Liver injuries found in patients on orlistat

Cases of severe liver injury with hepatocellular necrosis or acute hepatic failure have been reported in patients taking the weight-loss medication orlistat, the FDA recently announced.

Warnings will be added to the labeling for Xenical (the 120-mg prescription form of orlistat) and Alli (60 mg, available over the counter). The injuries have been reported only rarely (12 foreign reports with Xenical and 1 U.S. report with Alli) and a cause-and-effect relationship has not been established, according to an FDA news release. However, because of the seriousness of severe liver injury, the FDA added information to the labels to educate the public.

Prescribing physicians should weigh the benefits of weight loss against the potential risks when determining if these medications are appropriate for patients and instruct patients to report any symptoms of hepatic dysfunction (anorexia, pruritus, jaundice, dark urine, light colored stools, or right upper quadrant pain) when using these medications. If liver injury is suspected, orlistat and other suspect medications should be discontinued immediately and liver function tests and ALT and AST levels obtained. Any adverse events associated with the medications should be reported to FDA's MedWatch program.