Agency Has Received Case Reports Of Hepatotoxicity For Orlistat, The Active Ingredient For Xenical And Alli
(Posted by Tom Lamb at DrugInjuryWatch.com)
There was only this brief mention in the Memorandum of Meeting Minutes for the FDA's April 16, 2009 Drug Safety Oversight Board Meeting:
The Drug Safety Oversight Board (DSB) discussed two topics: the product orlistat and the potential risk of hepatotoxicity and alcohol-based skin antiseptics and the risk of a fire in the operating room.
Now, about a month later, we have some additional information about the orlistat - hepatotoxicity part of that DSB April 2009 meeting.
As background, the anti-obesity agent orlistat is the active ingredient in the prescription drug Xenical (Roche) and the over-the-counter drug Alli (GlaxoSmithKline).
Reporter Sue Sutter, in her May 21, 2009 article "US FDA examining reports of liver damage with orlistat", published online by Scrip News (subscription required; free trial available), takes us forward from there:
"Orlistat was discussed in the context of both non-prescription and prescription versions and the potential risk of hepatotoxicity based on several postmarketing reports," the FDA told Scrip.
The agency said it was still reviewing the case reports to determine the extent of orlistat's contribution, if any, to the development of liver damage. The FDA declined to provide the number of postmarketing reports it has received and said any action would depend upon results of its ongoing analysis....
Roche said more than 35 million patients have been exposed to orlistat therapy, and obesity is a high risk factor for hepatic injury. "The available information – postmarketing spontaneous reports, clinical trial data and published literature as well as epidemiology data for drug-induced liver disease – does not suggest that orlistat is causally related to hepatic events."
The current package insert, or label, for Xenical (accessed 5/22/09) mentions rare reports of hepatic, or liver, injury.
Previously, the anti-obesity agent orlistat had been under scrutiny at the FDA for concerns about rectal bleeding. See: Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between April - June 2008
If you are aware of any cases of drug-induced hepatitis, liver injury, or liver failure involving the use of Xenical or Alli, please let us know by submitting a Comment, below, or you can send me a private email.
P.S. On August 24, 2009 the FDA issued its "Early Communication about an Ongoing Safety Review Orlistat (marketed as Alli and Xenical)". (8/25/09)