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Thirty of the 32 reports occurred outside the United States. Thirty-two reports of serious liver injury, including 6 cases of liver failure, were reported via the FDA’s Adverse Event Reporting System between 1999 and October 2008. • In the United Kingdom The Medicines and Healthcare products Regulatory Agency (MHRA) received 1,295 reports of suspected adverse drug reactions (ADRs) associated with orlistat since it was licenced in 1998. Of these, 137 were suspected hepatic ADRs (including 2 cases with a fatal outcome) linked to orlistat. A single case of abnormal liver function tests has been reported for Alli™. • Local reports received, In Singapore, orlistat has been approved for use as a Prescription-only item since 10 June 1999. 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