Team McCallum

R&D for Lifetime of Life

FDA adds warning to Xenical/Alli.

The FDA announced yesterday that the weight-loss medication orlistat, marketed both by prescription as Xenical (120 mg) and over-the-counter as Alli (60 mg), will carry a warning about the potential for severe liver injury.

This follows a review by the FDA of 32 reports of serious liver injury, all but 2 outside the US.

An estimated 40 million people worldwide have used the two drugs.

“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,” the announcement read.

In a comment on the announcement, Dr Peter Anyakora recommended that liver and pancreas tests should be done before prescription, then monthly.


May 27, 2010 - Posted by | FDA, Obesity, Orlistat, Weight management

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