GSK Consumer Healthcare today 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.
alli is the only FDA-approved over-the-counter weight loss aid. Since alli was made available over-the-counter in 2007, more than 10 million people worldwide have used the product. With more than 100 clinical studies involving 30,000 patients, orlistat is the most extensively studied weight loss drug in the world and continues to be a safe and effective product when used as directed to help people lose weight. More than 40 million people have used orlistat since it first became available in 1998.
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