FDA Alerts Public To Ongoing Safety Review Of Orlistat In GSK, Roche Drugs
This article was originally published in The Tan Sheet
Executive Summary
FDA's announcement it is investigating a possible risk of liver injury related to orlistat - the active ingredient in Roche Pharmaceuticals' prescription weight-loss drug Xenical and GlaxoSmithKline's OTC alli - could threaten short-term sales
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GSK adds alli warning
Following an FDA safety review of the weight-loss drug orlistat, GlaxoSmithKline adds to alli packaging a warning about "rare reports of liver injury in people taking orlistat," and cautions consumers to "stop use and ask a doctor if you develop itching, yellow eyes or skin, dark urine or loss of appetite," the Parsippany, N.J.-based firm announced May 26. FDA also approved a revised label for Xenical, the prescription-strength version of alli marketed by Roche, the agency said in a same day release. The warnings were added after an FDA review found 13 reports of severe liver injury with orlistat - only one of which was associated with alli (1"The Tan Sheet" Aug. 31, 2009). The agency did not confirm a cause-and-effect relationship between the drug and liver injury, but GSK said it "takes all adverse events reports seriously ... [and] wants people to have the information they need to choose the right weight-loss aid for their situation.
Advisory committee to evaluate FDA's orlistat review
The Pediatric Advisory Committee's March 22 meeting 1agenda includes a "brief follow-up" on FDA's August 2009 "early communication" letter concerning orlistat, the active ingredient in the OTC weight-loss drug alli (60 mg) and Rx Xenical (120 mg). FDA received 32 reports of serious liver injury in patients taking orlistat between 1999, when it first approved Xenical, and 2008; FDA approved alli in 2007 (2"The Tan Sheet" Aug. 31, 2009). The meeting in Bethesda, Md., will include safety reviews on oral and topical drugs for children. FDA will accept written submissions for the meeting through March 8. Oral presentations from the public are scheduled for 1 p.m. to 2 p.m. Requests to make presentations are due by Feb. 28
Glaxo Adds Alli Warning Label In Europe
The European Union health authority recommended GlaxoSmithKline add a warning to alli nonprescription weight-loss drug, advising patients taking levothyroxine or antiepileptic drugs, or those with kidney disease, to consult a doctor before using