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FDA Conducting Safety Review Of Weight Loss Drug

Review includes both prescription drug Xenical and OTC drug Alli

By James Limbach
ConsumerAffairs.com

August 25, 2009

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The Food and Drug Administration (FDA) is reviewing adverse event reports of liver injury in patients taking the weight loss drugs Xenical and Alli, also known as orlistat.

Between 1999 and 2008, the FDA received 32 reports of serious liver injury in patients taking orlistat. Of those cases, 27 reported hospitalization and six resulted in liver failure. Thirty of the adverse events occurred outside the United States. The most commonly reported adverse events included yellowing of the skin or whites of the eyes (jaundice), weakness, and stomach pain.

ConsumerAffairs.com has received two reports of adverse effects of the drug.

• Terry of Deer Park, New York says, "the product Alli caused extreme stomach pains and the company is denying anyone else having this symptom. I tried to enter a warning on the message board of their website as a member of the program and was denied entry stating that my message was too negative to post. I am still experiencing problems with stomach pain and don't know yet if Alli has caused permanent damage to my body."

• Diana of Glen Allen, Va., tells ConsumerAffairs.com, "I used Alli pill diet product to lose weight and after 3 day a got costocondritis (my heart muscles were tide) and got big medical bills that I can not afford to pay for it. The product is approved for FDA? I get better when stop having Alli pill."

The FDA is reviewing additional data submitted by orlistat manufacturers on suspected cases of liver injury, and the issue has been discussed at the FDA's Center for Drug Evaluation and Research Drug Safety Oversight Board.

"The issues here are complex, but FDA has benefited from the input of the Board, including comments from representatives from three FDA Centers and several other Agencies in the Department of Health and Human Services," said Steven Osborne, M.D., executive director of the Board.

The FDA's analysis of these data is underway, and no definite association between liver injury and orlistat has been established at this time. Consumers taking Xenical should continue to take it as prescribed, and those using over-the-counter Alli should continue to use the product as directed.

The FDA will release its findings as soon as the review is completed.

Consumers who have used the drugs should consult a health care professional if they experience symptoms possibly associated with development of liver injury, particularly weakness or fatigue, fever, jaundice, or brown urine. Other symptoms may include abdominal pain, nausea, vomiting, light-colored stools, itching, or loss of appetite.

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