“The Food and Drug Administration said Wednesday it has added a warning about the risk to the label of the drug, which is sold over-the-counter by GlaxoSmithKline. A prescription version called Xenical is manufactured by Roche and sold by Glaxo.”
Currently the FDA has identified 13 confirmed cases of liver damage linked to Alli and Xenical. Xenical has been on the market since 1997 and available via doctor’s prescription. Alli, a newer consumer version of the weight loss drug, has been available over-the-counter since 2007.
Alli, which had sales nearing 300 million dollars in 2009, has been performing below Wall Street estimates. Poor sales of the lifestyle drug can be attributed to poor economic conditions as well as unpleasant side effects, such as anal leakage.
Doctors urge patients taking these weight loss pills to monitor signs of liver injury, including itching, yellow eyes and skin and loss of appetite.