The FDA is slapping new liver-injury warnings on the weight-loss drugs Xenical and Alli. The decision comes after a safety review at the agency, prompted by reports of liver problems among patients using the drugs, including two deaths and three liver transplants.
The agency emphasized that the reports were rare: The FDA got 12 reports of liver injury associated with Xenical from April 1999 to August 2009, and one during that time period associated with Alli. Worldwide, some 40 million people have used one of the drugs. Xenical is a prescription strength form of orlistat, marketed by Roche, while GlaxoSmithKline (NYSE: GSK) markets the over-the-counter strength version Alli.
Plus, FDA hasn't found a causal link. "[A] cause-and-effect relationship of severe liver injury with orlistat use has not been established," the agency says in a statement.
Still, the agency thought it needed to get the word out. "We are telling consumers and health-care providers to be vigilant should [patients] develop symptoms suggestive of liver impairment," FDA spokeswoman Elaine Gansz Bobo tells HealthDay. "We were unable to identify any particular group that may be at increased risk."