Washington – Federal health advisers voted Monday to recommend over-the-counter sales of a weight-loss pill now sold only with a prescription.
GlaxoSmithKline Consumer Healthcare still needs final Food and Drug Administration approval before it can sell a nonprescription version of orlistat, a diet pill already marketed in prescription form as Xenical. The FDA approved the prescription version of the fat-blocking pill made by Roche in 1999.
A joint FDA advisory committee voted 11-3 to recommend approval late Monday after a day-long hearing. The agency usually follows the recommendations of its outside panels of experts, but its final decision could take months.
If approved, orlistat would be the first weight-loss drug sanctioned for over-the-counter sales.
In six-month clinical trials, obese people who took orlistat lost on average 5.3 pounds to 6.2 pounds more than those who were given dummy pills.
Glaxo wants people to use it for only six months at a time, but as an over-the-counter item its use could not be policed.
The pill’s effect ends once its use is stopped, said Dr. Julie Golden, an FDA medical officer.
A previous study showed a progressive weight gain in patients after they discontinued use of orlistat, Golden said.
