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FDA launches effort to ban ephedra products: linked to serious adverse events.(News)
The Food and Drug Administration has announced plans to ban the sale of all dietary supplements containing ephedra, marking the first time the agency has moved to ban a dietary supplement. The agency has issued a consumer alert advising the public to immediately stop buying and using products containing ephedra.
FDA Commissioner Dr. Mark B. McClellan and Health and Human Services Secretary Tommy G. Thompson announced the agency's plan to publish a final rule prohibiting the use and sale of dietary supplements containing ephedrine alkaloids. The FDA rule will state that the use of ephedra poses an unreasonable risk of serious illness or injury. The ban becomes effective 60 days following publication of this rule; however, the FDA could not give an exact date when the rule would be published as it is still under review.
The FDA "worked hard to obtain and review all available evidence about the risks and benefits of ephedra, including its pharmacology, studies of ephedra safety and effectiveness, adverse event reports, and reviews by independent experts," Dr. McClellan said in a statement.
Ephedra is contained in a variety of products that claim it can aid weight loss, enhance athletic performance, and increase energy. Aside from some evidence showing limited effectiveness for short-term weight loss, the FDA could not substantiate any other benefits.
Adverse events linked to ephedra include increased blood pressure, heart ailments, strokes, dizziness, psychosis, headache, exfoliative dermatitis, and insomnia, as well as uterine contractions.
As many as 155 deaths have been tied to the dietary supplement, including the high-profile death last year of 23-year-old Baltimore Orioles pitcher Steve Bechler. The National Football League banned the use of the herb by its players, and last year legislatures in California, Illinois, and New York had banned its use.
Several large retailers, including GNC and 7-Eleven stores, had also stopped selling ephedra before the announcement from the FDA.
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