Group Calls on FDA to Pull Alli, Xenical

April 15, 2011 -- The consumer advocacy group Public Citizen is urging the FDA to immediately pull two weight loss drugs, Xenical and Alli, from the market. The group says the drugs’ risk for liver, pancreas, and kidney damage greatly outweighs any potential weight loss benefits.

Xenical and Alli are different strengths of the drug orlistat. Prescription-strength Xenical is manufactured by Roche. Alli is available over the counter, and is one-half the strength of Xenical. These drugs block the absorption of fat in the gastrointestinal tract. Alli manufacturer GlaxoSmithKline announced plans to sell  the rights to the over-the-counter drug Alli.

In May 2010, the FDA issued a warning based on post-marketing adverse events about risk of severe liver injury in people taking orlistat, citing 12 foreign reports of liver toxicity with Xenical and one case of liver toxicity in the U.S. associated with the use of Alli. Two of these patients died, and three needed liver transplants as a result of this damage.

Washington-D.C. based Public Citizen has now identified 73 cases of kidney stones linked to use of these drugs, 23 of which required hospitalization, along with 47 cases of acute pancreatitis from the FDA adverse event reports. This is Public Citizen’s second petition to have Xenical removed from the market. Their first petition was rejected. The FDA will now mull the new petition.

If you are taking these drugs, don’t wait for the FDA to act, says Public Citizen director Sidney Wolfe, MD.

“Stop taking them,” he says. “Unlike other drugs, which have a withdrawal syndrome that you would go through if you suddenly stop, there is no downside to stopping Xenical or Alli.

“The risks greatly outweigh the benefits,” he says. “The drug doesn’t add all that much to weight loss efforts. This has got to be the end of the drug. How much more danger do you need for a drug that doesn’t work very well?”

According to Public Citizen, the average additional weight loss after one year among people taking orlistat while dieting and exercising compared to those who just did diet and exercise was 5.6 additional pounds with the 60 mg dose and 7 additional pounds with the 120 mg dose. The drugs are also known to cause other mild side effects, including inability to control bowel movements, oily or fatty stools, and oily spotting.

Industry Responds

“Patient safety is of the utmost importance to Roche, and we regularly monitor the safety profile of all our medicines and provide this information to the FDA,” Roche spokesman Christopher Vancheri says in a written response. “Roche has not yet had the opportunity to thoroughly review the Public Citizen petition and therefore, cannot make any further comments.”