Alli, Xenical Warning
A popular weight loss drug will be carrying a little more baggage on its warning label.
After 13 cases of severe liver injury, the orlistat label will contain a new warning about the potential of liver injury.
Orlistat is available by prescription as Xenical, and Alli, which is available over-the-counter.
Twelve of the 13 cases of liver damage were overseas and one case, from the use of Alli, was in the U.S.
Among those reports, two individuals died, and three needed a liver transplant.
About 40 million people worldwide have taken or are taking the drug. Dr. Eugene Schiff, a liver specialist at the University of Miami Miller School of Medicine tells Business Week that these cases are rare.
Alli is marketed by GlaxoSmithKline PLC at a lower dose (60 mg), while Xenical, the prescription version is made by Roche Holding AG (120 mg), which plans to monitor Xenical’s safety and says it will share that information with federal regulators.
Signs of liver injury include yellow eyes or skin, dark urine, light colored stools, loss of appetite or itching. Patients should stop using orlistat if they develop any of those symptoms.
"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 who added that routine liver enzyme testing will not help predict who may be at increased risk.
"At this time, a cause-and-effect relationship of severe liver injury with [Xenical or Alli] use has not been established," the agency said in a statement.
Some of the patients experiencing reaction may have been taking other drugs as well.
Approved in 1999, orlistat became the first nonprescription drug to treat obesity in American adults. By 2009, 32 reports of serious liver injury had been reported to the agency includes six cases of liver failure, with two occurring in the U.S. 27 of those patients had to be hospitalized.
In 2006, Public Citizen petitioned the FDA to remove orlistat from the market because “the obesity treatment has been known to cause a significant increase in aberrant crypt foci (ACF), which are widely believed to be a precursor to colon cancer.”
For some, the costs associated with obesity are worth the drug risk. Thirty percent of Americans are considered obese, and another 36 percent are overweight, according to the National Center for Health Statistics. #