FDA APPROVES FIRST OTC WEIGHT-LOSS DRUG
GlaxoSmithKline's Alli became the first OTC weight-loss drug to gain FDA approval, the agency announced.
Alli (orlistat), which comes in 60-mg doses, is indicated for use in adults along with a low-fat, reduced-calorie diet and exercise, the FDA said late Feb. 7. According to the product's labeling, the drug can help patients lose two to three pounds in addition to every five pounds they lose with diet and exercise.
The drug is only intended for use in people who are overweight, with body mass indexes more than 27, the agency said. Orlistat, which works by decreasing the intestinal absorption of fat, will be effective if taken alone, said Charles Ganley, director of the FDA's Office of Non-Prescription Products.
The most common side effect was gastrointestinal problems, the FDA said. The agency added that people with organ transplants should not take the drug because of potential adverse interactions with cyclosporine.
In clinical trials, approximately 28 percent of subjects taking orlistat lost 510 percent of their total body weight in six months, compared with 18 percent of subjects taking a placebo, Ganley said. Approximately 15 percent of subjects taking orlistat lost more than 10 percent of their total body weight over six months, compared with 6 percent of those taking a placebo.
makes a 120-mg prescription dose of orlistat, called Xenical, which gained FDA
approval in 1999. In 2006, the drug had worldwide sales of approximately $558