Alerts
Orlistat (Xenical and Alli) and Severe Liver Injury - UPDATE
May 26, 2010
FDA completed a review of safety data concerning liver-related events in patients using orlistat. Orlistat is marketed as Xenical (prescription) and Alli (OTC). During the initial review by the FDA in 2009, 32 reports of serious liver injury were noted. The final FDA review indicates there were 13 cases of severe liver injury, including 2 deaths due to liver failure and 3 patients requiring liver transplantation.
FDA informed health care providers about a change to the labeling for prescription orlistat (Xenical) and over-the-counter orlistat (Alli) to include information about severe liver injury. Consumers using orlistat should continue to use the product as directed. If itching, yellow eyes, dark urine, light colored stools, or loss of appetite develop consumers should stop taking orlistat and contact their health care provider immediately. Continue to report any side effects related to the use of orlistat to the MedWatch Adverse Event Reporting program. More information on this topic is available through the following links.
- FDA MedWatch Safety Communication:
- May 2010
http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ucm213038.htm - August 2009:
http://www.fda.gov/Safety/MedWatch/ SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm180025.htm - FDA Consumer Update (5/2010):
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm213401.htm - Early Communication (8/2009):
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ucm179166.htm - News Release (8/2009):
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm180057.htm
Updated
May 26, 2010; August 28, 2009; University of Utah, Drug Information Service. Copyright 2010, Drug Information Service, University of Utah, Salt Lake City, UT.
