Orlistat is available by prescription under trade name Xenical and over-the-counter as Alli
WEDNESDAY, May 26 (HealthDay News) -- Responding to reports of rare but sometimes severe cases of liver damage, U.S. health officials on Wednesday announced revised labels for a widely used weight-loss drug.
The drug, orlistat, is available by prescription under the trade name Xenical and over-the-counter as Alli.
Thirteen cases of severe liver injury have been associated with taking orlistat, 12 of them overseas and one of them, from Alli, in the United States, according to a statement from the U.S. Food and Drug Administration.
Still, given that some 40 million people worldwide are taking the drug, according to FDA estimates, consumers needn't be too worried about the risk, said Dr. Eugene Schiff, director of the Center for Liver Diseases at the University of Miami Miller School of Medicine.
"The issue here is that they are identifying cases, not many, but some cases of severe liver injury," he said.
"We are telling consumers and health-care providers to be vigilant should [patients] develop symptoms suggestive of liver impairment," said FDA spokeswoman Elaine Gansz Bobo. "We are not advising routine monitoring of liver enzymes as that will not help predict who may develop hepatic impairment on the drug. We were unable to identify any particular group that may be at increased risk."
At this time, FDA officials are only stating that there is an association between the rare side effect and the drug. It's not known if the drug actually causes the problem. It appears that some people simply metabolize the drug differently, putting them at higher risk. It's also possible that a contaminant was introduced, Schiff said.
The FDA first approved orlistat as a prescription medicine in 1999. In 2007, it became the first nonprescription drug approved to treat obesity in American adults.'/>"/>
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