FDA Releases Early Communication About Ongoing Safety Review Of Xenical

The FDA is reviewing adverse event reports of liver injury in patients taking the weight loss drug orlistat, marketed as the prescription drug, Xenical and the over-the-counter medication, Alli.

Reportedly, FDA has received 32 reports of serious liver injury in patients taking orlistat between 1999 and 2008. The most commonly reported adverse events included yellowing of the skin or whites of the eyes (jaundice), weakness, and stomach pain.

FDA is reviewing additional data submitted by orlistat manufacturers on suspected cases of liver injury, and the issue has been discussed at its Center for Drug Evaluation and Research Drug Safety Oversight Board.

FDA’s analysis of these data is ongoing, and no definite association between liver injury and orlistat has been established at this time. The agency has advised the consumers taking Xenical to continue to it as prescribed, and those using over-the-counter, Alli can continue to use the product as directed.

Steven Osborne, executive director of the Board of FDA, said: “The issues here are complex, but FDA has benefited from the input of the Board, including comments from representatives from three FDA Centers and several other Agencies in the Department of Health and Human Services.”