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March 2013 Volume 5 Issue 2 Express Scripts Drug Information & Wellness Center Drug Information Updates In the News: New Recommendation: No Daily Vitamin D/Calcium Postmenopause There is insufficient evidence to support the use of vitamin D and calcium supplementation to prevent fractures in community-dwelling men and premenopausal women without decreased bone mineral density. In 2 systematic reviews and a meta-analysis, vitamin D and calcium supplementation had no effect on the frequency of bone fractures among community-dwelling adults. The Women’s Health Initiative (WHI) reported a slightly increased risk for nephrolithiasis associated with vitamin D and calcium supplementation in a trial with 36,282 healthy postmenopausal women. The US Preventive Services Task Force (USPSTF) encourages clinicians to think carefully before recommending vitamin D and calcium supplementation for healthy patients. Azithromycin Poses Fatal Cardiac Risk, FDA Warns FDA warrants a careful screening of patients for azithromycin due to the risk of potentially fatal irregular heart rhythm. Patients at risk for azithromycin-induced arrhythmia include individuals who already have a prolonged QT interval, low blood levels of potassium or magnesium, abnormally slow heart rate, or take drugs to treat arrhythmias. The announcement follows a study that reported a small, increased risk for sudden cardiac death in patients taking a 5-day course of azithromycin compared to patients taking amoxicillin or no antibiotics. The label of azithromycin has been updated to warn of the risk for QT interval prolongation and torsades de pointes. Special points of interest: In the News New Formulations and Indications Newly Approved Drugs Apps of the Month New Generic Approvals Drug Safety Recalls Resolved Drug Shortages New Drug Shortages Drug Information Question $63 Million Won by Teenager from Massachusetts from Johnson & Johnson Samantha Reckis experienced the adverse reaction toxic epidermal necrosis in 2003 after taking Motrin for fever. Samantha, now 16, suffered brain damage, lost 90% of her skin, and went blind from the reaction. The lawsuit alleged that Johnson & Johnson failed to properly warn consumers in the labeling that Motrin could cause life-threatening reactions. A similar case involving Children’s Motrin in 2011 awarded a Pennsylvania girl $10 million dollars after suffering toxic epidermal necrosis. March is National Colorectal Cancer Awareness Month! Colorectal cancer was the second leading cause of cancer-related deaths in 2009. The US Preventative Services Task Force recommend that adults get a colonoscopy every 10 years starting at age 50. Screening helps prevent cancer by identifying and removing precancerous polyps, or by being able to treat colorectal cancer in its early stages. Make sure your family and patients aren’t among the 37% of patients who are not getting screened as recommended! Page 2 Express Scripts Drug Information & Wellness Center Volume 5 Issue 2 New Formulations and Indications Delzicol (mesalamine) delayed release capsule (2/1/13) Indication: mild to moderate ulcerative colitis (UC), or UC in remission Dosing: 800 mg three times daily for active UC, or 1.6 g in divided doses New ly Approved Drugs for UC in remission. MOA: unknown, but may topically block cyclooxygenase and inhibit prosta- Ravicti (glycerol phenylbutyrate) oral liquid by Hyperion Therapeutics, glandin production in the colon. Inc. (2/1/13) New Formulation: delayed release capsule Versacloz (clozapine) oral suspension (2/6/13) Indications: treatment-resistant schizophrenia and reducing suicidal behavior in patients with schizophrenia or schizoaffective disorder. Dosing: target dose of 300-400 mg daily in divided doses. MOA: antagonism of dopamine type 2 and serotonin type 2a receptors New Formulation: oral suspension Vituz (hydrocodone bitartarate and chlorpheniramine maleate) oral solution (2/20/13) Indication: cough and symptoms associated with upper respiratory allergies or a common cold. Dosing: 5 mL (5 mg hydrocodone/4 mg chlorpheniramine) every 4 - 6 hours as needed. Mechanism of Action: Hydrocodone: unknown, but is believed to act directly on the cough center. Chlorpheniramine: H1 receptor antagonist with anticholinergic and sedative activity. New Combination Stivarga (regorafenib) tablets by Bayer HealthCare Pharmaceuticals Inc. (2/25/13) Indication: metastatic colorectal cancer. Dosing: 160 mg daily for the first 21 days of each 28-day cycle. MOA: inhibits kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis, and maintenance of tumor environment. New Indication: locally advanced, unresectable or metastatic gastrointestinal stromal tumor Indication: Urea Cycle Disorders Dosing: 4.5 – 11.2 mL (5 – 12.4 g)/m2 divided among three daily doses Mechanism of Action: Provides an alternate route for excretion of waste nitrogen by conjugating with glutamate, which contains two molecules of nitrogen, via acetylation. It is then excreted renally. Pomalyst (pomalidomide) capsules by Celgene Corporation (2/8/13) Indication: multiple myeloma Dosing: 4 mg daily on days 1-12 of repeated 28-day cycles until disease progression MOA: exerts antineoplastic activity by enhancing T cell- and natural killer cell-mediated immunity and inhibiting proliferation of pro-inflammatory cytokines. Kadcyla (ado-trastuzumab emtansine) for injection by Genetech, Inc. (2/22/13) Indication: HER2-positive metastatic breast cancer Dosing: 3.6 mg/kg as an IV infusion every 3 weeks MOA: binds to the HER2 receptor and is internalized by the cell and degraded to release the cytotoxin DM1, disrupting microtubule networks in the cell and resulting in cell death. Osphena (ospemifene) tablets by Penn Pharmaceutical Services Ltd. (2/26/13) Indication: moderate to severe dyspareunia Dosing: 60 mg daily with food MOA: estrogen agonist/antagonist with tissue selective effects Abilify Maintena (aripirazole) injectable solution by Otsuka America Pharmaceutical, Inc. (2/28/13) Indication: schizophrenia. Dosing: 400 mg IM monthly. Dose range of 160 – 300 mg for poor metabolizers or concomitant CYP450 inhibitors. W NE ! MOA: unknown, but may be through partial agonist activity at D2 and 5HT1A receptors and antagonist activity at 5-HT2A receptors. New Formulation: once monthly extended release injection Apps of the Month The following applications for smartphones has been reviewed and critiqued by students and pharmacists: Name: LactMed Cost: Free Name: Google Translate Cost: Free Content: Provides information on drug level in breast milk, Rating (1-5): effects in infants, and effects on lactation for thousands of medications and herbal supplements. References from the literature are cited for all information provided. Information in this app comes from the National Library of Medicine’s Toxicology Data Network. Content: Never let the language barrier get between you Rating (1-5): and your patients again! Provides the ability to translate text in 65 languages as well as speaking the text in 40 languages. Page 3 Volume 5 Issue 2 Express Scripts Drug Information & Wellness Center 2013 New Drug Shortages Resolved Drug Shortages Aminocaproic Acid Injection by Hospira Inc. (03/08/2013) Products: 250 mg/mL (20 mL vials) Reason: No reason provided Related Information: Shortage per manufacturer due to capacity restraints. Next delivery available in April with full recovery estimated by June 2013. Calcitriol 1 mcg/mL Injection by Abbott Laboratories Related Information: Abbott has supplies available for ordering. Ammonium Chloride Injection by Hospira Inc. (03/08/2013) Products: 5 mEq/mL (20 mL vial) Reason: Manufacturing delay Related Information: Hospira anticipates a release date and full recovery to occur in the second quarter of 2013. Oxsoralen-Ultra (methoxsalen) 10 mg Capsules by Valeant Pharmaceuticals International Related Information: No further supply issues anticipated. Cytarabine Injection by Bedford, APP, and Hospira Inc. Related Information: APP and Hospira report good supply and no further supply issues are anticipated. Beford is working to increase supplies as well. Propofol Injection by Hospira Inc. and APP Related Information: No further supply issues anticipated. Streptomycin for Injection, USP by X-Gen Pharmaceuticals Related Information: X-Gen now has streptomycin injection available. Vasopressin Injection by American Regent/Luitpold, JHP, and APP Related Information: No further supply issues anticipated. 2013 Drug Safety Recalls New Generic Approvals Acetylcysteine Solution, USP by Bedford Reason/Problem: Visible glass particle found in a vial. Generic 1) Betamethasone/ Calcipotriete Ointment Brand Taclonex Ointment Lo/Ovral-28 by Pfizer, Inc. Reason/Problem: Some blister packs may contain an inexact count of inert or active ingredient tablets and the tablets may be out of sequence. 2) Mupirocin Cream Bactroban Cream January 24, 2013 3) Rosiglitazone Tablets Avandia January 25, 2013 Aveeno® Baby Calming Comfort® by Johnson and Johnson Reason/Problem: The lot exceeded bacterial specifications 4) Doxurubicin Injection Doxil February 4, 2013 5) Mafenide Topical Solution Sulfamylon February 12, 2013 Treanda (bendamustine HCl) for Injection by Cephalon Reason/Problem: Presence of particulate matter in vial identified as glass fragments. 6) Buprenorphine/Naloxone Suboxone Sublingual Tablets February 22, 2013 7) Travoprost Opthalmic Solution March 1, 2013 Hair Regrowth Products by Perfect Image Solutions, LLC Reason/Problem: Unapproved new drug products that may present potential health hazards. Vagifresh Ball and Gel by USA Far Ocean Group Reason/Problem: Vagifresh Gel contains benzocaine and Vagifresh Ball contains numerous bacteria. Polymyxin B for Injection, USP and Vecuronium Bromide by Bedford Reason/Problem: Vials may contain visible glass particulates. Excedrin, NoDoz, Bufferin, and Gas-X by Novartis Reason/Problem: Products may contain stray tablets, capsules, or caplets from Novartis products, or contain broken or chipped tablets. Motrin IB Coated Tablets and Caplets by McNeil Reason/Problem: May not dissolve as quickly as intended. Travatan Z Date Approved January 14, 2013 8) Zoledronic Acid Injection Zometa March 4, 2013 9) Desvenalfaxine Extended Pristiq March 4, 2013 Volume 5 Issue 2 Page 4 Drug Information Question Why does the African American patient population experience angiotensin converting enzyme inhibitor (ACEi) induced cough and angioedema at a higher rate relative to other patient populations? The exact mechanism of ACEi induced cough and angioedema is unclear; however, increased levels of bradykinin (bK) has been proposed as a possible cause of the side effects. Bradykinin is a potent vasodilator that causes decreased blood pressure. ACE inhibitors work to decrease blood pressure by inhibiting the breakdown of bradykinin. Gainer et al. investigated the relationship between bK, ethnicity, and ACE inhibitors. Gainer et al. hypothesized that bK sensitivity may play a role in the rate of angioedema seen in African Americans (AA) based on evidence that AA with hypertension have lower levels of urinary kallikrein (an enzyme which cleaves bK from kininogen) than Caucasians (CC). With lower levels of kallikrein, patients would have a decreased ability to break down bK and would be at greater risk of developing an adverse event from the higher bK levels. Gainer tested this hypothesis by measuring a wheal response to two separate intradermal doses of bK in hypertensive (N = 47 AA and 41 CC) and normotensive (N = 36 AA and 33 CC) subjects. The doses, 1 µg and 10 µg, were administered on separate days. Both normotensive and hypertensive AA, at low doses, displayed significantly greater wheal size (p < 0.02 & p < 0.03, respectively) than their CC comparators. High dose wheal size in normotensive AA was significantly higher than in CC (p < 0.03). Higher doses of bK were associated with greater wheal size in all 4 groups (p < 0.001). Furthermore, AA with hypertension have been shown to have higher levels of ACE than CC with hypertension. ACE inhibitors prevent ACE from degrading bK. Gainer et al. proposed that in response to an increase in bK levels seen with ACE inhibitors, AA may have up regulation in bK receptors, thus leading to an increased sensitivity to bK. (1) A second Gainer et al. article builds on the results of the 1996 article and goes a step further to investigate if genetic variations that effect intrinsic levels of ACE, seen in different ethnicities, effect the response to exogenous bK increases. As mentioned prior, bK is a potent endogenous vasodilator. Forearm blood flow (FBF), a validated measure of vasodilator response, was used to determine patient response to exogenous bK. FBF was measured in 14 white and 14 black patients after receiving bK (100, 200, and 400 ng/min), acetylcholine (15, 30, and 60 µg/min), and sodium nitroprusside (0.8, 1.6, and 3.2 µg/min). Each patient received 1 ml/minute for 5 minutes. FBF was measured over the last 2 minutes of each infusion. Patients were unaware of their ACE genotype (insertion/deletion variations). No differences existed between gene loci at baseline between groups. Homozygous ACE deletion polymorphism has been shown to result in increased bK degradation. The results of this study show that normotensive AA patients with homozygous ACE deletion polymorphism, had increased forearm blood flow compared to heterozygous counterparts (p = 0.01). This outcome further supports the hypothesis that exogenous bK may cause an up regulation in bK receptors in patients whom have typically low bK levels, further detailing how ACE inhibitor induced increase of circulating bK could lead to increased response to bK side effects. The outcomes of this study also showed that CC ACE heterozygous insertion/ deletion patients had clinically significant higher response (p < 0.001) to exogenous bK than did AA ACE heterozygous insertion/ deletion patients; this result indicates that response to bK is a race specific anomaly that has not been physiologically identified yet. (2) The cause of increased rate of ACE inhibitor induced cough and angioedema in African American patients is not immediately clear, although it has been proposed that bK levels play a role. Studies have shown a clinically significant difference between AA and CC in endogenous bK levels as well as in their responses to exogenous bK. Therefore, the adverse reactions such as angioedema and dry cough manifested in African American patients on ACE inhibitors may be due to an increased up regulation of bK because of lower endogenous levels compared to CC patients. 1: Gainer JV, Nadeau JH, Ryder D, Brown NJ. Increased sensitivity to bradykinin among African Americans. J Allergy Clin Immunol. 1996 Aug;98(2):283-7. 2. Gainer JV, Stein CM, Neal T, et al. Interactive effect of ethnicity and ACE insertion/deletion polymorphism on vascular reactivity. Hypertension 2001;37 (1): 46-51. Express Scripts Drug Information & Wellness Center Southern Illinois University Edwardsville Monday — Friday 8 a.m. — 4 p.m. (618) 650-5142 [email protected]