U.S. health experts to review OTC weight-loss drug
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U.S. health experts on Monday will weigh what could become the first nonprescription weight-loss drug approved for use in the United States, where nearly two thirds of the population is overweight and obesity rates continue to rise.
The drug, GlaxoSmithKline’s low-dose version of Xenical, will come before a U.S. Food and Drug Administration advisory panel for discussion about whether to allow over-the-counter sales.
Known generically as orlistat, the drug helps prevent fat from being absorbed by the body when taken with meals three times a day.
Prescription-strength Xenical has not been a big seller, in large part because of side effects that can cause excess gas and uncontrollable bowel movements. Its main rival, Abbott Laboratories Inc.‘s Meridia, works by suppressing appetite.
Glaxo, which bought U.S. rights for nonprescription Xenical from Roche Holding AG last year, has argued the half-dose version lessens such side effects, which can also be managed by eating less fat.
Making the drug available without a prescription will make it easier for overweight Americans to seek treatment, Glaxo has said. While numerous dietary supplements and other products are aimed at consumers who want to lose weight, there is no FDA-approved nonprescription treatment.
Government statistics indicate that about 65 percent of Americans are either overweight or obese, which can lead to diabetes, high blood pressure and other complications.
“Even modest amounts of weight loss, if achieved on a widespread basis, could have important public health benefits,” Glaxo officials wrote in documents released Friday ahead of the meeting.
Still, the company acknowledged “the efficacy of any weight loss therapy is inherently tied to lifestyle changes,” saying it would give consumers information about healthy eating.
In separate documents, FDA reviewers expressed concern that some consumers may not be able to tell whether nonprescription Xenical was safe for them.
People also regained weight once they stopped using it, the staff noted.
Later on Monday, the FDA advisors will hear from both the company and agency staff, before discussing the drug’s benefits and risks. The FDA will weigh their recommendation before making its final decision.
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