Similar to Over-the-Counter Products, There is No Association Between Reported Adverse Events and Ephedra When Consumed as Directed
A seven-member panel of experts completing the most comprehensive multidisciplinary review of Ephedra concluded today that, as with over-the-counter products that contain ephedrine or pseudoephedrine, there is no association between serious adverse events and Ephedra when consumed as directed. Additionally, based on studies of Ephedra and caffeine, the panel viewed the current data as supporting the usefulness of Ephedra in combating one of the most serious public health problems in the U.S, weight management.
“Available information does not demonstrate an association between the use of dietary supplements containing ephedrine alkaloids and serious adverse events when used according to the American Herbal Products Association (AHPA) trade recommendation for Ephedra products,” said Dr. Stephen E. Kimmel, panel chairman. “This recommendation includes a serving limit of not more than 25 mg of total ephedrine alkaloids, a limit on daily consumption of not more than 100 mg of total ephedrine alkaloids, and appropriate warnings consistent with other available over-the-counter ephedrine alkaloid products.”
Conservative estimates show no greater risk than the risk in the general population. The number of reported events are consistent with what would occur in the general population without the consumption of Ephedra.
In 1997, the U.S. Food and Drug Administration (FDA) proposed an outright ban on the marketing of Ephedra for use in weight management and severe restrictions on serving amounts based primarily on over 800 reports of alleged adverse events the agency had received, but never reviewed over a four year period. As a result of overwhelming criticism from consumers, industry, Congress and a General Accounting Office report establishing that FDA’s proposal had no valid scientific basis, FDA withdrew the most controversial portions of its proposal on April 3, 2000.
Recognizing the confusion and questions that FDA’s more recent release of additional adverse events has caused, the expert panel also recommended that NIH, HHS and industry work together to consider additional research to establish a more comprehensive database, and, as is usual practice, that an independent multidisciplinary panel be formed to review all deaths reported to FDA, even though no association between existing reports and Ephedra was found.
The panel’s findings will be presented at an August 8 Public Health Service meeting convened by the Department of Health and Human Services. Members of the panel were selected because of their scientific and medical experience and broad depth of knowledge in different disciplines, including toxicology, neurology, pathology, and epidemiology, and several members have worked as consultants or as senior management for the FDA.
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