FDA Panel Approves Diet Pill

Final Approval Likely For Over-The-Counter Sales Of Low-Dose Xenical

(CBS/AP) 
Dr. Sidney Wolfe of the watchdog group Public Citizen urged the panel to reject the company's application, calling it a "desperate attempt to revive this barely effective drug by an OTC switch."

Deborah Fisher, a nurse from the Baltimore area, told the panel: "We need this new solution to losing weight and keeping it off."

"Eat less, move more: It sounds pretty simple, doesn't it? Well, as my kids say, not!" said Fisher, adding that she's dieted for 45 of her 52 years.

The proposed over-the-counter orlistat pill, called Alli (pronounced "ally"), would contain half the dose of the prescription capsule.

Alli could cost consumers $12 to $25 a week, Glaxo said. The company estimated 5 million to 6 million Americans a year would buy the drug if offered over the counter. Those numbers could mean at least $1.5 billion a year in retail sales.

On Monday, FDA panel members questioned whether consumers would be able to distinguish Alli from non-approved dietary supplements also sold as weight-loss aids. They also expressed concern about its effect on vitamin intake. Half of the patients enrolled in trials of the drug failed to understand labeling directions that they should take supplemental vitamins at least two hours before or after using the pills.

The drug also could cause problems for organ transplant patients taking the drug cyclosporine as well as those on warfarin, a blood thinner. The drug's label would warn such patients against taking the weight-loss pill.

When taken with meals, orlistat blocks the absorption of about one-quarter of any fat consumed. That fat — the equivalent of about 150 to 200 calories — is passed out of the body in stools, which can be loose or oily as a result. Other side effects include gas, incontinence and oily spotting. About half of patients in trials experienced such side effects, the company said.

Furthermore, just 35 percent of diabetes patients in a study correctly stated that the drug was inappropriate for them, according to FDA documents.

Those results worried FDA reviewers, who questioned the risk of selling the drug directly to consumers "without the principal involvement of a learned intermediary," or prescribing doctor.

The reviewers also expressed concern about the increased potential for abuse or misuse of a prescription-free version of the drug, especially among bulimics or binge-eaters who could develop vitamin deficiencies due to chronic use.

The company said there was a "very low" potential for abuse, with only four published reports of bulimics using the drug. More than 22 million people worldwide have used orlistat in prescription form.

British-owned GlaxoSmithKline's U.S. operations are based in Philadelphia and Research Triangle Park, N.C.