Reactions 1267 - 29 Aug 2009 US FDA reviewing safety of orlistat The US FDA has issued an early communication regarding its ongoing review of safety data for the antiobesity agent orlistat. 1,2 The agency is reviewing adverse event reports of liver injury among patients receiving orlistat – either the prescription product Xenical or the over-the-counter product Alli. Between 1999 and 2008, the FDA received 32 reports of serious liver injury in patients receiving orlistat. 1,2 Of those, hospitalisation was required in 27 cases and 6 case resulted in liver failure. Thirty of the adverse event reports occurred outside the US. The most commonly reported adverse events included jaundice, weakness and stomach pain. The agency is currently reviewing additional data submitted by the drug’s manufacturers on suspected cases of liver injury, and the issue has been discussed by the Center for Drug Evaluation and Research’s Drug Safety Oversight Board. 1,2 To date, no definite association between liver injury and orlistat has been established. Therefore, patients receiving Xenical should continue treatment as prescribed and those using over- the-counter Alli should continue to use the product as directed. However, both groups should consult their healthcare professional if they experience symptoms possibly associated with the use of orlistat and development of liver injury – in particular, weakness or fatigue, fever, jaundice or brown-coloured urine. 1. FDA. Early communication about an ongoing safety review orlistat (marketed as Alli and Xenical). Internet Document : [2 pages], 24 Aug 2009. Available from: URL: http://www.fda.gov. 2. FDA. FDA Issues Early Communication about Ongoing Safety Review of Weight Loss Drug Orlistat. Media Release : 24 Aug 2009. Available from: URL: http://www.fda.com. 801075555 1 Reactions 29 Aug 2009 No. 1267 0114-9954/10/1267-0001/$14.95 © 2010 Adis Data Information BV. All rights reserved

US FDA reviewing safety of orlistat

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Page 1: US FDA reviewing safety of orlistat

Reactions 1267 - 29 Aug 2009

US FDA reviewing safety of orlistatThe US FDA has issued an early communication

regarding its ongoing review of safety data for theantiobesity agent orlistat.1,2 The agency is reviewingadverse event reports of liver injury among patientsreceiving orlistat – either the prescription productXenical or the over-the-counter product Alli.

Between 1999 and 2008, the FDA received 32 reportsof serious liver injury in patients receiving orlistat.1,2 Ofthose, hospitalisation was required in 27 cases and6 case resulted in liver failure. Thirty of the adverse eventreports occurred outside the US. The most commonlyreported adverse events included jaundice, weaknessand stomach pain.

The agency is currently reviewing additional datasubmitted by the drug’s manufacturers on suspectedcases of liver injury, and the issue has been discussed bythe Center for Drug Evaluation and Research’s DrugSafety Oversight Board.1,2 To date, no definiteassociation between liver injury and orlistat has beenestablished. Therefore, patients receiving Xenical shouldcontinue treatment as prescribed and those using over-the-counter Alli should continue to use the product asdirected. However, both groups should consult theirhealthcare professional if they experience symptomspossibly associated with the use of orlistat anddevelopment of liver injury – in particular, weakness orfatigue, fever, jaundice or brown-coloured urine.1. FDA. Early communication about an ongoing safety review orlistat (marketed as

Alli and Xenical). Internet Document : [2 pages], 24 Aug 2009. Available from:URL: http://www.fda.gov.

2. FDA. FDA Issues Early Communication about Ongoing Safety Review ofWeight Loss Drug Orlistat. Media Release : 24 Aug 2009. Available from:URL: http://www.fda.com.

801075555