Public Citizen petitioned the U.S. Food and Drug Administration to remove from the market the prescription version of Xenical (orlistat, made by Roche Pharmaceuticals) because the obesity treatment has been known to cause a significant increase in aberrant crypt foci (ACF), which are widely believed to be a precursor to colon cancer.
Last week, the FDA sent an “approvable” letter concerning the over-the-counter (OTC) version of orlistat to GlaxoSmithKline, which has applied to market this version. Despite safety concerns, if GlaxoSmithKline meets the conditions set by the FDA – conditions that have not been made public – this would make the drug eligible for final approval for OTC sales.
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