1st over-counter diet pill approved
Use requires other weight-loss steps
WASHINGTON -- The Food and Drug Administration yesterday approved the first diet pill for sale without a prescription in a marketplace dominated by unregulated over-the-counter supplements that promise weight loss.
Alli can result in modest weight loss if used in conjunction with exercise and a low-fat, reduced-calorie diet. The FDA said that in GlaxoSmithKline studies, about 28 percent of those using the drug shed 5 to 10 percent of their body weight. But Dr. Charles Ganley, the director of the FDA's Office of Non-Prescription Products, emphasized that without diet and exercise, Alli would not be effective. "The emphasis in the labeling is on that," Ganley said.
People with diabetes and those who use blood-thinning drugs will be told to consult a physician before taking Alli, and because of the potential for drug interactions, people with transplanted organs will be warned not to use the treatment. The label also recommends taking a multi vitamin at bedtime to offset nutrient loss.
Alli works by reducing the amount of fat the body absorbs -- about 150 to 200 calories worth per dose -- and ferrying it out of the body. It comes in capsule form and can be taken up to three times daily. The most common side effects are gastrointestinal, including gas, oily spotting, loose stools, and bowel movements that are difficult to control. A low-fat diet helps minimize some of the side effects, the FDA said.
Unlike other over-the-counter products, which can be used by consumers as young as 12, the FDA approved Alli for sale only to those who are at least 18 years old. The agency, however, stopped short of restricting access to the drug through such measures as requiring that it be placed behind a pharmacist's counter or requiring proof of age at purchase. The FDA does not endorse its use by adolescents and GlaxoSmithKline has agreed not to target that group. Safety risks associated with improper use, even by adolescents, were "quite low," Ganley said.
Consumers will begin seeing advertising for Alli as early as mid-April. The goal of the GlaxoSmithKline marketing campaign is to ensure that the right consumers purchase the product, said Steven Burton, vice president for the company's weight control division. "They have to make some lifestyle changes," he said.
The FDA approved orlistat, as the drug is known generically, in 1999. Roche Holding AG continues to sell the prescription version, under the name Xenical, at higher doses. Globally, Xenical sales grew in 2006, Roche reported, aided by an increasing awareness of the health risks associated with obesity. GlaxoSmithKline, through an agreement with Roche, sells prescription Xenical in the United States. GlaxoSmithKline's Burton could not say how much of the diet pill market the new drug could capture. But consumers already spend $23 billion on weight-loss remedies -- including diet pills, shakes, and prepared meals -- and the nation's obesity epidemic is worsening. "Given the size of the problem we have," Alli could prove to be a "significant" commercial and public health success story, Burton said.
If so, it would defy the odds. Overweight consumers have tried -- and rejected -- potential "magic bullet" diet remedies in the past. Alli's impact on weight loss is "modest," acknowledged Dr. Alastair Wood, who served as the chairman of the FDA advisory panel that in January 2006 voted in favor of the agency's approval of over-the-counter sales. "I don't think consumers should view this as a crutch to avoid diet and exercise," Wood said.
Diedtra Henderson can be reached at dhenderson@globe.com. 