What evidence was collected to determine the safety and effectiveness of ephedra products?
The FDA reviewed information about ephedra’s pharmacology, studies of its safety and effectiveness, newly available adverse event reports, and the RAND Corporation report—a review of the published scientific literature on ephedra efficacy and safety, sponsored by NCCAM and the National Institutes of Health’s Office of Dietary Supplements. In addition, the FDA considered additional recent studies confirming that ephedra use raises blood pressure and otherwise stresses the circulatory system.
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