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FDA Delay Ephedra Decision; Issues PC-SPES Warning

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By: Sean Moloughney

Editor, Nutraceuticals World

FDA Delay Ephedra Decision; Issues PC-SPES Warning
FDA is reassessing possible restrictions on ephedra-containing dietary supplements. The administration has reportedly received more than 140 reports of adverse events over the last three years that may be related to the supplements, which contain ephedrine alkaloids from the ephedra or ma huang plant. The industry contends that the reactions, which ranged from minor to fatal, were not related to consumption of products containing ephedrine. The FDA decided to withdraw the proposed restrictions after a report by the General Accounting Office (GAO) concluded that additional evidence was needed before reaching a decision.
In related news, FDA recently issued a warning urging consumers to stop using two products sold as herbal supplements that actually contain powerful prescription drugs. The products—PC SPES and SPES—were manufactured by BotanicLab, Brea, CA, and were recalled after testing by the California Health Department un­covered the contamination. PC SPES capsules, containing a light brown powder marketed for “prostate health,” contain warfarin, a powerful blood thinner often sold under the brand name Coumadin. SPES, capsules containing a brown powder marketed as an immune enhancer, contain alprazolam, an anti-anxiety drug often sold under the brand name Xanax.

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