Adverse Event Reports Do Not Negate The Science Supporting Safety And Efficacy Of Ephedra
An “Adverse Event Report” (AER) is a report made to FDA by a consumer or health care professional. These reports contain information of widely varying degrees of quality concerning adverse events that may be related to the ingestion of a product. While widely reported as a basis for concern, FDA itself admits that these reports are subjective, do not represent scientific data, cannot be used as a basis for scientific regulation, and ordinarily cannot be used to determine if the adverse event was caused by the product in question.
FDA’s longstanding practice is to use AERs as a signal to consult the available data on a product to determine if the reported events are consistent with the data. Without such consultation, an AER has no scientific significance. Industry’s principal objection to FDA’s statements and ensuing public debate is that it has been based entirely on the scientifically invalid AERs and not on scientific data.
A relatively small number of ephedra AERs have been reported when one considers how widely consumed the product is in the United States. (See industry survey) In spite of the proportionally small number of reports, the EEC has been a strong advocate for the U.S. Department of Health and Human Services, the National Institutes of Health and its Office of Dietary Supplements to study all the available scientific data on Ephedra in order to evaluate whether the AERs collected by FDA provide any cause for concern.
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