Anti-obesity drug may go OTC

A pill that blocks some fat from being absorbed by the body could become the first prescription obesity drug to go over-the-counter.
In late January, a Food and Drug Administration advisory committee will review Glaxo-SmithKline's application to sell a nonprescription 60-milligram dose of orlistat, which is sold as Xenical.
Xenical has been available by prescription in a 120-milligram dose since 1999.
Because Xenical would be the first prescription obesity drug to go OTC, Glaxo probably won't be able to persuade the FDA advisers that the switch is warranted, says industry consultant Steve Francesco.
"Historically, a switch like this has to go through FDA twice," says Francesco, publisher of a newsletter about OTC switches.
Heightened concern about drug safety in this post-Vioxx era means the slightest hint of a problem would be enough to prevent Xenical from going OTC, Francesco says. "Even though it looks very clean, I think something will come up."
This past January, an FDA advisory panel voted 20-3 against recommending approval of OTC Mevacor, a cholesterol-lowering drug. Maker Merck failed to show that consumers properly could decide on their own whether to take the drug, panelists said.
Xenical is available without a prescription in Australia and New Zealand, but it's not OTC. In those countries, Xenical falls into a third category of drugs available only from a pharmacist. The USA has no such "behind-the-counter" drug category.
Xenical keeps about 30 percent of dietary fat from being absorbed by the intestine. It's designed for obese people who have 30 or more pounds to lose or those who have less to lose but also have other health risks, such as diabetes or high cholesterol.
Studies show that patients who are prescribed Xenical and cut about 600 calories a day can expect to lose 5 percent to 10 percent of their weight in six months.
Glaxo's proposal "recommends" that those younger than 18 "seek the advice of their physician."
The company has suggested working with retailers to verify the age of people who want to purchase OTC Xenical, an approach Glaxo already has taken with Nicorette and NicoDerm CQ, used to help smokers quit.
Xenical "has shown to be safe in children, but there are a lot of things we think adults need to supervise, and this is one of them," says obesity drug researcher Louis Aronne, director of the Comprehensive Weight Control Center at New York-Presbyterian Hospital.
"This is far safer" than dietary supplements touted for weight loss, "which either don't work or are risky," says Aronne, who has conducted research on Xenical and prescribes it to patients.