FDA Date: 5/26/10
Xenical (orlistat) FDA Drug Safety Communication
Completed Safety Review of Xenical/Alli (Orlistat) and Severe Liver Injury
FDA has approved a revised label for the prescription drug Xenical and an addition to the OTC Drug Facts label for Alli to include a new warning about rare reports of severe liver injury with the use of orlistat. At this time, a cause and effect relationship of severe liver injury with orlistat use has not been established.
FDA advises the following:
- Be aware that postmarketing cases of severe liver injury with hepatocellular necrosis or acute hepatic failure have been reported rarely; some of these cases resulted in liver transplant or death.
- Weigh the benefits of weight-loss with Xenical and Alli against the potential risks when determining if these medications are appropriate for patients.
- 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.