FDA NEWS RELEASE For Immediate Release: Aug. 24, 2009
Media Inquiries: Siobhan DeLancey, 301-796-4668, siobhan.delancey@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA
FDA Issues Early Communication about Ongoing Safety Review of Weight Loss Drug Orlistat Review includes both prescription drug Xenical and OTC drug Alli
The U.S. Food and Drug Administration announced today that it 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.
Between 1999 and 2008, the FDA received 32 reports of serious liver injury in patients taking orlistat. Of those cases, 27 reported hospitalization and six resulted in liver failure. Thirty of the adverse events occurred outside the United States. The most commonly reported adverse events included yellowing of the skin or whites of the eyes (jaundice), weakness, and stomach pain.
The FDA is reviewing additional data submitted by orlistat manufacturers on suspected cases of liver injury, and the issue has been discussed at the FDA’s Center for Drug Evaluation and Research Drug Safety Oversight Board.
