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GSK adds alli warning

This article was originally published in The Tan Sheet

Executive Summary

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.

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