FDA Looking Into Liver Problems With Obesity Drug Orlistat

The Food and Drug Administration just announced that is has opened an investigation into reports of liver failure, liver disease, and related problems in people taking the obesity drug orlistat.

Orlistat is available by prescription under the brand name Xenical and over-the-counter as Alli, the FDA said. Xenical was FDA approved in 1999, while the lower-dose version, Alli, debuted in the United States in 2007.

The drug is used for obesity management along with lower-calorie diets and to reduce the risks of regaining weight after weight loss.

Dozens of Liver Injuries Reported

From 1999 through October 2008, there were 32 reports of serious liver injury, including six of liver failure, in orlistat patients, the FDA said. Only two of the 32 reports occurred in the United States, with the rest reported in Europe.

The most common side effect reported in the liver injury reports were jaundice, abdominal pain, and weakness. Other symptoms reported included abdominal pain, nausea, vomiting, light-colored stools, itching, and loss of appetite. In 27 of the reported cases, the patients required hospitalization for treatment of the complications, the FDA said.

The FDA’s investigation of liver injuries from orlistat is ongoing and the agency is still collecting data on reports, officials said. In the meantime, patients who are taking orlistat are not advised to stop doing so. Consumers should continue to take Xenical and Alli as directed unless otherwise instructed by their physicians, the FDA said.

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