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GlaxoSmithKline to revise alli label as FDA completes safety review of orlistat

GlaxoSmithKline to revise alli label as FDA completes safety review of orlistat

AlliGlaxoSmithKline Consumer Healthcare (GSK) announced it will update the alli product label to alert consumers to certain symptoms that have been associated with rare instances of severe liver injury reported in people taking orlistat, the active ingredient in alli. This update follows FDA's completion of its safety review of orlistat and is being implemented in conjunction with Roche, the manufacturer of the prescription dose of orlistat (Xenical). The agency stated that a cause and effect relationship has not been established.

The updated alli label will advise consumers to: "Stop use and ask a doctor if you develop itching, yellow eyes or skin, dark urine or loss of appetite. There have been rare reports of liver injury in people taking orlistat."

"GSK is committed to ensuring that consumers and physicians understand the safety profile of orlistat and alli. Although reports of serious liver injury in people taking orlistat are rare, GSK takes all adverse events reports seriously. Reaching and maintaining a healthier weight is one of the most important things people can do for their health. GSK wants people to have the information they need to choose the right weight loss aid for their situation," said Howard Marsh, M.D., Chief Medical Officer for GSK Consumer Healthcare.

SOURCE: GlaxoSmithKline Consumer Healthcare


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