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Review of Ephedra Adverse Events Scheduled for Publication

November 6, 2000: The New England Journal of Medicine has released the results of an independent review of 140 adverse event reports (AERs) possibly related to ephedra dietary supplements. The report, scheduled for publication in the December 21 issue of NEJM, was posted online in advance of its scheduled publication date because of its "potential public health implications" (www.nejm.com/content/haller/1.asp)

The AERs examined by the authors of the review were filed with the FDA between June 1, 1997 and March 31, 1999. Based on their review, the study authors concluded that "…dietary supplements that contain ephedra alkaloids may pose a health risk to some persons" and that their findings "indicate the need for a better understanding of individual susceptibility to the adverse effects of such dietary supplements." They reported that 69 percent of the AERs were unrelated or only possibly related to the use of ephedra-containing products. For people who did experience side effects, the authors propose that variations in individual sensitivity to ephedrine alkaloids, concomitant use of caffeine, pre-existing medical conditions, or manufacturing inconsistencies may have been a factor in the adverse events. Recognizing this need years ago, the dietary supplement industry voluntarily adopted labeling intended to warn specific populations of consumers to avoid the ephedra-containing products, or to consult their physicians first. The label warning recommended by the American Herbal Products Association (AHPA) reads:

Not intended for use by anyone under the age of 18. Do not use this product if you are pregnant or nursing. Consult a health care professional before using this product if you have heart disease, thyroid disease, diabetes, high blood pressure, psychiatric condition, difficulty in urinating, prostate enlargement, or seizure disorder, if you are using a monoamine oxidase inhibitor (MAOI) or any other prescription drug, or you are using an over-the-counter drug containing ephedrine, pseudoephedrine or phenylpropanolamine (ingredients found in certain allergy, asthma, cough/cold and weight control products).

Based on another recommendation from AHPA, many manufacturers also have adopted labeling that recommends limiting intake of ephedrine alkaloids to 25mg per serving, with daily intake not to exceed 100mg. In addition, these labels indicate the quantity of ephedrine alkaloids per serving. On October 26, 2000, four industry trade associations petitioned FDA to adopt these requirements as the federal standard so that all manufacturers would be compelled to label their products this way. HRF supports the adoption of the requirements, a step that would help educate consumers about the appropriate use of ephedra and prevent overdose, misuse, and abuse of ephedra products.

Pseudoephedrine (an ephedra-derived alkaloid) is an active ingredient of FDA-approved over-the-counter cold medications such as Sudafed®. Ironically, FDA nonprescription drugs chief Dr. Charles Ganley has suggested that consumers substitute products like Sudafed for over-the-counter cold products containing phenylpropanolamine (PPA), which were recently pulled from the market by FDA.

Haller CA, Benowitz NL. Adverse cardiovascular and central nervous system event associated with dietary supplements containing ephedra alkaloids. New England Journal of Medicine; scheduled for publication December 21, 2000

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