Public Citizen, in a petition to the FDA, said over-the-drug counter Alli and its prescription form Xenical can damage the liver. The group also said new information obtained from FDA adverse reaction files indicates the drugs have been associated with 47 cases of acute pancreatitis and 73 cases of kidney stones.Both weight-loss drugs contain the ingredient orlistat, which is used to treat people who are overweight and obese. Xenical, which is manufactured by Roche, contains 120 milligrams (mgs) of orlistat, while Alli, which is made by GlaxoSmithKline, contains 60 mgs.
The serious risks of Alli and Xenical greatly outweigh their questionable benefits, Pubic Citizen maintains, because neither has been proven to be demonstrably more effective than diet and exercise.
"Any one of these serious risks alone would be sufficient basis for banning Xenical and Alli," Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a statement. "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."
The petition marks Public Citizen's second attempt to remove Xenical from pharmacy shelves. In April 2006, the group called for a ban on Xenical after research on rats showed that orlistat caused the formation of pre-cancerous lesions in the colon.
Although the FDA rejected the group's previous petition, Public Citizens says U.S. physicians are writing fewer prescriptions for Xenical because of its serious risks and marginal effectiveness.
Prescriptions for Xenical in the U.S. plunged by 81% from 2.6 million in 2000 to just 490,000 in 2007. By 2009, the number of Xenical prescriptions in the U.S. dropped to 110,000 prescriptions, or 4 percent of its peak in 2000. This still exposed tens of thousands of patients to serious risks that greatly outweigh its meager benefits, Public Citizen maintained.
Sales of Alli fell from $145 million from mid-2007 to mid-2008 to $84 million between mid-2009 and mid-2010, the latest years for which data are available.
The day Public Citizen filed its latest petition with the FDA, GlaxoSmithKline issued a press release titled, "GlaxoSmithKline Confirms Alli's Safety Profile," which states:
GlaxoSmithKline (GSK) is committed to ensuring that consumers and physicians understand the safety profile of orlistat and alli. alli is safe and effective when used as directed. . . .GSK continues to proactively monitor for the safety of orlistat and share all relevant information with regulatory agencies. . . .Orlistat, the active ingredient in alli, is the most-studied weight loss medicine. Its safety has been established through 100 clinical studies involving more than 30 thousand patients.
Roche did not immediately respond to Consumer Ally's request for a comment.
The weight lost by users of both prescription and the over-the counter-strength orlistat, Public Citizen points out in its FDA petition, was minimal. People taking Xenical while dieting and exercising for one year lost just over five-and-a-half additional pounds from the 60-mg dose and seven additional pounds from the 120-mg dose compared to a group that took no drugs and only dieted and exercised.
Those in a four-month study of Alli lost only two to four more pounds than those who only changed their diet and exercise routines.
Public Citizen also warned that taking Xenical or Alli may lead to acute pancreatitis, which it said may be difficult to diagnose since orlistat's most common side effects, including abdominal pain and nausea, are also symptoms of pancreatitis.
The group's research of FDA MedWatch adverse reaction reports found 47 cases of pancreatitis associated with Xenical or Alli, with 39 patients requiring hospitalization and one fatality.
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. Public Citizen also identified at least three patients taking orlistat who developed acute kidney failure and one case of a patient who required dialysis and eventually died.