FDA Drug Safety Communication

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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.

View the full FDA Drug Safety Communication on FDA.gov