Public Citizen Calls for Ban on Alli

Washington, DCFor patients desperate to lose weight, the risk of Alli side effects may not be all that much of a concern. After all, the risks associated with being overweight include diabetes, heart disease and other serious health problems. But for some people, the risk of side effects associated with Alli, known generically as orlistat, are simply too high. These orlistat side effects have resulted in at least one organization—Public Citizen—calling for a ban on the medication.

In April 2011, Public Citizen issued a petition to the US Food and Drug Administration (FDA) to request the removal of Alli and Xenical, which is made from the same active ingredient as Alli. Public Citizen noted that because of serious side effects, which include liver damage, kidney stones and pancreatitis, the benefits of Alli and Xenical no longer outweigh the risks.

"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," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group.

Alli was approved in 2007 as an over-the-counter version of Xenical, which was available by prescription. The drugs work by blocking the absorption of up to one-third of certain enzymes that enter the body, allowing fat to pass through the body, according to ABC News (04/14/11). The FDA reportedly received 47 reports of acute pancreatitis and 73 reports of kidney stones linked to orlistat.

One patient told ABC News that she took Alli four times before noticing signs of liver failure, but when she was admitted to the hospital, she was told she had 48 hours to live and required a liver transplant to save her. The patient says she was told by doctors that orlistat caused her liver problems.

In 2006, Public Citizen sent a petition to the FDA requesting that orlistat be removed from the market because a study in rats suggested the medication was linked to pre-cancerous lesions in the colon. The FDA rejected that petition.

In its most recent petition, Public Citizen (04/14/11) notes that studies have shown orlistat weight-loss benefits are minimal compared with diet and exercise alone. According to the organization, patients who took 60 mg of Xenical for one year, while also dieting and exercising, lost only 5.6 pounds more than patients who dieted and exercised but did not use the medication. Meanwhile, patients who took the 120-mg dose, along with diet and exercise, lost only seven pounds more than patients who used diet and exercise without medication.

On May 26, 2010, the US FDA issued a warning about severe liver injury associated with orlistat. The agency received 12 reports of severe liver toxicity associated with Xenical and one associated with Alli. Those reports included two in which the patient died and three in which the patient required liver transplants.