FDA petitioned to remove Alli, Xenical

WASHINGTON, April 15 (UPI) -- The over-the-counter weight-loss drug Alli and its prescription form Xenical should be removed from the U.S. market, a non-profit consumer advocacy group says.

Dr. Sidney Wolfe, director of Public Citizen's Health Research Group in Washington, says both drugs are forms of orlistat -- Xenical has 120 milligrams and Alli has 60 mgs.

Public Citizen petitioned to the FDA to remove immediately from the market Alli and Xenical because they not only can damage the liver but, based on new information obtained from FDA adverse reaction files, have been associated with 47 cases of acute pancreatitis and 73 cases of kidney stones.

"Any one of these serious risks alone would be sufficient basis for banning Xenical and Alli," Wolfe says in a statement. "These drugs have the potential to cause significant damage to multiple critical organs, yet they provide meager benefits in reducing weight loss in obese and overweight patients. For this reason, the FDA should tell the manufacturers of these drugs, Hoffman-LaRoche and GlaxoSmithKline, to pull Xenical and Alli, respectively, from the market immediately."

Public Citizen petitioned in April 2006 for a ban of Xenical because research in rats showed orlistat caused the formation of pre-cancerous lesions in the colon. The FDA rejected that petition.