The over-the-counter weight-loss drug Alli and its prescription form Xenical should be removed from the market immediately, warns Public Citizen, a national non-profit consumer advocacy group based in Washington D.C. The group has petitioned the Food and Drug Administration (FDA) for a ban of the popular drugs, citing evidence that they can cause severe, life-threatening injury to liver, pancreas, and kidneys.
Alli and Xenical are forms of orlistat. Xenical contains 120 milligrams (mgs), while Alli, which is available without a prescription, contains half the amount of orlistat. Public Citizen says that the risks of serious injury far outweigh the drugs’ benefits because neither has been shown to be more effective than diet and exercise. Public Citizen bases its petition on information obtained from the FDA’s adverse reaction data. Files on record show that the weight-loss supplements have been linked to 47 cases of acute pancreatitis and 73 cases of kidney stones.
“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.”
Public Citizen urged the FDA to pull Xenical from the market in a previous petition submitted in April 2006, after discovering that drug research conducted on rats demonstrated that orlistat caused the formation of pre-cancerous lesions in the colon. The FDA rejected the petition.
According to Public Citizen, 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. U.S. prescriptions for Xenical 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. Likewise, sales of Alli have plummeted almost to half of what they were during mid-2007 to mid-2008, the first year of marketing.
Research has shown that 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.
Last year, the FDA issued a warning about “severe liver injury” resulting from orlistat use, citing 12 reports of severe liver toxicity associated with Xenical and one associated with Alli. Two of the injured patients died from their injuries and three needed liver transplants. Of the 47 patients who experienced acute pancreatitis, 39 were hospitalized and one died. Twenty-three of the 73 kidney stone patients were hospitalized for their orlistat injuries. Public Citizen says that of that group, it has identified at least three patients who developed acute kidney failure after calcium salt crystals formed in the kidneys. In one reported case, the patient required dialysis and ultimately died.