Pubdate: Wed, 04 Aug 1999 Source: Reuters Copyright: 1999 Reuters Limited. Author: Lisa Richwine Wednesday August 4 12:10 AM ET FDA CAN'T JUSTIFY EPHEDRINE LIMITS, REPORT SAYS WASHINGTON (Reuters) - The Food and Drug Administration does not have enough scientific evidence to support limits on ephedrine, a common weight-loss substance that the FDA considers dangerous, a congressional report to be released Wednesday said. The FDA has warned consumers that dietary supplements containing ephedrine, plant-derived compound that is often promoted as a natural version of the once-popular diet drug combination ``fen-phen,'' can be dangerous because of its potentially powerful stimulant effects. The agency also has proposed limits on ephedrine levels in dietary supplements coupled with warnings against consuming ephedrine-containing products for more than seven days. Some members of Congress asked the General Accounting Office, the investigative arm of Congress, to investigate the FDA's ephedrine proposal after the dietary supplements industry questioned the FDA's conclusions. The GAO concluded that the FDA needed to provide stronger evidence about ephedrine's side effects to support its 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 said. Ephedrine, also known as Ma Huang, is used in dietary supplements promoting weight loss and body building. ''Fen-phen'' was a popular diet drug combination until manufacturers recalled its components in 1997 due to safety concerns. The FDA proposed ephedrine restrictions after receiving more than 800 reports of harmful effects to people taking supplements containing the substance. Reactions included heart problems that could put patients at risk for heart attacks, strokes and death. But the GAO said those reports by themselves are unreliable because they do not prove that the substance caused the reaction and also could include reactions as minor as headaches. In the case of ephedrine, FDA relied heavily on the so-called Adverse Events Reports without providing its usual follow-up investigation, the GAO said. - --- MAP posted-by: Derek Rea