FDA Investigating Link Between Liver Injury and Weight Loss Drug Orlistat
The U.S. Food and Drug Administration (FDA) is investigating reports of liver injury in patients taking the weight loss drug orlistat, which is found in the prescription drug Xenical and over-the-counter medication Alli. The FDA is conducting an ongoing analysis of additional data from orlistat manufacturers on suspected cases of liver injury, and no definitive association between liver injury and orlistat has been confirmed.
Between 1999 and 2008, the FDA received 32 reports of serious liver injury in patients taking orlistat. Of these cases, 27 required hospitalization and six resulted in liver failure. Thirty of these reported cases occurred outside the United States.
The most common symptoms of liver injury are yellowing of the skin or whites of the eyes (a condition called jaundice), weakness and stomach pain.
Consumers taking Xenical and Alli should continue taking the product as prescribed or directed but should be aware of the potential risk of liver injury. For more information, visit the FDA's Web site at www.fda.gov/Safety/MedWatch/default.htm.
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