Popular Stimulant Requires Regulation, IU Physician Testifies
INDIANAPOLIS - Ephedra, an over-the-counter herbal drug marketed as
a dietary supplement, can help you lose weight, improve your athletic
prowess and boost your short-term energy level. And for many users, it
can increase your odds of heart attack, stroke and death.
For these reasons, ephedra and other caffeine-based consumer products
should be carefully regulated by the U.S. Food and Drug Administration.
That's the message Douglas P. Zipes, M.D, an Indiana University School
of Medicine cardiologist, delivered to Capitol Hill in testimony before
the House Subcommittee on Oversight and Investigations on July 23.
Dr. Zipes, director of the Krannert Institute of Cardiology and past
president of the American College of Cardiology, recommended to lawmakers
the government take action in four critical areas:
- Recognize that ephedra and ephedrine are drugs and not dietary supplements
- Recognize these products are capable of "provoking harm, including
ventricular fibrillation and sudden death"
- Eliminate over-the-counter use based on "minor proven benefit"
and potential for major harm
- Regulate their use by applying FDA criteria to distribution of ephedra/caffeine
compounds as it done for all other drugs
Herbal products containing ephedra, also known as herbal ephedrine alkaloids,
are marketed in the United States as dietary supplements that claim to
promote weight loss and bolster energy. Ephedrine alkaloids, including
the chemical known as ephedrine, are amphetamine-like compounds that potentially
have powerful stimulant effects on the nervous system and heart. These
alkaloids are found naturally in a number of plants, including the ephedra
species of herb also known by its traditional Chinese medicine name, ma
huang. They also can be manufactured in the laboratory.
"Because of limitations in the current reporting system, it is estimated
that less than 1 percent of the adverse effects caused by dietary supplements
are reported to the FDA," said Dr. Zipes. "If a safety concern
arises, the burden of proof for safety lies not with the manufacturer
but with the FDA to prove that the produce is unsafe. In particular, dietary
supplements containing ephedra and caffeine illustrate the health risks
posed to consumers."
Under the 1994 Dietary Supplement Health and Education Act, herbs can
be labeled with information on their effects on the structure and function
of the body. However, the labels must include disclaimers that state that
the FDA has not reviewed the safety and efficacy of the herb and the herb
should not be used to treat a specific illness.
Under current laws, the FDA cannot require all herbal products be tested
for safety before they become available to consumers.
Dr. Zipes is a clinical cardiologist and scientist specializing in heart rhythm disturbance and is a Distinguished Professor at Indiana University.
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Media Contact: Joe Stuteville
317-274-7722
jstutevi@iupui.edu
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