06-08-2010, 03:04 PM
It's rare, but notable
Concerned about rare occurrences of severe liver injury, the U.S. Food and Drug Administration said Wednesday it is requiring a new warning label on the weight loss drug orlistat, which is marketed as Xenical and Alli.
Xenical is a prescription weight loss drug that contains 120 milligrams of orlistat. Alli, the over-the-counter version, contains 60 mg of orlistat. An estimated 40 million people worldwide have taken either Xenical or Alli, according to the FDA.
The FDA, which began investigating the weight loss drug last year said the warning is based on its review of 13 cases of severe liver injury reported in those taking orlistat. Twelve of the cases occurred outside the country; the only U.S. report of severe liver injury involved Alli.
Signs and symptoms of liver injury include itching, yellow eyes or skin, dark urine, loss of appetite and light-colored stools.
Last year, the weight loss dietary supplement Hydroxycut was recalled in the U.S. after the FDA warned about potential liver damage.
Earlier this year, the FDA warned consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules. The fake versions contained a controlled substance called sibutramine rather than orlistat. Sibutramine should be used only under the care of a physician.
Concerned about rare occurrences of severe liver injury, the U.S. Food and Drug Administration said Wednesday it is requiring a new warning label on the weight loss drug orlistat, which is marketed as Xenical and Alli.
Xenical is a prescription weight loss drug that contains 120 milligrams of orlistat. Alli, the over-the-counter version, contains 60 mg of orlistat. An estimated 40 million people worldwide have taken either Xenical or Alli, according to the FDA.
The FDA, which began investigating the weight loss drug last year said the warning is based on its review of 13 cases of severe liver injury reported in those taking orlistat. Twelve of the cases occurred outside the country; the only U.S. report of severe liver injury involved Alli.
Signs and symptoms of liver injury include itching, yellow eyes or skin, dark urine, loss of appetite and light-colored stools.
Last year, the weight loss dietary supplement Hydroxycut was recalled in the U.S. after the FDA warned about potential liver damage.
Earlier this year, the FDA warned consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules. The fake versions contained a controlled substance called sibutramine rather than orlistat. Sibutramine should be used only under the care of a physician.