Consumer Complaints About Safety of Ephedra Do Not Prove Health Risks, GAO Finds
The 16,000 consumer health complaints reported about Metabolife International ephedra products do not prove that the dietary supplement causes heart attacks and strokes, according to a General Accounting Office report released yesterday, the AP/Las Vegas Sun reports. The report examined 16,000 records of telephone calls to Metabolife from consumers who used the company's ephedra products and complained of health problems; Metabolife submitted the records to the Justice Department last year. According to the report, "there was far too little information to definitively link" reported health problems to ephedra because consumers, not physicians, made the complaints and because Metabolife employees in some cases only recorded one word from the telephone calls, the AP/Sun reports. The 16,000 records examined in the report included 92 complaints of serious side effects -- 18 heart attacks, 26 strokes, 43 seizures and five deaths.
Rep. Dan Burton (R-Ind.), who requested the report, said that the report indicates that the federal government should establish a system to track consumer health complaints related to dietary supplements. In addition, the FDA said that the report does not indicate that ephedra is safe. "Today's report does nothing to change FDA's heightened concern that dietary supplements containing ephedra may present a significant and unreasonable risk of illness and injury," the agency said (Neergaard, AP/Las Vegas Sun, 4/30). HHS Secretary Tommy Thompson on Feb. 28 said that the department would seek new restrictions on ephedra, such as labels to warn consumers about health risks, and that the FDA would collect more information about ephedra to determine whether the agency should ban the dietary supplement (California Healthline, 3/3). Metabolife representatives said the report indicates that ephedra products "are safe and effective when used as directed" (AP/Las Vegas Sun, 4/30).
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