FDA Approves Dangerous Fat-Blocker for OTC Market
April 25 2006
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GlaxoSmithKline has received conditional approval from the FDA to sell the weight-loss drug Xenical over-the-counter. It would be sold under the brand name Alli.
The pill blocks fat from being absorbed by the body. If it wins final approval, it will be the only FDA-approved weight-loss drug available without a prescription.
However, the drug can cause excess gas and oily discharge, and can lead to hepatitis, gallstones and kidney stones. Recent studies have also linked the drug to precancerous colon lesions and a heightened risk of breast cancer, prompting consumer groups such as Public Citizen to petition the FDA to reject GlaxoSmithKline's request for over-the-counter sales and pull Xenical from the U.S. market.