FDA OKs first nonprescription diet pill
February 9, 2007 8:35am CST
Intended only for people 18 and older, the drug, called alli, is a reduced-strength version of the prescription diet drug Xenical. The Food and Drug Administration on Wednesday announced its approval of sales of the lower-dose drug without a prescription, with officials stressing that it needs to be used in combination with a diet and exercise program. "Using this drug alone is unlikely to be beneficial," said Dr. Charles Ganley, FDA's director of nonprescription products. The new drug will be sold by GlaxoSmithKline PLC and the company said it is expected to be in stores by summer. While the final price has not been determined, it is expected to be about $1- to $2-a-day. Xenical is made by Roche Holding AG. While some dietary supplements make weight loss claims, Ganley said this is the first nonprescription drug approved by the agency for that purpose. Ganley said in trials, for every 5 pounds people lost through diet and exercise, those using alli lost an added 2 to 3 pounds. When taken with meals the drug — known generically as orlistat — blocks the absorption of about one-quarter of any fat consumed. That fat — about 150 to 200 calories worth — is passed out of the body in stools, which can be loose as a result. About half of patients in trials experienced gastrointestinal side effects. The new drug would contain half the dose of Xenical prescription capsules. Also, FDA said people who have had organ transplants should not take over-the-counter orlistat because of possible drug interactions. In addition, anyone taking blood thinning medicines or being treated for diabetes or thyroid disease should consult a physician before using orlistat, the agency said. GSK Consumer Healthcare, which will market the pill, said it chose the name alli — pronounced AL-eye — to indicate a partnership with consumers in their weight-loss efforts. "We know that being overweight has many adverse consequences, including an increase in the risk of heart disease and type 2 diabetes," said Dr. Douglas Throckmorton, deputy director for the FDA's Center for Drug Evaluation and Research. "OTC orlistat, along with diet and exercise, may aid overweight adults who seek to lose excess weight to improve their health," he said. But Dr. Sidney M. Wolfe, director of Public Citizen's Health Research Group called the approval "the height of recklessness." Wolfe said studies have associated the prescription version of the drug with precancerous lesions of the colon. Wolfe had opposed the switch to over-the counter sale, calling the plan a "dangerous mistake in light of its marginal benefits, frequent coexistence of other diseases, common, bothersome adverse reactions, significant inhibition of absorption of fat soluble vitamins."