GSK Consumer Healthcare to Update alli Label as FDA Completes Safety Review of Orlistat

PARSIPPANY, N.J., May 26 /PRNewswire/ -- 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.

For more information about the safety and efficacy of alli, consumers and health care professionals may call 1-800-671-2554 or visit www.myalli.com.

About alli

alli is the only FDA-approved weight-loss product available to overweight adults, 18 years or older, without a prescription.  It combines a clinically-proven product with a comprehensive individualized action plan. People who use alli can lose 50 percent more weight than diet alone. The alli program encourages gradual weight loss, known by experts as the best way to lose weight. alli (60 mg orlistat capsules) is safe and effective when used as directed.

About GlaxoSmithKline Consumer Healthcare

GlaxoSmithKline Consumer Healthcare is one of the world's largest over-the-counter consumer healthcare products companies. Its more than 30 well-known brands include the leading smoking cessation products, Nicorette®, NicoDerm® CQ and Commit® as well as Abreva® and many medicine cabinet staples, including, Aquafresh®, Sensodyne,® Tums® and Breathe Right®.

About GlaxoSmithKline

GlaxoSmithKline -- one of the world's leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For company information visit:  http://www.gsk.com.  

SOURCE GSK Consumer Healthcare

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