Ban Alli, Xenical, Group Urges

Public Citizen is urging the U.S. Food and Drug Administration (FDA) to ban popular weight loss medications <"">Xenical and <"">Alli, over risks to the liver, pancreas, and kidney. The risks, says the advocacy group, outweigh the drugs’ benefits, wrote WebMD.

Xenical’s active ingredient is orlistat, which is also the active ingredient in GlaxoSmithKline’s <"">Alli, the over-the-counter version of the diet drug. Prescription Xenical contains 120 milligrams of orlistat. Alli, sold over-the-counter without a prescription, contains 60 mg of orlistat. The FDA first approved Xenical in 1999, and Alli was approved in 2007. Alli’s maker GlaxoSmithKline, recently announced that it plans to sell its rights to Alli, said WebMD.

Xenical and Alli work differently than other diet medications in that they reduce fat absorption in the body, versus speeding up metabolism or suppressing appetite as other diet aids do.

Public Citizen identified 73 cases of kidney stones in consumers taking Alli or Xenical; 23 needed hospitalization, said WebMD, noting that 47 cases of acute pancreatitis linked to the drugs were found on the U.S. Food and Drug Administration’s (FDA) adverse event reports. WebMD pointed out that this is the second petition Public Citizen has made to the FDA to remove Xenical from the market. The agency rejected the first petition.

Public Citizen director Sidney Wolfe, MD advises consumers not to wait for the FDA. “Stop taking them…. 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 said, quoted WebMD.

“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?” he added. Public Citizen said the average extra weight lost after a year in people taking these orlistat medications, while dieting and exercising when compared to people who dieted and exercised without the drugs, was only 5.6 more pounds for those taking Alli and 7 pounds for Xenical.

Last week, we wrote that Canadian researchers discovered a link to kidney injuries in people taking Roche’s <"">Xenical. The injuries increased with longer usage and the adverse effect is not listed on the drug’s warning label.

Last year we wrote that the safety labels for Xenical and Alli were being modified to include information about potential rare occurrences of severe liver injury in patients, according to the FDA. As of 2010, the popular weight loss medications were used by an estimated 40 million people worldwide. The FDA began a safety review of orlistat in 2009, following reports of 32 cases of serious liver injury, including six cases of liver failure between 1999 and October 2008. Two cases occurred in the United States. For 27 patients, the symptoms were severe enough to require hospitalization.

When the FDA completed its review it ultimately identified 13 total reports of severe liver injury with orlistat. Twelve originated overseas with Xenical and one in the United States involved Alli; two patients died, three required liver transplantation. Because of the severity of liver injury, the FDA said it added information about reported cases of severe liver injury to Xenical and Alli labels.

Patients taking either Alli or Xenical should contact their healthcare professional if they develop symptoms of liver injury, including itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools. Other side effects include the inability to control one’s bowl, stools that are oily or fatty, and oil spotting, said WebMD.

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