FDA evidence too weak to restrict ephedra, report says
August 4, 1999
Web posted at: 12:38 p.m. EDT (1638 GMT)
(CNN) -- A new government report released Wednesday says the U.S. Food and Drug Administration (FDA) does not have the evidence needed to put restrictions on ephedra, a popular weight loss herb the federal agency considers dangerous.
Ephedra, also called ma huang, epitonin and sida cordifolia, contains stimulants known chemically as ephedrine. It has been promoted as a natural version of the once-popular diet drug combination fen-phen.
The FDA had proposed limits on ephedrine levels in supplements and warning labels recommending ephedra products be taken for no more than seven days.
The General Accounting Office, an investigative arm of Congress, was asked to look into the FDA's proposed restrictions after the dietary supplements industry approached Congress about the FDA's conclusions.
Since 1994, the FDA has had more than 800 reports of side effects from ephedrine, including heart palpitations, psychosis, heart attacks and strokes. But the GAO said the FDA needed to provide better evidence to support the proposed restrictions, according to a memo prepared by the House Science Committee staff.
"FDA needs to provide stronger evidence on the relationship
between the intake of dietary supplements containing ephedrine
alkaloids and the occurrence of adverse reactions," the GAO
The FDA relied heavily on so-called Adverse Events Reports without providing its usual follow-up investigation, the GAO said.
The GAO report is considered a victory for dietary supplements. Metabolife International, one of the largest distributors of ephedra in the United States, says many of the people in the FDA reports who died may have been taking the supplement, but it didn't kill them.
"There are reports in there where someone was shot and killed in a grocery story, and they happened to be taking an ephedra dietary supplement," said Metabolife's Dr. Randy Smith.
Still, University of Arkansas pharmacologist Bill Gurley said he is worried about people who take ephedra products for many weeks or who take more than the recommended dosage on the label.
"You have to realize that these things are potent cardiac stimulants, and when you are exercising and lifting heavy weights, you are already taxing your cardiovascular system, and all this does is make it work harder," said Gurley.
Gurley has analyzed approximately 20 ephedra products and found great variability in the amount of active ingredient, not only between products but often within the same brand.
"If a conventional pharmaceutical company had this kind of quality control, the FDA would shut them down in a heartbeat," Gurley said.
A 1994 federal law essentially removed dietary supplements, like herbs, from FDA control. As a result, supplements aren't subjected to the same strict clinical testing standards as prescription and most over-the-counter drugs.
Though it won't appear on the label, the FDA continues to recommend that those who are pregnant or have high blood pressure, heart conditions or neurological disorders avoid ephedra-based products.
Medical Correspondent Linda Ciampa and Reuters contributed to this report.
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