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WASHINGTON, May 26 (UPI) -- The U.S. Food and Drug Administration has approved a new label for Xenical and Alli to include information about rare, but possible, severe liver injury.
"Xenical and Alli are medications used for weight-loss that contain different strengths of the same active ingredient, orlistat," the FDA said. "Xenical (orlistat 120 mg) is available by prescription and Alli (orlistat 60 mg) is sold over-the-counter without a prescription."
The federal agency said healthcare professionals should weigh the benefits of weight-loss with the potential risks associated with Xenical and Alli before prescribing or recommending the medications to their patients.
The FDA said patients should stop use of orlistat and contact their healthcare professional if they develop the signs and symptoms of liver injury, including itching, yellow eyes or skin, dark urine, light-colored stools, or loss of appetite.
Xenical is manufactured by Genentech USA Inc., while Alli is manufactured by GlaxoSmithKline plc.
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