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April 14, 2011  

Weight-Loss Drugs Alli and Xenical Should Be Removed From the Market, Public Citizen Tells FDA

Xenical and Alli Can Cause Severe Injury to Liver, Pancreas, Kidneys

WASHINGTON, D.C. – The over-the-counter weight-loss drug Alli and its prescription form Xenical should be removed from the market immediately because they not only can damage the liver, but also, 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, Public Citizen said today in a petition to the Food and Drug Administration (FDA).

 Both drugs are forms of orlistat; Xenical has 120 milligrams (mgs) and Alli has 60 mgs. Their serious risks greatly outweigh their benefits, which are questionable, because neither has been shown to be much more effective than diet and exercise.

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

This is Public Citizen’s second petition to have Xenical taken off pharmacy shelves. In April 2006, Public Citizen urged a ban of Xenical because research in rats had demonstrated that orlistat caused the formation of pre-cancerous lesions in the colon. The FDA rejected that petition.

U.S. physicians have been writing fewer prescriptions for Xenical, even long before over-the-counter Alli was available, because of its serious risks and marginal effectiveness. Prescriptions for Xenical in the U.S. declined 81 percent from 2.6 million in 2000, when Xenical first became available in the U.S., to just 490,000 in 2007. By 2009, the number of Xenical prescriptions in the U.S. further decreased to 110,000 prescriptions, representing only 4 percent of its peak in 2000, but still exposing tens of thousands of patients to a drug with serious risks that greatly outweigh its meager benefits.


Meanwhile, sales of Alli plummeted from $145 million in the first year of marketing (mid-2007 to mid-2008) to $84 million between mid-2009 and mid-2010, the latest years for which data are available.

The weight lost by users of both prescription and the over-the counter-strength orlistat was minimal, Public Citizen said in the petition. For example, people taking Xenical while dieting and exercising for one year (in contrast to those just altering their diet and exercise) lost only 5.6 additional pounds from the 60-mg dose and seven additional pounds from the 120-mg dose compared to the group that engaged only in diet and exercise. Similarly, those in a four-month study of Alli lost only two to four more pounds than those who solely changed their diet and exercise routines.

But the biggest problem with the drugs is their potential to cause serious injuries and death.

On May 26, 2010, the FDA issued a warning about “severe liver injury” resulting from using orlistat. The agency identified 12 foreign reports of severe liver toxicity associated with Xenical and one domestic case for Alli. Two of the patients died of liver failure and three required liver transplants.

Another serious adverse effect of taking Xenical or Alli is acute pancreatitis, which may be especially difficult to diagnose since orlistat’s most common side effects, including abdominal pain and nausea, are also typically symptoms of pancreatitis. Public Citizen’s research of FDA MedWatch adverse reaction reports found 47 cases of pancreatitis associated with Xenical or Alli. Thirty-nine of those patients required hospitalization and one died.

 Public Citizen’s analysis of FDA’s MedWatch reports also identified 73 cases of kidney stones associated with Xenical or Alli use, of which 23 required hospitalization. In a review of the medical literature, Public Citizen also identified at least three patients taking orlistat who developed acute kidney failure because tiny calcium salt crystals formed throughout the kidneys. In one reported case, the patient required dialysis and ultimately died.

Other risks of these drugs include interference with the absorption of fat-soluble vitamins and drugs, fecal urgency, gas with discharge and abdominal pain.

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