The European Medicines Agency has announced that it has started a review of the 
safety of orlistat for liver problems. From May 2007 to January 2011 there were a total of 9 reports of severe liver injury with orlistat 60mg out of usage in 11 million patients. The EMA noted that other possible explanations for liver injury were present and some cases provided insufficient information to allow assessment. European Medicines Agency – News and press release archive – European Medicines Agency starts review of orlistat-containing medicines. In 2010, the US Food and Drug Administration also looked at orlistat safety and changed the label although it found only 13 cases of severe liver injury out of 40 million users and whose liver problems may have had other causes.Postmarket Drug Safety Information for Patients and Providers > Questions and Answers: Orlistat and Severe Liver Injury
