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Mariann Garner-Wizard
Heather S Oliff, PhD
Shari Henson
Brenda Milot, ELS
Densie Webb, PhD
Executive Editor – Mark Blumenthal Consulting Editors - Steven Foster, Roberta Lee, MD, Allison Turner, MS
Managing Editor – Lori Glenn
Funding/Administration – Wayne Silverman, PhD
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FILE: ƒEphedra (Ephedra sinica)
ƒAdverse Effects of Herbs
ƒHerb Safety
HC 030342-260
Date: July 15, 2004
RE: Case Reports of Ephedra-related Cardiomyopathy
Naik SD, Freudenberger RS. Ephedra-associated cardiomyopathy. The Annals of
Pharmacotherapy 2004;38(3):400-403.
The controversial but popular Chinese herb ephedra (Ephedra sinica) was banned for sales
in dietary supplements in the United States by the Food and Drug Administration (FDA) in
February, 2004. The ban went into effect on April 12, 2004. One of the reasons for the ban
was the mounting concern among health professionals, regulators, journalists, and others
that the herb could produce serious adverse effects even when taken at doses considered
reasonable according to product label guidelines.
Ephedra was in many over-the-counter dietary supplements that promoted weight loss,
enhanced athletic performance, and increased energy before it was removed from the U.S.
market. The stimulant alkaloid ephedrine and related alkaloids in ephedra have been the
focus of most of the attention surrounding the herb's controversy. Ephedrine can increase
heart rate and blood pressure by increasing the release of the neurotransmitter
norepinephrine and by acting on adrenergic receptors (important for heart function). The
effects of ephedra and its ephedrine content in combination with other stimulants may
magnify the effects on heart rate and blood pressure. This paper describes two case reports
of patients who reported taking ephedra and were hospitalized with signs, symptoms, and
evidence of heart failure.
In one case report a 19-year-old man was presented to the emergency room with symptoms
of heart failure. His only prior medical problem was a diagnosis of anemia (low red blood
cell count) 6 months prior to admission. He reported drinking 4-6 cans of beer every other
day, smoking 4 cigarettes per week, and using marijuana twice weekly. At different times
over the prior 2 years the patient had taken Stacker III (produced by NVE Pharmaceuticals
and promoted to increase metabolism and as a weight-loss aid; it reportedly contained
ephedra extract, kola nut extract [Cola nitida], white willow bark [Salix alba], grapefruit
extract [Citrus x paradise], and chitosan [a form of fiber chemically processed from
crustacean shells]), Riboforce (manufactured by Experimental & Applied Sciences; a
body-building aid containing creatine, ribose, and taurine), Ripped Fuel (made by
TwinLabs and promoted for increased energy for body builders; it contains ephedra
extract, guarana extract [Paullinia cupana], caffeine, L-carnitine, and chromium), and IGF
(tissue-growth promoter containing insulin-like growth factor-1). The doses and frequency
of use for each supplement are unknown, or at least were not reported. A comprehensive
serum drug evaluation detected tetrahydracannabinol (one of the primary active
components of marijuana), but not phencyclidine (PCP), benzodiazepines, opiates,
barbiturates, cocaine, or amphetamines. The patient was diagnosed and treated for
congestive heart failure. Upon discharge he was told not to use dietary supplements, but it
is unknown whether he did. Five weeks after discharge the patient returned to the hospital
with exacerbation of heart failure and died within 4 days.
In the other case report a 21-year-old man was presented to the emergency room with
recurrent chest pain and symptoms of heart failure. One week prior to admission he had
symptoms of an upper respiratory tract infection which he did not treat. He had no other
significant medical history. He had smoked a half to one pack of cigarettes a day for 5
years. He denied using alcohol or intravenous drugs. Prior to admission he used TheraFlu
(over-the-counter cold preparation containing pseudoephedrine) and Stacker III for
bodybuilding. The doses and frequency are unknown. He was treated for congestive heart
failure and upper respiratory tract infection. He was discharged with heart medication and
told not to use dietary supplements containing ephedra. He has returned to normal
activities and remains on medication for congestive heart failure.
The authors used the Naranjo probability scale (a popular method for estimating the
probability of adverse drug reactions) to conclude that there was a possible relationship
between ephedra use and cardiomyopathy (disease of the heart muscle). The authors
believe that the alkaloids in ephedra probably produced myocarditis (inflammation of heart
muscle) in these patients via its potent effects on coronary artery constriction. The authors
write that it has been well documented that ephedra causes a range of cardiovascular
toxicities. According to this paper, the FDA has received more than 1,000 reports of
adverse events, including death, associated with ephedra use.
The authors suggest that physicians and pharmacists should advise patients to carefully
read the content of all dietary supplements and educate themselves on the serious adverse
events that may occur with some products. While this is generally sound, responsible
advice, one of the unfortunate results of the recent ban on ephedra and the ensuing negative
publicity is that many relatively safe herbal supplements are being unfairly given a
negative public perception because of the safety problems associated with ephedra.
—Heather S. Oliff, Ph.D.
Enclosure: Referenced article reprinted with permission from The Annals of Pharmacotherapy.
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