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Drug Safety Podcasts for Healthcare Professionals: Completed safety review of Xenical/Alli (orlistat) and severe liver injury

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Welcome, my name is Mary Kremzner, a pharmacist in the Division of Drug Information. Today, I am updating you on the revised label for Xenical to include new safety information about cases of severe liver injury that have been reported rarely with the use of this medication. The agency is also adding a new warning about rare reports of severe liver injury to the OTC Drug Facts label for Alli and is working with the manufacturer to ensure that consumers can understand this new warning.

Xenical and Alli are medications used for weight-loss that contain different strengths of the same active ingredient, orlistat. Xenical contains 120mg of orlistat, is available by prescription and Alli, containing 60mg of orlistat is sold over-the-counter without a prescription.

This new safety information, originally announced in August 2009, is based on FDA's completed review that identified 13 total reports of severe liver injury with orlistat; 12 foreign reports with Xenical and 1 U.S. report with Alli.

The decision to include information about severe liver injury in the drug label for Xenical and Alli is based on FDA's comprehensive review of all available data including the pre-clinical, clinical trial, postmarketing, and drug utilization on severe liver injury associated with Xenical through August 7, 2009 and a review of postmarket data on Alli through October 1, 2008. There were no signals of significant liver injury in either the pre-clinical studies or clinical trials data.

FDA identified 12 postmarketing cases of severe liver injury reported with the use of Xenical and one case reported with the use of Alli. In some of these cases, other factors or drugs may have contributed to the development of severe liver injury.

Of the 13 cases:

  • Twelve were foreign reports of severe liver injury with Xenical.
  • One was a U.S. report of severe liver injury with Alli.
  • Two patients died from liver failure.
  • Three patients required liver transplantation.

The following factors make confirming a cause-and-effect relationship between orlistat and severe liver injury difficult:

  1. One U.S. case with Alli and 12 foreign cases with Xenical reported between April 1999 and August 2009 out of an estimated 40 million people worldwide who have used Xenical or Alli.
  2. Some patients in the reported cases also used other drugs or had other conditions that may have contributed to the development of severe liver injury.
  3. Severe liver injury can occur in people not taking drugs and without a distinct cause.

At this time, a cause and effect relationship of severe liver injury with orlistat use has not been established. Because of the seriousness of severe liver injury, FDA has added information about reported cases of severe liver injury to the label of Xenical and Alli to educate the public about the signs and symptoms of liver injury and the need to see a healthcare professional promptly should they occur.

Healthcare Professionals should:

  1. Be aware that postmarketing cases of severe liver injury with hepatocellular necrosis or acute hepatic failure have been reported rarely in people using Xenical and Alli. Some of these cases resulted in liver transplant or death.
  2. Weigh the benefits of weight-loss with Xenical and Alli against the potential risks when determining if these medications are appropriate for patients.
  3. Instruct patients to report any symptoms of hepatic dysfunction such as anorexia, pruritus, jaundice, dark urine, light colored stools, or right upper quadrant pain when using these medications.
  4. If liver injury is suspected, orlistat and other suspect medications should be discontinued immediately and liver function tests and ALT and AST levels obtained.
  5. Report any adverse events with Xenical or Alli to FDA's MedWatch program at www.fda.gov/medwatch .

Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. If you have questions about this safety communication, you can reach the Division of Drug Information at the following email address: druginfo@fda.hhs.gov.



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