Alli and Xenical Recall Petition Filed Over Risk of Kidney, Liver Problems

The consumer watchdog group Public Citizen has petitioned federal drug safety regulators to remove Xenical and Alli from the market, as the weight-loss drugs may cause damage to the kidney and liver. 

The Public Citizen Xenical and Alli recall petition (pdf) was sent to the FDA on April 14, arguing that the risk of side effects of orlistat, the active ingredient in Xenical and Alli, outweigh any potential weight loss benefits provided.

The petition came days after a study was published in the Archives of Internal Medicine which found that 2% of Xenical users were hospitalized for kidney problems once they started taking the drug.

Xenical (orlistat 120mg) is a prescription medication that was approved by the FDA in 1999. The lower dose Alli (orlistat 60mg) is an over-the-counter weight-loss drug that was approved in 2007. Both drugs are marketed by GlaxoSmithKline, PLC, though Xenical is manufactured by Roche.

Public Citizen says that a search of the FDA’s adverse event database links the medications to at least 47 cases of acute pancreatitis and 73 cases of kidney stones. The non-profit group also claims that studies have shown that neither drug is any more effective than diet and exercise.

“Any one of these serious risks alone would be sufficient basis for banning Xenical and Alli,” Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said in a press release. “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.”

In May 2010, the FDA issued a drug safety communication about possible liver problems with Alli and Xenical, indicating that the agency had received at least 13 reports of severe liver injury among users. In two of the cases, the patient died, and three required liver transplants. All but one of the reports came from users of the prescription Xenical, not the lower-dose version that is sold over-the-counter as Alli.

Xenical and Alli are intended for use together with a reduced-calorie diet. They work by preventing the absorption of fats, thereby reducing caloric intake. In 2008, Xenical generated sales of $30 million and Alli generated sales of $131 million during its first full year on the market.

The Alli and Xenical recall petition is the second time Public Citizen has tried to have the orlistat-based drugs pulled from the market. In April 2006 the group called for a Xenical recall because of pre-cancerous lesions that formed on the colons of rats given the drug, but the FDA rejected the petition.