The Food and Drug Administration (FDA) has approved the first government approved diet pill that can be bought without a prescription. The drug, named alli, is only for people 18 and older. It is a reduced strength version, about half the strength, of the prescription medication, Xenical.
While FDA officials approved the sales of the lower dose diet pill without a prescription, they stressed it should be used in combination with diet and exercise.
Dr. Charles Ganley, the FDA’s director of nonprescription products, said using the drug without diet and exercise would not likely be beneficial.
GlaxoSmithKline PLC will sell the diet pill, which is expected to be in stores by summer. The final price for the medicine has not been determined, but it is expected to be $1-$2 a day. Roche Holding AG makes Xenical.
Some diet supplements make weight loss claims, but Ganley said the FDA has never approved a nonprescription diet pill before. He said that in trials for every five pounds lost through diet and exercise alone, those using alli lost an additional two to three pounds.
The nonprescription diet pill is known generically as orlistat. When taken with meals, it blocks about 25% of any consumed fat. That fat is passed through the body in stools, which often can be loose. The blocked fat is the equivalent of 150 to 200 calories worth. Of those patients using the drug in trials, about half had gastrointestinal side effects.
FDA officials cautioned that those who have had organ transplants should not take the new drug, because of possible interaction with other medications. Those being treated for diabetes or a thyroid condition or taking blood medications should consult a doctor before using orlistat, according to the FDA.
Dr. Douglas Throckmorton, deputy director for the FDA’s Center for Drug Evaluation and Research, said being overweight carries health risks, including a greater chance of heart disease and diabetes. He added orlistat, along with diet and exercise, may help overweigh adults lose weight and improve their health.
Dr. Sidney M. Wolfe, director of Public Citizen’s Health Research Group, however had opposed the FDA action concerning the first nonprescription diet pill and called it “the height of recklessness.” He said studies of the prescription strength of the drug have associated it with precancerous lesions of the colon.
He called the FDA letting the drug be sold as a nonprescription medication was a “dangerous mistake,” because of its marginal benefits. He said the drug frequently exists with other diseases, has adverse reactions, and inhibits the absorption of vitamins.