FDA evaluates orlistat

FDA is evaluating "rare reports" of hepatitis and liver-related laboratory abnormalities in people taking orlistat - the active ingredient, at 60 mg, in GlaxoSmithKline's OTC weight-loss drug alli. "Because of a lack of information in the reports, at this time, it is not possible to know the degree to which orlistat is responsible for the reported liver problems," an FDA spokeswoman said in an e-mail June 4. The agency is working with GSK to obtain post-marketing safety adverse events associated with orlistat, she added. This evaluation of orlistat, which is also the active ingredient, at 120 mg, in Roche's prescription Rx diet drug Xenical, comes as FDA continues investigating whether adverse event reports of rectal bleeding signal a potential serious risk identified with the ingredient (1"The Tan Sheet" Feb. 9, 2009, p. 8)