Alerts
Orlistat (Xenical and Alli): Ongoing Safety Review
August 28, 2009
The FDA is conducting an ongoing review of safety data concerning liver-related events in patients using orlistat. Orlistat is marketed as Xenical (prescription) and Alli (OTC). Since 1999, 32 reports of serious liver injury were reported to the FDA. Included in those reports were 6 cases of liver failure in patients using orlistat. Jaundice, weakness, and abdominal pain were the most common side effects from the 32 reports. The FDA is also reviewing other suspected liver injury cases submitted by orlistat manufacturers. No association between orlistat and liver injury has been found at this time.
No change in orlistat prescribing practices is recommended at this time. Consumers using orlistat should continue to use product as directed. 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 summary:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm180025.htm - Early Communication:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ucm179166.htm - News Release:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm180057.htm
Updated
August 28, 2009. University of Utah, Drug Information Service.
Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
