects associated with the chronic external use of Juglans regia have been observed, but are inconclusive in regard to Juglans nigra. (BSH, 65; TGHM, 381) None known. (TGHM, 227; HM, 402) Wormwood Artemisia absinthium herb 2b, 2c, 2d None known. (BSH, 15; TGHM, 233; ESCOPM, 4; Contraindications: gastric and duodenal ulcers, pregnancy, lactation, hyperacidity, known sensitivity to CGBLH, 469) wormwood or other members of the Compositae family. (ESCOPM, 4; CGBLH, 469) The toxicological risk from use of conventional wormwood preparations is considered to be very low. (ESCOPM, 4) The recommended dosage range must not be exceeded. (CGBLH, 469) As a bitter, this herb is contraindicated or at least inappropriate in duodenal ulceration and conditions involving dry cough and some kidney diseases. (PPP, 173) Wormwood contains approximately 1.5–1.7% essential oil which contains a neurotoxin called thujone. In toxic doses, thujone acts as a convulsant poison. Therefore, the pure essential oil must not be used. (TGHM, 233; BSH, 158) Regulatory restrictions require finished food products to be thujone-free in the U.S. and other countries. (BSH, 15) Toxicological concern not indicated, except in long term use. (BSH, 15) Clove Syzygium aromaticum bud essential oil No information. Oil of clove may be irritating to mucosal tissues. (TGHM, At an oral daily dose of 0.5 mL or above: use with caution in those taking anticoagulants or 112) acetominophen. (EOS, 113-114, 131) At an oral daily dose of 0.5 mL or above: use with caution in alcoholism, hemophilia, kidney disease, liver disease, prostate cancer, systemic lupus erythematosus. (EOS, 113-114, 131) Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 53 Contraindications and Cautions Liquid Extracts Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Albizia 1:2 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Albizia Albizia lebbek bark No information. None known. (CAACH, 94) Since the herb contains saponins, it may be a gastrointestinal irritant. It may also be contraindicated or at least inappropriate in topical application to open wounds, patients with celiac disease, and some upper digestive irritations. (PPP, 46, 170) None known. (CAACH, 95; CGBLH, 59) Ashwaganda 1:1 Standardized Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Ashwaganda Withania somnifera root 2b, 2d High dosages of alkaloids from Withania exhibit prolonged hypotensive, bradycardiac and respiratory stimulant actions, may also have depressant effect on higher cerebral centers; sedative effects have also been demonstrated. (CAACH, 138) None known. (PPP, 601; CGBLH, 73) May potentiate the effects of barbiturates. (BSH, 124) Astragalus 1:2 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Discontinue during an acute infection or fever. Astragalus Astragalus membranaceus root 1 Contraindications: not advisable in acute infections. (PPP, None known. (PPP, 277; WHO1, 56; BSH, 17; CGBLH, 277; CAACH, 19; CGBLH, 77) 77) Bacopa 1:2 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Bacopa Bacopa monnieri herb No information. Containing saponins, this herb is a potential gastrointestinal irritant. (PPP, 46; CGBLH, 80) None known. (CAACH, 101-102; CGBLH, 80) Bilberry 1:1 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Bilberry Vaccinium myrtillus fruit 1 Very high doses should be used cautiously in patients with hemorrhagic disorders and in those taking warfarin or antiplatelet drugs. (PPP, 301) Mild side effects affecting the gastrointestinal, cutaneous and nervous systems observed in a small percentage of patients. (CGBLH, 93) None known. (HM, 18; TGHM, 88; ESCOPM, 346) Possible interaction with warfarin and antiplatelet drugs in very high doses. (PPP, 301) Refer to the MediHerb Herb-Drug Interactions chart. Black Cohosh 1:2 Quantified Activity Contraindicated in pregnancy, lactation, and in women with estrogen-dependent tumors such as breast cancer. Caution in patients with liver problems, who frequently use alcohol or take any medications. Black Cohosh Cimicifuga racemosa root Note: 2b, 2c Contraindicated in pregnancy (except during the last month to assist with birth), lactation and in women with estrogen-dependent tumors such as breast cancer. (PPP, 307; CGBLH, 96) Occasional gastrointestinal discomfort may occur and large doses may cause vertigo, headache, nausea, impaired vision, vomiting, and impaired circulation. An estrogenic effect and lowering of blood pressure have been recorded. (BSH, 29-30; BHC, 35; HM, 25; PPP, 307-308; ESCOPM, 80; CGBLH, 96) Canadian regulations do not allow the herb as a non-medicinal ingredient for oral use products. (BSH, 30) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 None known. (TGHM, 90; HM, 25; PPP, 307; ESCOPM, 80) Black cohosh demonstrated an antiproliferative effect in vitro when combined with tamoxifen. Whether this favorable interaction also applies in vivo has not been established. (CGBLH, 96) The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 54 Contraindications and Cautions Liquid Extracts Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Black Walnut Hulls 1:10 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Black Walnut Juglans nigra hulls 2d Prolonged use is not advised due to the presence of significant quantities of juglone, a known mutagen in animals. Carcinogenic effects associated with the chronic external use of Juglans regia have been observed, but are inconclusive in regard to Juglans nigra. (BSH, 65; TGHM, 381) None known. (TGHM, 227; HM, 402) Bladderwrack 1:1 Contraindicated in pregnancy and lactation. Contraindicated in hyperthyroidism and cardiac problems. Bladderwrack Fucus vesiculosus herb 2b, 2c, 2d Contraindicated in hyperthyroidism, cardiac problems associated with hyperthyroidism, pregnancy and lactation. (BHC, 38; CGBLH, 103) Long-term therapeutic use is not recommended. (BSH, 54) Kelp (species undefined) has caused transient hyperthyroidism, raised levels of thyroid stimulating hormone, and in large doses (as a food – probably not bladderwrack) has caused subclinical hypothyroidism, Hashimoto’s thyroiditis and rare extrathyroidal effects in susceptible individuals. (CGBLH, 103) In rare cases allergic reactions involving serious overall reactions may occur. (TGHM, 315) Marine organisms, including bladderwrack, naturally accumulate arsenic. However, this is mainly organically bound and rapidly excreted. For this reason the World Health Organization has established a tolerable weekly intake only for inorganic arsenic which is present in bladderwrack at considerably lower levels. (AEHD1, 42) However, isolated cases of adverse effects have been attributed to arsenic intake from various seaweeds. (AEHD1, 42) None known. (HM, 213) May interact with thyroid replacement therapies (thyroxine). (CGBLH, 103) Caution indicated if taking iodine-containing drugs. (AEHD3, 44) Refer to the MediHerb Herb-Drug Interactions chart. Bugleweed 1:2 Contraindicated in pregnancy and lactation. Contraindicated in hypothyroidism and enlargement of the thyroid without functional disorder. Bugleweed Lycopus spp. herb 2b, 2c, 2d Contraindicated in thyroid hypofunction, enlargement of the thyroid without functional disorders, (TGHM, 99; BSH, 72) pregnancy and lactation. (AEHD2, 248; CGBLH, 113) Adverse reactions occurring occasionally include undesired thyroidal effects (including enlarged thyroid) and headache. (AEHD2, 248) None known. (TGHM, 99) Do not take with thyroid medications. (BSH, 72; TGHM, 99) Administration of the herb interferes with diagnostic procedures using radioactive isotopes. (TGHM, 99; AEHD2, 248; CGBLH, 113) Refer to the MediHerb Herb-Drug Interactions chart. Bupleurum 1:2 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Bupleurum Bupleurum falcatum root Note: 1 Contraindicated in deficient yin cough, or liver fire ascending to the head, such as some cases of headache and hypertension. (CGBLH, 116) Bupleurum has a slight sedative effect in some patients and may also increase bowel movements and flatulence (wind). (CAACH, 23; WHO1, 73, 74; PPP, 317) May cause nausea and reflux in sensitive patients. (PPP, 317) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 The use of alcohol, sedatives and other central nervous system depressants, in conjunction with this herb, may cause synergistic sedative effects. (WHO1, 73) The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 55 Contraindications and Cautions Liquid Extracts Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Burdock 1:2 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Burdock Arctium lappa root 1 None known. (BHC, 46; TGHM, 318) None known. (CGBLH, 118) Calendula 1:2 Contraindicated in known allergy to plants of the daisy family. Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Calendula Calendula officinalis flower No information. Inappropriate when there is already prescription of strong anti-inflammatory medication, (PPP, 148) and for those with known sensitivity to members of the Compositae family. (ESCOPM, 59; WHO2, 41; CGBLH, 120) Weak skin sensitization and a case of anaphylactic shock has been reported from topical use (a gargle). (CGBLH, 120) None known. (HM, 45; ESCOPM, 59; TGHM, 100, 319; CGBLH, 120) Californian Poppy 1:2 Contraindicated in pregnancy and lactation. Californian Poppy Eschscholtzia californica herb 2b, 2d This herb should be restricted in its application to experienced and well-trained practitioners. (PPP, 232) There is a theoretically increased risk of neurotoxicity and other adverse effects (although no known incidence). (PPP, 233) The following cases should be approached with caution: (1) concurrent prescription of powerful analgesics, (2) pain in children, (3) neurological disease, (4) depression and psychosis, (5) liver and kidney disease, and (6) history of allergic or anaphylactic reactions. (PPP, 232) None known. (CGBLH, 124) May potentiate pharmaceutical MAO-inhibitors. (BSH, 49) Cat’s Claw 1:2 Quantified Activity Contraindicated in pregnancy and lactation. Cat’s Claw Uncaria tomentosa inner bark 4 None known. (CGBLH, 131) Contraindicated in patients undergoing skin grafts and organ transplants; hemophiliacs prescribed fresh blood plasma; simultaneous administration of certain vaccines, hormone therapies, thymus extracts, and insulin and children under three years of age. (BSH, 119) Use with caution in pregnancy and lactation. Diarrhea and indigestion have been reported in several patients. (CGBLH, 131) Celery Seed 1:2 Quantified Activity Contraindicated in kidney disorders. Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Celery Seed Apium graveolens fruit Note: 2b, 2d None known. (CGBLH, 134) Apium graveolens can cause rare allergic reactions, even ending in anaphylactic shock (‘celery-carrotmugwort’ allergic reaction). (TGHM, 320; BHC, 57) Refer to the MediHerb Herb-Drug Interactions chart. Can contain phototoxic furanocoumarins. (TGHM, 320) The BHC recommends that celery is contraindicated in kidney disorders and pregnancy, (BHC, 57) although no evidence has been found for the contraindication in pregnancy. (CGBLH, 134) As a diuretic, inappropriate and possibly contraindicated in renal failure and diabetes. (PPP, 222; BSH, 11) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 56 Contraindications and Cautions Liquid Extracts Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Chamomile High Grade 1:2 Quantified Activity Contraindicated in known allergy to plants of the daisy family. Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Chamomile Matricaria recutita flower 1 Contraindicated in known allergy to chamomile or other members of the Compositae family. (CGBLH, 137) May cause rare contact allergy. (BHC, 155) Allergic concern based upon case reports. (TCPHP, 301) Highly concentrated hot tea is noted as emetic. (BSH, 74) German Standard License requires the following label: “The infusion should not be used near the eyes.” (BSH, 74) The pollen contained in these infusions appears to be responsible for the allergic reaction. (CGBLH, 138) None known. (TGHM, 107; HM, 60; BHC, 155) Avoid concomitant administration of chamomile during iron intake. In anemia and cases for which iron supplementation is required, chamomile should not be taken simultaneously with meals or iron supplements. (CGBLH, 137-138) Refer to the MediHerb Herb-Drug Interactions chart (under Polyphenolic- or Flavonoid-containing herbs). Chaste Tree 1:2 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Chaste Tree Vitex agnus-castus fruit 2b, 2d Contraindicated in conjunction with progesterone drugs, the contraceptive pill, or HRT. (PPP, 332; BSH, 123; ESCOPM, 9) The herb may aggravate pure spasmodic dysmenorrhea not associated with PMS. (PPP, 332) Rare occurrences of itching, urticaria and headache have been reported. (PPP, 333; BSH, 123; HM, 63; TGHM, 108; ESCOPM, 9; CGBLH, 142) Should be used cautiously during pregnancy and only in the early stages for treating insufficient corpus luteal function. (CGBLH, 142) May interact antagonistically with dopamine receptor antagonists, progesterone drugs, contraceptive pill or HRT. (PPP, 332; HM, 63; TGHM, 108; CGBLH, 142) Chinese Skullcap 1:2 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Chinese Skullcap Scutellaria baicalensis root 1 Traditionally contraindicated in cold conditions. (CGBLH, 83) Gastric discomfort occurs rarely. (AEHD2, 291) None known. (CGBLH, 83) Cinnamon Quills 1:2 Contraindicated in pregnancy and lactation. Contraindicated in known allergy to cinnamon and Peruvian balsam. Cinnamon Cinnamomum cassia stem bark 2b, 2d As an aromatic, the herb may be contraindicated or inappropriate in gastroesophageal reflux. (PPP, 171, 211) Allergic reactions of the skin and mucosa have been reported. (WHO1, 102; HM, 66; TGHM, 110; BSH, 31) The herb is contraindicated in pregnancy, cases of stomach or duodenal ulcers, and in patients with an allergy to cinnamon, cinnamon bark oil, cinnamaldehyde or Peruvian balsam. (WHO1, 101; HM, 66; TGHM, 110; ESCOPM, 93) Cinnamon does not present any special risk in pregnancy, but prolonged use of the essential oil should be restricted during pregnancy. (AEHD1, 111) None known. (HM, 66; TGHM, 110; ESCOPM, 93; CGBLH, 149) Cleavers 1:2 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Cleavers Galium aparine herb Note: 1 This herb may be provocative to skin disease, and care needs to be taken to reduce the prospects for major exacerbations. (PPP, 254) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 None known. (BHC, 61; CGBLH, 152) The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 57 Contraindications and Cautions Liquid Extracts Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Coleus 1:1 Quantified Activity Contraindicated in hypotension. Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Coleus Coleus forskohlii root No information. Contraindicated in hypotension. (CAACH, 106) Use cautiously in peptic ulcer. (CGBLH, 156) Forskolin has the ability to potentiate many drugs. Use cautiously in patients taking prescribed medication, especially hypotensive and antiplatelet drugs. (CAACH, 106; CGBLH, 156) Refer to the MediHerb Herb-Drug Interactions chart. Corn Silk 1:1 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Corn Silk Zea mays styles & stigma 1 May be inappropriate and possibly even contraindicated None known. (CGBLH, 160) with renal failure and diabetes. (PPP, 222) Regulated in the U.S. as an allowable ingredient in certain listed foods. (BSH, 125) Cramp Bark 1:2 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Cramp Bark Viburnum opulus bark No information. Nausea and vomiting may occur with large doses. None known. (CGBLH, 164) (CGBLH, 100) Canadian regulations do not allow cramp bark as a non-medicinal ingredient for oral use products. (BSH, 122) Damiana 1:2 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Damiana Turnera diffusa leaf 1 Possible contraindication in patients with extremely debilitated constitutions. (PPP, 234) None known. (TGHM, 326; CGBLH, 171) Dandelion Leaves 1:1 Contraindicated in closure of the gallbladder. Use only with professional supervision in gallstones. Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Dandelion Taraxacum officinale leaf 2d None known. (TGHM, 119; HM, 80, 81; ESCOPM, Contraindicated with occlusion of the bile ducts, 500; CGBLH, 173) gallbladder empyema (including cholecystitis), and obstructive ileus. (ESCOPM, 499-500; BSH, 114; HM, 80; TGHM, 120; CGBLH, 173) Due to the bitter substances within this herb, it may also cause gastric hyperacidity and increased ulcer pain. (TGHM, 120; BSH, 114) Contact allergies caused by sesquiterpene lactones in the latex have been rarely observed. (HM, 80; TGHM, 119) Dandelion Root 1:2 Contraindicated in closure of the gallbladder. Use only with professional supervision in gallstones. Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Dandelion Taraxacum officinale root Note: None known. (TGHM, 119; HM, 80, 81; ESCOPM, No information. Contraindicated or at least inappropriate in the 503; CGBLH, 173) following: (1) obstructed bile ducts, (2) unconjugated hyperbilirubinemia, (3) acute or severe hepatocellular disease, (4) septic cholecystitis (where there is risk of peritonitis), (5) intestinal spasm or ileus, (6) liver cancer and (7) gall bladder empyema. (PPP, 187; BHC, 73, 76; ESCOPM, 503; BSH, 114) In case of gallstones, first consult a physician. (HM, 80, 81) May cause superacidic stomach problems. (BSH, 114) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 58 Contraindications and Cautions Liquid Extracts Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Dong Quai 1:2 Contraindicated in the first trimester of pregnancy, especially in higher doses. Do not use in severe menorrhagia. Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Dong Quai Angelica polymorpha (Angelica sinensis) root 2b Contraindicated in bleeding or very heavy menstruation, first trimester of pregnancy, tendency to spontaneous abortion, acute viral infections such as colds or influenza. (CAACH, 5-6; BSH, 11; PPP, 352; CGBLH, 182) Also contraindicated in diarrhea caused by weak digestion and in hemorrhagic disease. (PPP, 352) Headache may occur in sensitive individuals. (WHO2, 32) Cardiovascular side effects include excessive bleeding. (TCPHP, 290) A case of gynecomastia in a male has been reported. (CGBLH, 182) Dong quai has two furanocoumarins (psoralen and bergapten), which are photoreactive and have the potential to cause severe photodermatitis. These furanocoumarins are also photocarcinogenic. However, the risk of phototoxicity in humans from ingestion of dong quai has not been characterized. (TCPHP, 290-291) Based on animal studies, caution is advised for patients receiving chronic treatment with anticoagulant drugs such as Coumadin (warfarin). (PPP, 352) Refer to the MediHerb Herb-Drug Interactions chart. Echinacea Premium Blend 1:2 Quantified Activity Contraindicated in known allergy to plants of the daisy family. Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Echinacea Echinacea purpurea root Echinacea Echinacea angustifolia root Note: 1 1 Commission E cautioned that Echinacea pallida root should not be used in systemic diseases such as tuberculosis, leukosis, collagenosis, multiple sclerosis, AIDS, HIV infections, and other autoimmune diseases (based on theoretical considerations and not on any reports of adverse findings). Other authoritative sources do not support these restrictions. (TGHM, 121; PPP, 359-360) Should not be administered to patients with known allergy to any plant of Asteraceae (Compositae). (ESCOPM, 137) Allergic reactions, mainly contact dermatitis, may occur rarely in susceptible patients from Echinacea aerial parts. The likelihood of Echinacea root preparations causing allergy is very low. (CGBLH, 185) None known. (ESCOPM, 137; PPP, 360) Caution is advised for transplant patients taking immunosuppressive drugs, short-term therapy only is suggested. (PPP, 360; CGBLH, 185) Commission E cautioned that Echinacea pallida root and E. angustifolia herb and root should not be used in systemic diseases such as tuberculosis, leukosis, collagenosis, multiple sclerosis, AIDS, HIV infections, and other autoimmune diseases (based on theoretical considerations and not on any reports of adverse findings). Other authoritative sources do not support these restrictions. (HM, 94; TGHM, 121, 328; PPP, 359-360) Allergic reactions, mainly contact dermatitis, may occur rarely in susceptible patients from Echinacea aerial parts. The likelihood of Echinacea root preparations causing allergy is very low. (CGBLH, 185) None known. (HM, 95; PPP, 360) Caution is advised for transplant patients taking immunosuppressive drugs, short-term therapy only is suggested. (PPP, 360; CGBLH, 185) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 Refer to the MediHerb Herb-Drug Interactions chart. Refer to the MediHerb Herb-Drug Interactions chart. The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 59 Contraindications and Cautions Liquid Extracts Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Echinacea Purpurea 1:2 Quantified Activity Contraindicated in known allergy to plants of the daisy family. Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Echinacea Echinacea purpurea root 1 Commission E cautioned that Echinacea pallida root should not be used in systemic diseases such as tuberculosis, leukosis, collagenosis, multiple sclerosis, AIDS, HIV infections, and other autoimmune diseases (based on theoretical considerations and not on any reports of adverse findings). Other authoritative sources do not support these restrictions. (TGHM, 121; PPP, 359-360) Should not be administered to patients with known allergy to any plant of Asteraceae (Compositae). (ESCOPM, 137) Allergic reactions, mainly contact dermatitis, may occur rarely in susceptible patients from Echinacea aerial parts. The likelihood of Echinacea root preparations causing allergy is very low. (CGBLH, 185) None known. (ESCOPM, 137; PPP, 360) Caution is advised for transplant patients taking immunosuppressive drugs, short-term therapy only is suggested. (PPP, 360; CGBLH, 185) Refer to the MediHerb Herb-Drug Interactions chart. Echinacea Purpurea 1:3 Glycetract Contraindicated in known allergy to plants of the daisy family. Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Echinacea Echinacea purpurea root 1 Commission E cautioned that Echinacea pallida root should not be used in systemic diseases such as tuberculosis, leukosis, collagenosis, multiple sclerosis, AIDS, HIV infections, and other autoimmune diseases (based on theoretical considerations and not on any reports of adverse findings). Other authoritative sources do not support these restrictions. (TGHM, 121; PPP, 359-360) Should not be administered to patients with known allergy to any plant of Asteraceae (Compositae). (ESCOPM, 137) Allergic reactions, mainly contact dermatitis, may occur rarely in susceptible patients from Echinacea aerial parts. The likelihood of Echinacea root preparations causing allergy is very low. (CGBLH, 185) None known. (ESCOPM, 137; PPP, 360) Caution is advised for transplant patients taking immunosuppressive drugs, short-term therapy only is suggested. (PPP, 360; CGBLH, 185) Refer to the MediHerb Herb-Drug Interactions chart. Eleuthero 1:2 Standardized Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Discontinue during an acute infection or fever. Eleuthero Eleutherococcus senticosus root Note: 1 Contraindicated in acute phase of infections, (PPP, 142, 539) pregnancy, lactation and in cases of known allergy to plants of the Araliaceae family. (WHO2, 91) Commission E noted a contraindication for hypertension. (HM, 107; PPP, 539; TGHM, 125) Two clinical studies recommend that Eleutherococcus not be administered to patients with high blood pressure (HM, 107; TGHM, 62; BSH, 45), although a causal relationship to the use of Eleutherococcus could not be established. (ESCOPM, 142) Caution is advised in cardiovascular disorders. (CGBLH, 195) Insomnia, palpitations, tachycardia and hypertension have been rarely observed in association with clinical studies. (BSH, 45; CGBLH, 195) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 None known. (HM, 108; TGHM, 125; PPP, 539; ESCOPM, 143) Reports that the herb may increase serum digoxin levels, but not conclusive (PPP, 539) and the identity of the plant material as Eleutherococcus was not established. (WHO2, 91) Refer to the MediHerb Herb-Drug Interactions chart. The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 60 Contraindications and Cautions Liquid Extracts Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Eyebright 1:2 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Eyebright Euphrasia officinalis herb 1 No contraindications noted. (PPP, 376; CGBLH, 203) None known. (TGHM, 330; PPP, 376; CGBLH, 202) Garlic 1:1 Contraindicated in known allergy to Garlic. Contraindicated in lactation. Not to be used during pregnancy unless otherwise directed by a qualified health care professional. Garlic Allium sativum bulb 2c Contraindication with gastrointestinal disturbance; in rare instances, there may be changes to the flora of the intestine, or allergic reactions. (TGHM, 134; HM, 145; BSH, 6; BHC, 106) Fresh garlic, extracts or oil may also cause heartburn, nausea, vomiting, and diarrhea if taken on an empty stomach. (WHO1, 26) Garlic intake should be discontinued 10 days before surgery. (PPP, 200) May increase the risk of postoperative bleeding. (WHO1, 25; ESCOPM, 15; AEHD3, 229) Contact allergy is noted. (AEHD1, 74; WHO1, 26) Hematologic concern based upon in vitro data and case reports for garlic and garlic oil. [Editor’s note: the results of case reports are conflicting.] (TCPHP, 110, 111, 301) None known. (TGHM, 134) Garlic’s antiplatelet effect might be dangerous in patients taking warfarin or antiplatelet agents such as aspirin, ticlopidine, clopidogrel, or dipyridamole. (TCPHP, 118; HM, 115; WHO1, 25) An interaction has been observed in two patients taking warfarin. (ESCOPM, 15) Refer to the MediHerb Herb-Drug Interactions chart. Ginger 1:2 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Ginger Zingiber officinale rhizome 2b, 2d Contraindicated with gallstones; consult a physician first. (HM, 156; BSH, 125; TGHM, 136) May increase the chance of bleeding. (PPP, 401) A daily dose of 2 g of dried ginger should not be exceeded in pregnancy. Use with caution in cases of peptic ulceration, gastroesophageal reflux, or other gastric diseases. At doses approaching or greater than the maximum recommended dose, an increase in gastric secretory activity leading to heartburn is possible. (CGBLH, 227) Overdose may lead to a blood-thinning effect and an increase in gastric secretory activity leading to heartburn. (PPP, 401; ESCOPM, 548) Topical application may cause contact dermatitis in sensitive patients. (PPP, 401) None known. (HM, 156; TGHM, 136) May increase the absorption of pharmaceutical drugs. (PPP, 401) Caution indicated for daily doses of (dried) ginger in excess of 4 g with patients taking blood-thinning drugs such as warfarin, or aspirin or who have increased risk of hemorrhage. (PPP, 401; TCPHP, 129; CAACH, 106; CGBLH, 227) May enhance absorption of sulphaguanidine. (ESCOPM, 548) Refer to the MediHerb Herb-Drug Interactions chart. Ginkgo 2:1 Standardized Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Ginkgo Ginkgo biloba leaf Note: 2d Adverse reactions: headaches, mild gastrointestinal disturbances, and allergic skin reactions are possible. (WHO1, 163; PPP, 414; TGHM, 138; HM, 166; AEHD3, 59; BSH, 57; ESCOPM, 179) Contraindicated in hypersensitivity or intolerance to Ginkgo preparations. (TGHM, 137; WHO1, 162; ESCOPM, 179) Hematologic and neurologic concern based on case reports. (TCPHP, 301) Isolated episodes of spontaneous bleeding have been reported. (CGBLH, 233) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 None known. (TGHM, 138; WHO1, 163) Caution should be exercised when prescribing Ginkgo with warfarin or aspirin. (PPP, 414; HM, 167) (Although no interactions with substances that inhibit blood coagulation have been observed in controlled studies. (ESCOPM, 179)) The effect of plateletaggregation inhibitors may be increased. (HM, 167) Refer to the MediHerb Herb-Drug Interactions chart. The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 61 Contraindications and Cautions Liquid Extracts Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Globe Artichoke 1:2 Contraindicated in closure of the gallbladder. Use only with professional supervision in gallstones. Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Globe Artichoke Cynara scolymus leaf No information. Contraindicated in closure of the gallbladder (PPP, 437) None known. (PPP, 437; TGHM, 85; HM, 11; ESCOPM, or obstruction of bile duct. (ESCOPM, 119). Precautions 119; CGBLH, 240) with known allergies to artichoke and similar plants (Compositae family). The likelihood of allergy is very low, no cases of allergy reaction after oral intake have been reported. (TGHM, 84; HM, 11; ESCOPM, 119; CGBLH, 240) Use only with professional supervision in cholelithiasis. (PPP, 437; HM, 11; ESCOPM, 119) As with other members of the Compositae family, contact with fresh plant can cause contact dermatitis. (PPP, 438) Mild gastrointestinal disturbances may occur in rare cases; allergic reactions might occur in sensitized patients. (ESCOPM, 119) Golden Seal 1:3 Quantified Activity Contraindicated in pregnancy and lactation. Contraindicated in patients with high blood pressure. Golden Seal Hydrastis canadensis root & rhizome 2b Contraindicated in hypertensive conditions, pregnancy Berberine, an alkaloid constituent of this herb, may and jaundiced neonates (PPP, 294; CGBLH, 250) Fresh reinforce the effects of other drugs which displace plant may cause irritation to the mucosa. (BSH, 62) the protein binding of bilirubin. (PPP, 295) Canadian regulations do not allow golden seal as a nonmedicinal ingredient for oral use products. (BSH, 62) Gotu Kola 1:1 Standardized Contraindicated in known allergy to Gotu Kola. Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Gotu Kola Centella asiatica herb 1 None known. (WHO1, 83; CGBLH, 254) Canadian regulations do not allow the herb as a nonmedicinal ingredient for oral use products. (BSH, 26) Allergic contact dermatitis has been associated with topical application, but it is a low risk. Further testing revealed that these reactions may be due to other ingredients in the preparations. (WHO1, 83; CGBLH, 255) Contraindicated in known allergy and allergy to plants of the Umbelliferae (carrot) family. (WHO1, 82; CGBLH, 254) Gymnema 1:1 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Gymnema Gymnema sylvestre leaf No information. Since it contains saponins, this herb may be a gastrointestinal irritant. (PPP, 46) None known. (CGBLH, 267) [Editor’s note: Particular care should be exercised where the patient is taking insulin or oral hypoglycemic drugs.] Refer to the MediHerb Herb-Drug Interactions chart (under Hypoglycemic herbs). Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 62 Contraindications and Cautions Liquid Extracts Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Hawthorn Berries 1:2 Quantified Activity Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Hawthorn Crataegus monogyna fruit 1 A physician must be consulted in cases where symptoms continue unchanged for longer than six weeks or when fluid accumulates in the legs. Medical diagnosis is absolutely necessary when pains occur in the region of the heart, spreading out to the arms, upper abdomen or the area around the neck, or in cases of respiratory distress (shortness of breath). (TGHM, 143; ESCOPM, 99; WHO2, 77) In 1997, it was noted that in Canada, the herb carries new drug status and is not approved, as self-treatment of cardiovascular conditions is deemed inappropriate. (TCPHP, 257) Hawthorn preparations may have a potentiating effect which may necessitate a smaller dosage of digitalis,(PPP, 446; BSH, 37) though this action has not been confirmed. (HM, 186) Hawthorn preparations may act in synergy with beta-blockers and other hypotensive drugs. Modification of drug dosage may be required. (PPP, 446; CGBLH, 270; TCPHP, 257) Refer to the MediHerb Herb-Drug Interactions chart (under Hawthorn and Tannin- or OPC-containing herbs). Horsechestnut 1:2 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. May cause gastric upset in some patients. Do not apply to broken or ulcerated skin. Horsechestnut Aesculus hippocastanum seed No information. Contraindicated in known allergy to plants of the Hippocastanaceae family. (WHO2, 144) Adverse effects reported to include pruritis, nausea, and gastric complaints in isolated cases after oral intake. (HM, 203; ESCOPM, 249; WHO2, 145) Oral use may cause irritation of the gastric mucous membranes and reflux. Saponins may cause hemolysis, but this effect is negligible at the oral doses commonly used. (PPP, 454) Horsechestnut should not be applied to broken or ulcerated skin. (PPP, 454) Allergic reactions have been reported from topical use of the active constituent escin. (WHO2, 145) None known. (HM, 203; PPP, 454; ESCOPM, 249; CGBLH, 281) Horsetail 1:2 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Horsetail Equisetum arvense herb Note: 2d Contraindicated in cardiac or renal dysfunction. (BSH, 47; BHC, 93) Products sold in Canada are required to be certified as free from any thiaminase-like effect. (BSH, 47) Powdered herb not recommended for children or prolonged use. (BSH, 48) Toxicity is reported to be similar to nicotine poisoning in children who chewed the stem. (BSH, 48) Classified as an herbal diuretic, may be inappropriate or possibly even contraindicated in renal failure and diabetes. (PPP, 222) No irrigation therapy (copious fluid intake) in case of edema due to impaired heart and kidney function. (TGHM, 151; HM, 209) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 None known. (TGHM, 151; HM, 210; CGBLH, 285) The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 63 Contraindications and Cautions Liquid Extracts Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Korean Ginseng 1:2 Standardized Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Discontinue during an acute infection or fever. Korean Ginseng Panax ginseng main root 2d Contraindicated for hypertension. (BSH, 81; HM, 174; CGBLH, 297) Contraindicated with signs of heat, acute infections, acute asthma, hypertension, excessive menstruation or nose bleeds. (PPP, 429; CAACH, 41) Consuming caffeine with ginseng increases the risk of overstimulation and gastrointestinal upset. (BSH, 81; BHC, 116) Concurrent use with amphetamines should be avoided. (CGBLH, 297) Higher doses can overstimulate and aggravate insomnia, irritability, depression, headache, palpitation, hypertension, and can cause tremor, euphoria, skin eruptions, menstrual abnormalities, diminished sexual function and weight loss. (BSH, 81; CAACH, 40) The use of ginseng is not associated with serious adverse effects if taken at the recommended dose level. (ESCOPM, 212) May cause side effects related to an estrogen-like activity in women. (CGBLH, 298) May reduce blood glucose levels, diabetic patients should consult with physician. (WHO1, 176; ESCOPM, 212) May interact with monoamine oxidase inhibitor phenelzine and also with warfarin, (PPP, 429; WHO1, 176) although studies are needed to verify the potential interaction with warfarin and the underlying mechanism. (ESCOPM, 212) Do not use with stimulants, including excessive use of caffeine. (HM, 174; PPP, 429) Refer to the MediHerb Herb-Drug Interactions chart. Licorice 1:1 Contraindicated in high blood pressure, edema (water retention), congestive heart failure, low blood potassium, pregnancy and lactation. Licorice Glycyrrhiza glabra root 2b, 2c, 2d It is recommended that patients with cardiovascular or renal disease use licorice only under care of health care professional. (TCPHP, 232; PPP, 474) Patients prone to potassium deficiency are also advised not to use licorice. (TCPHP, 232; TGHM, 161) Treatment not to exceed six weeks. (TCPHP, 232; BSH, 58; TGHM, 162) Contraindications: hypertension, cholestatic liver disorders, inflammatory liver disorders, liver cirrhosis, hypertonia, hypokalemia, severe obesity and severe kidney insufficiency (HM, 236; BSH, 58; BHC, 146; TGHM, 161; WHO1, 190; AEHD3, 72; ESCOPM, 298) pregnancy and lactation (ESCOPM, 298). In the case of pregnancy doses up to 3 g per day are likely to be safe. (PPP, 474) Also contraindicated if there is edema or congestive heart failure. (PPP, 474) Caution is advised with elderly patients. (CGBLH, 312) Ingestion of an excessive amount can lead to severe hypertension, cardiac arrhythmias, cardiomyopathy, cardiac arrest, pseudoaldosteronism, myopathy, pulmonary and generalized edema. (AEHD3, 73; BSH, 58; BHC, 146; AEHD3, 72; CGBLH, 313) Should not be taken concurrently with corticosteroid treatment. (WHO1, 190; AEHD3, 77) May decrease plasma clearance and increase the AUC of prednisolone. Licorice may potentiate the activity of prednisolone and other corticosteroid drugs. (ESCOPM, 298; CGBLH, 313) Concurrent use of furosemide may potentiate development of acute renal failure. (AEHD3, 77) Potassium loss due to other drugs, e.g. thiazide diuretics, can be increased. With potassium loss, sensitivity to digitalis glycosides increases. (HM, 237; TGHM, 161; WHO1, 190) Excessive use of licorice may interact with antiarrhythmic drugs or with drugs which induce reversion to sinus rhythm (e.g. quinidine). (ESCOPM, 298) Should not be administered in conjunction with spironolactone or amiloride. (WHO1, 190) Insulin may be synergistic with glycyrrhizin in causing electrolyte disturbances and suppression of renin and aldosterone. (AEHD3, 77) There is a slight chance that licorice may counteract the contraceptive pill, on the basis of the constituent glycyrrhizin. (CGBLH, 312) Refer to the MediHerb Herb-Drug Interactions chart. Note: The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 64 Contraindications and Cautions Liquid Extracts Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Licorice High Grade 1:1 Quantified Activity Contraindicated in high blood pressure, edema (water retention), congestive heart failure, low blood potassium, pregnancy and lactation. Licorice Glycyrrhiza glabra root 2b, 2c, 2d It is recommended that patients with cardiovascular or renal disease use licorice only under care of health care professional. (TCPHP, 232; PPP, 474) Patients prone to potassium deficiency are also advised not to use licorice. (TCPHP, 232; TGHM, 161) Treatment not to exceed six weeks. (TCPHP, 232; BSH, 58; TGHM, 162) Contraindications: hypertension, cholestatic liver disorders, inflammatory liver disorders, liver cirrhosis, hypertonia, hypokalemia, severe obesity and severe kidney insufficiency (HM, 236; BSH, 58; BHC, 146; TGHM, 161; WHO1, 190; AEHD3, 72; ESCOPM, 298) pregnancy and lactation (ESCOPM, 298). In the case of pregnancy doses up to 3 g per day are likely to be safe. (PPP, 474) Also contraindicated if there is edema or congestive heart failure. (PPP, 474) Caution is advised with elderly patients. (CGBLH, 312) Ingestion of an excessive amount can lead to severe hypertension, cardiac arrhythmias, cardiomyopathy, cardiac arrest, pseudoaldosteronism, myopathy, pulmonary and generalized edema. (AEHD3, 73; BSH, 58; BHC, 146; AEHD3, 72; CGBLH, 313) Should not be taken concurrently with corticosteroid treatment. (WHO1, 190; AEHD3, 77) May decrease plasma clearance and increase the AUC of prednisolone. Licorice may potentiate the activity of prednisolone and other corticosteroid drugs. (ESCOPM, 298; CGBLH, 313) Concurrent use of furosemide may potentiate development of acute renal failure. (AEHD3, 77) Potassium loss due to other drugs, e.g. thiazide diuretics, can be increased. With potassium loss, sensitivity to digitalis glycosides increases. (HM, 237; TGHM, 161; WHO1, 190) Excessive use of licorice may interact with antiarrhythmic drugs or with drugs which induce reversion to sinus rhythm (e.g. quinidine). (ESCOPM, 298) Should not be administered in conjunction with spironolactone or amiloride. (WHO1, 190) Insulin may be synergistic with glycyrrhizin in causing electrolyte disturbances and suppression of renin and aldosterone. (AEHD3, 77) There is a slight chance that licorice may counteract the contraceptive pill, on the basis of the constituent glycyrrhizin. (CGBLH, 312) Refer to the MediHerb Herb-Drug Interactions chart. Marshmallow Root 1:5 Glycetract Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Marshmallow Althaea officinalis root 1 As a mucilage or respiratory demulcent, contraindicated Absorption of other drugs taken simultaneously may or at least inappropriate in congestive bronchial, be delayed. (BSH, 9; HM, 245, 247; ESCOPM, 33; catarrhal and congestive conditions of the mucosa. (PPP, TGHM, 166, 167; WHO2, 9; CGBLH, 321) 169, 211) Refer to the MediHerb Herb-Drug Interactions chart. Milk Thistle 1:1 Quantified Activity Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. In anemia and cases where iron supplementation is required, do not take simultaneously with meals or iron supplements. Milk Thistle Silybum marianum seed 1 Contraindicated in cases of known allergy to plants of the Asteraceae (Compositae) family. (WHO2, 310) Side effect: a mild laxative effect and mild gastrointestinal complaints have been observed in occasional instances from the standardized preparation. (HM, 260; TGHM, 170; WHO2, 310; CGBLH, 326) None known. (PPP, 560; HM, 261; TGHM, 170) Refer to the MediHerb Herb-Drug Interactions chart (under Milk Thistle and Polyphenolic- or Flavonoidcontaining herbs). Milk Thistle 1:1 Glycetract Quantified Activity Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. In anemia and cases where iron supplementation is required, do not take simultaneously with meals or iron supplements. Milk Thistle Silybum marianum seed Note: 1 Contraindicated in cases of known allergy to plants of the Asteraceae (Compositae) family. (WHO2, 310) Side effect: a mild laxative effect and mild gastrointestinal complaints have been observed in occasional instances from the standardized preparation. (HM, 260; TGHM, 170; WHO2, 310; CGBLH, 326) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 None known. (PPP, 560; HM, 261; TGHM, 170) Refer to the MediHerb Herb-Drug Interactions chart (under Milk Thistle and Polyphenolic- or Flavonoidcontaining herbs). The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 65 Contraindications and Cautions Liquid Extracts Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Mistletoe 1:2 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Mistletoe Viscum album herb 2d Canadian regulations do not allow European mistletoe in foods. (BSH, 123) None known. (TGHM, 172; CGBLH, 329) Motherwort 1:2 Contraindicated in pregnancy. Contraindicated during lactation unless otherwise directed by a qualified health care professional. Motherwort Leonurus cardiaca herb 2b Best avoided in early pregnancy. (CGBLH, 331) Excess dosage may cause diarrhea, uterine bleeding, and stomach irritation. (BSH, 69) None known. (TGHM, 172; HM, 268; CGBLH, 331) Nettle Leaf 1:2 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Nettle Urtica dioica leaf 1 Contraindication: patients who are allergic to nettle stings should not apply the fresh or unprocessed dried leaves topically. (PPP, 496) Irrigation therapy (copious fluid intake) is not advised if edema exists due to impaired heart or kidney function. (TGHM, 216) Occasional (rare) allergic reactions have been observed. (BHC, 166) None known. (TGHM, 216; ESCOPM, 522; CGBLH, 343) Nettle Root 1:2 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. The National Institute on Aging recommends that men get regular medical checkups with a thorough prostate exam. Nettle Urtica dioica root None known. (TGHM, 217; ESCOPM, 529) No information. Contraindicated in known allergy to plants of the Urticaceae family. (WHO2, 337) Commission E advises that nettle root is useful for the problems associated with an enlarged prostate. However, they advise that its use for BPH should occur under professional supervision. (PPP, 496) Difficulties in micturition require at all times clarification by a physician; consultation with a physician is necessary especially in cases blood in the urine and acute urine retention. (ESCOPM, 529) May cause mild gastrointestinal trouble and allergic skin reactions (rarely). (PPP, 496; TGHM, 216; ESCOPM, 529; WHO2, 338) Oats Seed 1:1 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Oats Avena sativa seed Note: 1 Risks of adverse effects only in those patients with extremely debilitated constitutions. (PPP, 234) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 None known. (HM 282; TGHM, 176; BSH, 18; CGBLH, 349) The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 66 Contraindications and Cautions Liquid Extracts Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Oregon Grape 1:2 Contraindicated in pregnancy and lactation. Oregon Grape Berberis aquifolium (Mahonia aquifolium) root 2b Berberine, an alkaloid constituent of this herb, may Canadian regulations require bilingual label warning potentiate other drugs which displace the protein against use in pregnancy and is an unacceptable nonbinding of bilirubin. (PPP, 295) medicinal ingredient in oral use products. (BSH, 73) Contraindicated in pregnancy, and jaundiced neonates. (CGBLH, 80) This herb is classified as a choleretic and cholagogue. It is either contraindicated or at least inappropriate in the following: (1) obstructed bile ducts, (2) unconjugated hyperbilirubinemia, (3) acute or severe hepatocellular disease, (4) septic cholecystitis (where there is risk of peritonitis), (5) intestinal spasm or ileus, and (6) liver cancer. (PPP, 187) As an alterative, this herb may be provocative to skin disease, and care needs to be taken to reduce the prospects of exacerbations. (PPP, 254) Pau d’Arco 1:2 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Contraindicated in patients taking anticoagulant drugs. Pau d’Arco Tabebuia avellanedae bark 1 Contraindicated with anticoagulants. (PPP, 504) Adverse effects are not expected when consumed with the recommended dosage. (PPP, 500) Caution is advised in pregnancy. (CGBLH, 366) Patients on anticoagulant therapy should not be prescribed pau d’arco due to the warfarin-like action of naphthoquinones at high doses. (PPP, 504) Refer to the MediHerb Herb-Drug Interactions chart. Poke Root 1:5 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Contraindicated in lymphocytic leukemia and gastrointestinal irritation. Poke Root Phytolacca decandra root 3 None known. (PPP, 517) Concurrent use with Contraindications: pregnancy, lactation, lymphocytic immunosuppressive drugs should be avoided. leukemia and gastrointestinal irritation. (PPP, 517; CGBLH, 376) Toxic effects from large doses may include (CGBLH, 376) nausea, vomiting, profuse sweating and salivation. (PPP, 517; AEHD2, 255-256) Accurate measurement of dried plant tincture volumes is vital to ensure that the safe dosage is not exceeded. (CGBLH, 376) Topical application of herb should be restricted to dried plant tinctures and the eyes should be avoided. (PPP, 517; CGBLH, 376) Possible cardiovascular effects: muscle weakness and spasms; possible neurological effects: headache, dizziness, tremor, confusion, and dyspnea, and diarrhea have been reported. (TCPHP, 239) Canadian regulations do not allow poke root in foods. (BSH, 85) Several case reports indicate contraindication with cardiac conditions. (AEHD2, 257; PPP, 516) Red Clover 1:2 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Red Clover Trifolium pratense flower Note: 2b May be provocative to skin disease. Care needs to be taken to reduce the prospects for major exacerbations. (PPP, 255) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 None known. (CGBLH, 384) The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 67 Contraindications and Cautions Liquid Extracts Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Rehmannia 1:2 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Rehmannia Rehmannia glutinosa root 2d Contraindicated with diarrhea and indigestion. (BSH, 95) None known. (PPP, 521; CGBLH, 386) Side effects may include mild diarrhea, abdominal pain, dizziness, lack of energy, palpitations and edema. (BSH, 95; PPP, 521) Sage 1:2 Quantified Activity Contraindicated in pregnancy. Contraindicated during lactation unless otherwise directed by a qualified health care professional. Sage Salvia officinalis herb 2b, 2d Leaf and essential oil are contraindicated in pregnancy and lactation. (CGBLH, 394; TGHM, 198) After prolonged ingestion of alcohol extracts or of the pure essential oil, epileptiform convulsions can occur. (HM, 332; TGHM, 198) Caution is advised with the use of alcoholic preparations and the pure essential oil because of the presence of thujone. (ESCOPM, 453; HM, 332; TGHM, 198) Do not exceed the recommended dose, take with caution if using long term. (CGBLH, 394) None known. (HM, 332; ESCOPM, 453; TGHM, 198; BSH, 102; CGBLH, 394) Refer to the MediHerb Herb-Drug Interactions chart (under Tannin- or OPC-containing herbs). Sarsaparilla 1:2 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Sarsaparilla Smilax ornata root & rhizome 1 Risks: taking the herb may lead to gastric irritation and temporary kidney impairment (diuresis). The absorption of simultaneously administered substances may be increased. The elimination of other substances (e.g., hypnotics) is accelerated. This can cause an uncontrolled condition of increased or decreased action of herbs taken simultaneously. (TGHM, 372) These concerns are theoretical, and not established by animal studies or case reports. (CGBLH, 397) Commission E advises of potential drug interactions with hypnotics, digitalis glycosides, and bismuth. However, no other reference substantiates these concerns. (BSH, 108) Such concerns would be alleviated by not taking sarsaparilla simultaneously with drug medication. (CGBLH, 397) Saw Palmetto 1:2 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. The National Institute on Aging recommends that men get regular medical checkups with a thorough prostate exam. Saw Palmetto Serenoa repens fruit 1 None known. (HM, 338; TGHM, 201; PPP, 530; Stomach problems or gastrointestinal distress in rare ESCOPM, 478; CGBLH, 400) cases. (HM, 338;TGHM, 201; BSH, 107; ESCOPM, 478) Commission E suggests regular consultation with a physician when using this herb for treatment of enlarged prostate. This caution is based on assumption that this herb treats only symptoms without eliminating hypertrophic concerns. (BSH, 107) No adverse effects are expected if used as recommended. (PPP, 524) Schisandra 1:2 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Schisandra Schisandra chinensis fruit Note: 1 Contraindicated in pregnancy, except to assist childbirth; in the early stages of cough or rash and in excess heat patterns. (CGBLH, 405) May be contraindicated in liver carcinoma. (PPP, 192) Rare side effects of appetite suppression, stomach upset, and urticaria are reported. (BSH, 104) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 None known. (CGBLH, 405) Refer to the MediHerb Herb-Drug Interactions chart. The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 68 Contraindications and Cautions Liquid Extracts Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Skullcap 1:2 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Skullcap Scutellaria lateriflora herb 1 None known. (CGBLH, 415) May be contraindicated in depression and insomnia marked by increasing restlessness during the early hours of the morning. (PPP, 233) High doses may cause giddiness, stupor, confusion, twitching, arrhythmias, and epilepsy. (TCPHP, 218) Reports of toxicity are likely due to adulteration with germander. (BSH, 105) St John’s Wort 1:2 Quantified Activity Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Do not use this product while taking any prescription drug(s) without the advice of your prescribing physician. Avoid excessive exposure to UV irradiation (e.g. sunlight, tanning) when using this product. St John’s Wort 2d Hypericum perforatum flowering herb Note: Contraindicated in the treatment of serious depression with psychotic symptoms, suicidal risk or signs and symptoms that are so severe that they do not allow the patient’s family or work involvements to continue. (PPP, 549; ESCOPM, 259) Not to be taken after organ transplants. (ESCOPM, 258) Contraindicated in known photosensitivity and known allergy to plants of the Clusiaceae family. (WHO2, 163; CGBLH, 420) May cause mild stomach discomfort, skin rash, tiredness, fatigue, headache, sleep disturbances. Photosensitization is possible after exposure to sunlight and especially in fair skinned individuals. (BSH, 62; TGHM, 215; HM, 363; PPP, 548; ESCOPM, 259; WHO2, 163) Patients taking higher doses should avoid excessive exposure to sunlight and UV radiation. (CGBLH, 420) Caution advised in very severe debility, especially if associated with immune or digestive collapse, renal or hepatic failure, rampant cancer or strong regimes of chemotherapy. (PPP, 155) Dermatologic and neurologic concern based upon case reports. (TCPHP, 301) Side effects are rare and mild, and include minor gastrointestinal irritations, allergic reactions, tiredness and restlessness. (WHO2, 165) Mild, reversible elevations of serum liver enzymes noted in HIV-positive patients. Mania has been noted as a side effect but has not been conclusively linked to use of the herb. Avoid use of preparations made from herb harvested at the onset of full flowering, and avoid dispensing the sediment from liquid extracts – the resinous compounds contained therein may cause sensory nerve hypersensitivity. (CGBLH, 422) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 None known. (TGHM, 215; HM, 363) May potentiate pharmaceutical MAO-inhibitors. (BSH, 62, 173) Recommend physician consultation when taken with MAO inhibitors, SSRIs, and tricyclics (PPP, 549) Reduced blood levels have been reported with respect to cyclosporin, indinavir and potentially other antiretroviral protease and transcriptase inhibitors, the anticoagulants phenprocoumon and warfarin, theophylline and digoxin. It remains an open question whether St John’s wort preparations also interact with oral contraceptives, particularly low dose contraceptives (<50 mcg of estrogen). (ESCOPM, 259) Contraindicated in patients taking irinotecan. No clinical adverse effects have been reported for phenytoin or any other anticonvulsant drug. (CGBLH, 421) Refer to the MediHerb Herb-Drug Interactions chart (under St John’s Wort and Tannin- or OPC-containing herbs). The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 69 Contraindications and Cautions Liquid Extracts Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs St John’s Wort High Grade 1:2 Quantified Activity Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Do not use this product while taking any prescription drug(s) without the advice of your prescribing physician. Avoid excessive exposure to UV irradiation (e.g. sunlight, tanning) when using this product. St John’s Wort 2d Hypericum perforatum flowering herb Contraindicated in the treatment of serious depression with psychotic symptoms, suicidal risk or signs and symptoms that are so severe that they do not allow the patient’s family or work involvements to continue. (PPP, 549; ESCOPM, 259) Not to be taken after organ transplants. (ESCOPM, 258) Contraindicated in known photosensitivity and known allergy to plants of the Clusiaceae family. (WHO2, 163; CGBLH, 420) May cause mild stomach discomfort, skin rash, tiredness, fatigue, headache, sleep disturbances. Photosensitization is possible after exposure to sunlight and especially in fair skinned individuals. (BSH, 62; TGHM, 215; HM, 363; PPP, 548; ESCOPM, 259; WHO2, 163) Patients taking higher doses should avoid excessive exposure to sunlight and UV radiation. (CGBLH, 420) Caution advised in very severe debility, especially if associated with immune or digestive collapse, renal or hepatic failure, rampant cancer or strong regimes of chemotherapy. (PPP, 155) Dermatologic and neurologic concern based upon case reports. (TCPHP, 301) Side effects are rare and mild, and include minor gastrointestinal irritations, allergic reactions, tiredness and restlessness. (WHO2, 165) Mild, reversible elevations of serum liver enzymes noted in HIV-positive patients. Mania has been noted as a side effect but has not been conclusively linked to use of the herb. Avoid use of preparations made from herb harvested at the onset of full flowering, and avoid dispensing the sediment from liquid extracts – the resinous compounds contained therein may cause sensory nerve hypersensitivity. (CGBLH, 422) None known. (TGHM, 215; HM, 363) May potentiate pharmaceutical MAO-inhibitors. (BSH, 62, 173) Recommend physician consultation when taken with MAO inhibitors, SSRIs, and tricyclics (PPP, 549) Reduced blood levels have been reported with respect to cyclosporin, indinavir and potentially other antiretroviral protease and transcriptase inhibitors, the anticoagulants phenprocoumon and warfarin, theophylline and digoxin. It remains an open question whether St John’s wort preparations also interact with oral contraceptives, particularly low dose contraceptives (<50 mcg of estrogen). (ESCOPM, 259) Contraindicated in patients taking irinotecan. No clinical adverse effects have been reported for phenytoin or any other anticonvulsant drug. (CGBLH, 421) Refer to the MediHerb Herb-Drug Interactions chart (under St John’s Wort and Tannin- or OPC-containing herbs). Tienchi Ginseng 1:2 Contraindicated in pregnancy. Contraindicated during lactation unless otherwise directed by a qualified health care professional. Tienchi Ginseng Panax notoginseng root 2b Contraindicated in pregnancy. (CAACH,45; CGBLH, 433) None known. (BSH, 82; CGBLH, 433) Turmeric 1:1 Contraindicated in pregnancy. Contraindicated during lactation unless otherwise directed by a qualified health care professional. Contraindicated in closure of the gallbladder. Use only with professional supervision in gallstones. Turmeric Curcuma longa rhizome Note: 2b, 2d Contraindicated in obstruction of bile passages; in case of gallstones, use only after consulting with a physician. (TGHM, 222; HM, 382; WHO1, 121; PPP, 578; ESCOPM, 107) The herb should not be administered to patients who suffer from stomach ulcers or hyperacidity. (BSH, 39; HM, 382) Occasional cases of allergic dermatitis reported. (WHO1, 121; PPP, 578) Care should be exercised with women wishing to conceive and patients complaining of hair loss. (CGBLH, 436) Patients applying topical doses should be cautioned against excessive exposure to sunlight. (PPP, 578) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 None known. (HM, 382; TGHM, 222; ESCOPM, 108) High doses (>15 g/day) should not be given to patients taking antiplatelet or anticoagulant drugs. (PPP, 578; CGBLH, 436) Refer to the MediHerb Herb-Drug Interactions chart. The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 70 Contraindications and Cautions Liquid Extracts Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Uva Ursi 1:2 Contraindicated in pregnancy and lactation. Not suitable for prolonged use. Uva Ursi Arctostaphylos uva-ursi leaf 2b, 2d Large doses may cause nausea and vomiting. (HM, 391; BHC, 212) May also cause cramping and constipation, due to high tannin content. Not suitable for longterm use. (PPP, 284; ESCOPM, 536; CGBLH, 444) Contraindications: kidney disorders, renal failure, which may be theoretical, and pregnancy. (BHC, 212; PPP, 223, 284; BSH, 13; ESCOPM, 536-537) Should not be given with treatments that will lead to the production of acidic urine (leading to a reduction of antibacterial effect). The high tannin content could interfere with the absorption of some nutrients. (CGBLH, 444) Refer to the MediHerb Herb-Drug Interactions chart (under Tannin- or OPC-containing herbs). Valerian 1:2 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Valerian Valeriana officinalis root 1 Can aggravate a sensation of tiredness or drowsiness, particularly in higher doses. (PPP, 587; WHO1, 273) Overdose can result in blurred vision, erratic heart beat, headache, nausea, restlessness, visual illusions, even spasmodic movements. (PPP, 588; BSH, 120) Very large doses may cause bradycardia and arrhythmias, and decrease intestinal motility. (WHO1, 274) Canada allows products containing valerian for use as sleeping aids and sedatives. (TCPHP, 64) Hepatic and neurologic concern based upon case reports, although in the case of alleged hepatotoxicity coingestants were involved. (TCPHP, 301) None known. (TGHM, 226; ESCOPM, 540; HM, 397) May increase the effects of CNS depressants or alcohol when taken together, (PPP, 587; AEHD3, 172; WHO1, 273) although human studies indicate that this is unlikely for alcohol. (CGBLH, 447) The herb may be expected to have at least an additive effect with barbiturates, alcohol, benzodiazepines, and other CNS depressants. (TCPHP, 64) Refer to the MediHerb Herb-Drug Interactions chart. White Peony 1:2 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. White Peony Paeonia lactiflora root 1 Consult with a physician when patient has breast cancer condition. (PPP, 244) The herb reduces testosterone production from ovaries but not from adrenal glands. (CAACH, 31) None known. (CGBLH, 458) Should not be combined with Fritillaria verticillata, Cuscuta japonica and Rheum officinale. (WHO1, 199) Caution should be exercised when used with estrogenic drugs or anticoagulant drugs. (PPP, 244; CGBLH, 458) Wild Yam 1:2 Quantified Activity Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Wild Yam Dioscorea villosa root & rhizome Note: 1 Large doses produce emesis. (BSH, 42) Oral use may cause irritation of the gastric mucous membranes and reflux. (CGBLH, 464) Also classified as choleretic and cholagogue, the herb is either contraindicated or at least inappropriate in the following: (1) obstructed bile ducts, (2) unconjugated hyperbilirubinemia, (3) acute or severe hepatocellular disease, (4) septic cholecystitis (where there is risk of peritonitis), (5) intestinal spasm or ileus, and (6) liver cancer. (PPP, 187) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 None known. (CGBLH, 464) Consult physician when patient is being treated with estrogen-promoting drugs. (PPP, 46, 245) The herb is contraindicated or at least inappropriate when there is already prescription of strong anti-inflammatory medication. (PPP, 149) The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 71 Contraindications and Cautions Liquid Extracts Product and Ingredient Name Class Contraindications, Cautions and Potential Adverse Reactions Interactions with Drugs Wormwood 1:5 Contraindicated in pregnancy and lactation. Wormwood Artemisia absinthium herb 2b, 2c, 2d None known. (BSH, 15; TGHM, 233; ESCOPM, 4; Contraindications: gastric and duodenal ulcers, pregnancy, lactation, hyperacidity, known sensitivity to CGBLH, 469) wormwood or other members of the Compositae family. (ESCOPM, 4; CGBLH, 469) The toxicological risk from use of conventional wormwood preparations is considered to be very low. (ESCOPM, 4) The recommended dosage range must not be exceeded. (CGBLH, 469) As a bitter, this herb is contraindicated or at least inappropriate in duodenal ulceration and conditions involving dry cough and some kidney diseases. (PPP, 173) Wormwood contains approximately 1.5–1.7% essential oil which contains a neurotoxin called thujone. In toxic doses, thujone acts as a convulsant poison. Therefore, the pure essential oil must not be used. (TGHM, 233; BSH, 158) Regulatory restrictions require finished food products to be thujone-free in the U.S. and other countries. (BSH, 15) Toxicological concern not indicated, except in long term use. (BSH, 15) Yellow Dock 1:2 Not to be used during pregnancy and lactation unless otherwise directed by a qualified health care professional. Yellow Dock Rumex crispus root Note: 2d Use with caution in pregnancy. (CGBLH, 474) Contraindicated or at least inappropriate in constipation associated with bowel irritability, bowel disease, diarrhea. (PPP, 173) Individuals with a history of kidney stones should use cautiously. (BSH, 100) The information presented herein has not been confirmed or agreed to by MediHerb or Standard Process. Some information is based on in vitro data and case reports that have not been substantiated by clinical studies. This compilation of information and references is presented for the convenience of practitioners who are encouraged to review the source literature. Sources: AEHD1 = Adverse Effects of Herbal Drugs Vol. 1, AEHD2 = Adverse Effects of Herbal Drugs Vol. 2, AEHD3 = Adverse Effects of Herbal Drugs Vol. 3, BHC = British Herbal Compendium, BSH = Botanical Safety Handbook, CAACH = Clinical Applications of Ayurvedic and Chinese Herbs, CGBLH = Clinical Guide to Blending Liquid Herbs, EOS = Essential Oil Safety: A Guide for Health Care Professionals, ESCOPM = European Scientific Cooperative on Phytotherapy Monographs, HM = Herbal Medicine, PPP = Principles and Practice of Phytotherapy, TGHM = Therapeutic Guide to Herbal Medicines, TCPHP = Toxicology and Clinical Pharmacology of Herbal Products, WHO1 = World Health Organization Monographs on Selected Medicinal Plants, Volume 1, WHO2 = World Health Organization Monographs on Selected Medicinal Plants, Volume 2 None known. (CGBLH, 474) Refer to the MediHerb Herb-Drug Interactions chart. The herb classification found in the Botanical Safety Handbook are defined: Class 1 = Herbs that can be safely consumed when used appropriately. Class 2 = Herbs for which the following use restrictions apply: (2a) for external use only; (2b) not to be used during pregnancy; (2c) not to be used while nursing; (2d) other specific use restrictions as noted. Class 3 = Herbs for which significant data exist to recommend the following labeling: “To be used only under the supervision of an expert qualified in the appropriate use of this substance.” Labeling must include proper use information: dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of this substance. Class 4 = Herbs for which insufficient data are available for classification. 72