Consumer Group Warns Not to Use Orlistat Weight Loss Drugs

The consumer watchdog group Public Citizen indicates in the latest issue of their newsletter “Worst Pills, Best Pills” that people should not use the weight loss medication orlistat, which is sold as a Xenical and Alli, due to the minimal benefits provided by the drug compared to the risk of liver damage and other serious side effects.  

In the July issue of its Worst Pills Best Pills newsletter, Public Citizen said orlistat-based drugs have a laundry list of negative side effects in return for weight loss that it categorized as “meager.” Xenical is a prescription weight loss drug containing the active ingredient orlistat, and Alli is a lower-dose over-the-counter version of the medication.

Orlistat side effects have been linked a potenital risk of liver damage, pancreatitis and pre-cancerous lesions of the colon.

In May, the FDA issued a drug safety communication about possible liver problems with Alli and Xenical, indicating that the agency had received at least 13 reports of severe liver injury among users. In two of the cases, the patient died, and three required liver transplants. All but one of the reports came from Xenical users.

Xenical (orlistat 120mg) is a prescription medication that was approved by the FDA in 1999. The lower dose Alli (orlistat 60mg) is an over-the-counter weight-loss drug that was approved in 2007. Both drugs are marketed by GlaxoSmithKline, PLC, though Xenical is manufactured by Roche.

The medications are intended for use together with a reduced-calorie diet. They work by preventing the absorption of fats, thereby reducing caloric intake. In 2008, Xenical generated sales of $30 million and Alli generated sales of $131 million during its first full year on the market.

Public Citizen, a non-profit consumer protection organization, points out that it previously testified against approval of the drug in 1997, and again in 2006 when drug makers were pushing for over-the-counter approval. It has also previously petitioned the FDA for an Xenical and Alli recall to be issued.

“Public Citizen has been concerned about or­listat and opposed to its approval from the very beginning,” the group said in its newsletter. “Orlistat was approved without scientific evidence showing that there is a health benefit for those who use it. In other words, there is no evi­dence that orlistat, or any diet drug, will reduce risk of premature death or illness associated with long-term obesity and inactivity.”

The FDA has previously noted that an estimated 40 million individuals have used the medications, and only one of the reports of liver problems were found in the United States, involving a user of Alli. The remaining 12 cases occurred outside the United States, and involved liver problems with Xenical. The agency indicates that there has been no direct causal relationship established between the two orlistat-based drugs and liver injury.

The primary known side effects of Alli and Xenical include oily and loose stools, fecal incontinence, frequent or urgent bowel movements and flatulence, which tend to be most severe when the treatment is started and may decrease with time.

The FDA has required that new label warnings be placed on the drugs, alerting users to the potential risk of liver injury. The new label changes will warn of rare cases of severe liver injury, and indicate that healthcare professionals and consumers should watch for symptoms of liver injury, including:

• Itching yellow eyes or skin
• Dark urine
• Light-colored stools
• Loss of appetite

Individual consumers have been urged to stop using the drugs and contact their healthcare professional if they develop symptoms of liver damage from the orlistat drugs Xenical or Alli.