
FDA Warns of Potential Risks Associated with Ephedra-Containing Dietary Supplements
In recent years, dietary supplements containing ephedra have been extensively promoted and used as weight loss aids, energy boosters and sports performance enhancers. But mounting evidence suggests that ephedra may be associated with significant health risks. Since the death of Baltimore Orioles pitcher, Steve Bechler, a 23-year-old ephedra user, this popular supplement is once again under scrutiny by the Food and Drug Administration (FDA).
Ephedra is a naturally occurring substance derived from the Chinese herb Ma Huang. Its principle active ingredient, ephedrine, was once a primary treatment for asthma. Its other major ingredient, pseudoephedrine, has been used as a decongestant. More recently, ephedra has been taken as a dietary supplement for its stimulant and appetite suppressant effects.
Evidence Points to Safety Concerns
A growing body of evidence has been accumulating about potentially serious health concerns following the use of ephedra-containing supplements. Studies undertaken by the National Institutes of Health, the RAND Corporation and others have provided evidence that dietary supplements containing ephedra have potentially dangerous effects on the nervous system and heart.
The RAND study, for example, concluded that ephedra is associated with higher risks of numerous adverse effects, including:
Heart palpitations
Nausea and vomiting
Tremor
Insomnia
Psychiatric effects
According to the FDA, the risk of these side effects increases when ephedra-containing dietary supplements are taken with other stimulants, such as caffeine.
The RAND study’s review of 16,000 reports of adverse effects showed other far more serious complications associated with the use of ephedra supplements including two deaths, four heart attacks, nine strokes, one seizure, and five psychiatric cases. The reviewers found no other contributing factors to the adverse effects. However, case studies are a weak form of scientific evidence, and other unmeasured factors may have contributed to the adverse effects. According to the reviewers of the RAND study, the reports may indicate a safety problem, but they do not prove that ephedra actually caused the adverse events.
Additional studies have raised concern about the safety of ephedra. A study published in the February 2003 issue of the Annals of Internal Medicine found that ephedra supplements make up only one percent of all dietary supplement sales, but account for 64 percent of adverse effects associated with dietary supplements.
A case-control study published in a 1993 issue of Neurology concluded that the rate of hemorrhagic (bleeding) strokes among ephedra-users was significantly higher than among nonusers, for people taking doses above 32 milligrams a day. According to the FDA, many ephedra-containing dietary supplement labels recommend that users take up to 100 mg of ephedra daily.
Will The FDA Ban Ephedra?
Under the Dietary Supplement Health and Education Act of 1994, the FDA does not review the safety and effectiveness of dietary supplements before they are marketed. Rather the burden of proof is on the FDA to show that a product already on the market poses an unacceptable risk to the public. To date, the federal government says it has not compiled enough evidence regarding the dangers of ephedra to meet that standard.
The FDA and the Department of Health and Human Services have announced that they will take the following steps to protect Americans from the potentially serious risks associated with dietary supplements containing ephedra.
Continuing to record new evidence on ephedra
Assessing whether dietary supplements containing ephedra present an unreasonable risk of illness or injury, based on currently available evidence
Proposing a new warning label on ephedra products
Requiring manufacturers to back up their claims that ephedra enhances athletic performance
Recommendations
The FDA cautions the public about the use of ephedra, particularly athletes, people engaging in strenuous workouts, and those who are taking caffeine and other stimulants. They also caution against long-term use of ephedra.
Based on the known risks of ephedrine, ephedra should not be taken by a person with:
Cardiovascular disease
Kidney or liver disease
Enlargement of the prostate
Diabetes
Diseases of the nervous system
Glaucoma
Hyperthyroidism
Inflammation of the heart muscle (myocarditis)
Vasculitis
Children under the age of 18 along with pregnant or nursing women should also avoid ephedra.
Ephedra should never be combined with monoamine-oxidase (MAO) inhibitors or Nardil, which are antidepressants.
While the serious adverse effects associated with ephedra appear to be infrequent, the effects can be serious and possibly fatal. You should talk to your doctor if you are currently using ephedra or considering using it.
by Amy Scholten, MPH
Shekelle P, Morton, S., Maglione M, et al. Ephedra and Ephedrine for Weight Loss and Athletic Performance Enhancement: Clinical Efficacy and Side Effects. Evidence Report/Technology Assessment No. 76, Southern California Evidence-based Practice Center, RAND.
M.S. Wetzel, T.J. Kaptchuk, A. Haramati, and D.M. Eisenberg. Complementary and alternative medical therapies: implications for medical education. Ann Intern Med. 2003; 138:191-196
RESOURCES:
Food and Drug Administration
Department of Health and Human Services
SOURCES:
The Natural Pharmacist
Food and Drug Administration website. Available at: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00875.html
Accessed on March 4, 2003
Bruno, A, Nolte KB, Chapin, J. Stroke associated with ephedrine use. Neurology. 1993;43:1313-1316
