NEJM Article Blasts Ephedra; Industry Responds

November 8, 2000

4 Min Read
NEJM Article Blasts Ephedra; Industry Responds

SAN FRANCISCO--Researchers reviewing adverse event reports reported to the Food and Drug Administration (FDA) concluded that dietary supplements that contain ephedra alkaloids pose a serious health risk to some users. The report was released in early November, more than a month before the final version will be published in the New England Journal of Medicine (Dec. 21 issue), because of the "potential public health implication."

Researchers at the University of California and the California Poison Control System, both based here, reviewed 140 adverse event reports (AERs) related to the use of dietary supplements containing ephedra alkaloids that were submitted to the FDA between June 1, 1997, and March 31, 1999. (The study does not mention that 2/3 of the AERs were self-reported by consumers and 1/3 submitted by medical practitioners.) Christine Haller, M.D., led the research team, which found that 31 percent of the cases were "definitely" or "probably" related to the ephedra supplements and an additional 31 percent were "possibly" related. Of that 62 percent, cardiovascular (hypertension, tachycardia) and central nervous system problems were most common.

They conclude that "the risks of taking ephedra alkaloids as a dietary supplement ... are difficult to justify because the alkaloids have no demonstrated benefit." The study also noted that there is a need for devising appropriate dosing guidelines and warnings, and drew a parallel between the effects of phenylpropanolamine (PPA) with caffeine (a combination banned in 1983) and ephedra and caffeine. Interestingly, the Dec. 21 issue of NEJM will also contain a report on PPA and stroke (also given early public release), which has led FDA to issue a public health advisory about the long-marketed synthetic drug and moved many companies to recall products.

Industry members questioned the timing of the study, its play in the media and some statements that appear inaccurate. "This review has blatant errors of fact," said Michael McGuffin, president of the American Herbal Products Association (AHPA). For example, one patient case detailed in the study showed that the woman's urine sample tested positive for amphetamine; the researchers concluded that she must have taken ephedra because amphetamine is a metabolite of ephedra. "That is erroneous," he said. "This woman was probably taking an amphetamine."

The play in the news struck some industry members as curious, as most information has been reported previously by FDA in the Federal Register. "This is basically the same thing, with minor editorial changes put into a journal article format," said John Hathcock, vice president of nutrition and regulatory sciences at the Council for Responsible Nutrition (CRN). Also, neither the NEJM report nor the media coverage has taken into consideration the benefits and safety of ephedra reported in an large, long-term clinical study conducted at Harvard and Columbia University and released Nov. 1 at the National Association for the Study of Obesity. That study is scheduled to be published in the Jan. 2001 Obesity Research.

Finally, there are notes the NEJM study about 10 of the AERs being in persons under 18 and in a low range of intake (determined to be 8 mg to 36 mg/day of ephedra alkaloids). Since 1994 and as recently as just a month ago, industry associations and companies proposed warning labels detailing users should be over 18 and with a dosage max of 25 mg/dose and 100 mg/day ephedra alkaloids. The industry proposal and currently used labels also advise consumers not to use the products if they have a heart condition.

"We have a cautionary label statement on ephedra products that say don't use this if you have hypertension or heart disease," McGuffin said. "If consumers don't know, they should go find out. They need to read [the warnings], believe it and act like it's true."

Cautionary statements on labels have been one step by the industry to responsibly market dietary supplements. "There's no use in defending that ephedra doesn't have side effects, because it does," said Roy Upton, executive director of the American Herbal Pharmacopoeia (AHP). He added that consumers should have access to the products as long as they are warned of potential side effects so they can measure the risks vs. benefits of a product. "Consumers should decide where ephedra lies on the spectrum of weight loss therapies," he said, particularly when faced with the consequences of obesity and other weight loss therapies.

To access a copy of the NEJM study, visit www.nejm.com. To learn more about ephedra, visit www.ahpa.org or www.EphedraFacts.com.

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