Watchdog group calls for ban of well-known diet drug Alli

alli.JPGPublic Citizen, a drug-safety watchdog group, has asked the FDA to ban prescription and over-the-counter forms of orlistat, the active ingredient in Alli.

CLEVELAND, Ohio — Alli — one of the nation’s most marketed over-the-counter weight-loss drugs — is under fire as a new study released this week revealed its key ingredient increases the risk of severe kidney injury.

Public Citizen, a drug-safety watchdog group, sent a 31-page letter to the U.S. Food and Drug Administration Thursday demanding that the agency immediately ban prescription and over-the-counter forms of orlistat, the active ingredient in Alli.

The drugs, the watchdog group said, “expose patients to serious risks that greatly outweigh their minimal clinical benefits.”

When introduced in 2007, Alli was expected to be the next big blockbuster for drug manufacturer GlaxoSmithKline. It is the only over-the-counter weight-loss pill approved by the FDA. But its sales have not met expectations.

Alli works differently than most prescription and over-the-counter weight-loss drugs on the market, which are largely appetite suppressants and metabolism stimulants. Alli blocks the absorption of about 25 percent of the fat a person consumes, according to the company.

To introduce Alli to consumers, GlaxoSmithKline launched an extensive marketing campaign, highlighting a clean, crisp package in television, print and Internet ads. The company created a Web site with an online community for users to swap dieting stories and trade health recipe ideas.

The Web site also offers Alli users a “free, personalized weight loss program designed to help patients build a healthy relationship with food.” The company says that customers who use Alli with a reduced-calorie, low-fat diet can achieve “up to 50 percent more weight loss than dieting.”

Dr. Walter Cha, director of bariatric surgery at MetroHealth System, said he saw the popularity of orlistat rise once it became available over-the-counter.

“A person can watch a commercial about it on TV and then just go to the store and purchase it and more people have tried it,” Cha said. The pill can be found easily at nearly any drug or grocery store in the Cleveland region and, is often the case with drugs that haven’t been banned, will continue to be available.

For example, on Friday, popular grocery chain Giant Eagle said it had no plans to pull Alli from it’s shelves because its policy is to follow FDA guidelines.

Still, MetroHealth’s Cha said people should think twice before buying such products.

“It’s more of a kind of a short term solution,” Cha said. “There are downsides.”

Bodies, Cha said, need a certain amount of fat for the body to function properly and the absorption of certain vitamins depend on the absorption of fat.

GlaxoSmithKline has known about the downsides of orlistat in Alli for years. In April 2006, Public Citizen urged a ban of the prescription form of Alli called Xenical because research in rats demonstrated that orlistat caused the formation of pre-cancerous lesions in the colon. The FDA rejected the petition.

Last year, the FDA approved an increase in label warnings on Xenical and Alli after reviewing adverse reactions to orlistat and also finding symptoms related to severe liver injury.

“This drug does a whole bunch in the way of harming people,” said Dr. Sidney Wolfe, director of the health research group at Public Citizen. The diet pill’s new label warning advised consumers to: “Stop use and ask a doctor if you develop itching, yellow eyes or skin, dark urine or loss of appetite. There have been rare reports of liver injury in people taking orlistat.”

Public Citizen’s most recent outcry comes days after a study published in the Archives of Internal Medicine showed that patients taking orlistat in Ontario, Canada, over several years showed a 2 percent increase in acute kidney injuries within one year of starting the drug.

This week, GlaxoSmithKline defended Alli’s safety. The company also announced that Alli was part of a list of brands it expects to sell by the end of 2011, saying it wants to focus on fast-growing brands.

Apr 16th, 2011 | Posted in Weight Loss
No comments yet.
You must be logged in to post a comment.