DENVER — A new diet pill is one step closer to gaining FDA approval, and, if approved, Qnexa would be the first new prescription diet pill approved in 13 years.
An independent panel of doctors and other experts voted in favor of approving Qnexa Wednesday.
Qnexa is a combination of two other drugs already on the market, phentermine and topiramate.
“The study looked at 2,500 people over a two year period of time,” explained Dr. Jeffry Gerber. “And what they found with this new drug was that there was a 9 percent weight loss compared to placebo.”
The FDA denied approval for Qnexa in 2010 citing concerns related to the topiramate, which is a commonly used anti-convulsant often sold under the name Topamax.
“For pregnant women taking Topamax, there was an increased incidence of birth defects and cleft palate,” Gerber said.
The drug’s creators propose a strict system for prescribing Qnexa, specifically advising monthly pregnancy testing for women. There have also been questions about phentermine, which is famously associated with the diet drug Fen-Phen which was shown to cause heart valve problems.
“I associate that with all those horrible stories from the 90s about people who died,” said Rebecca Ensley.
But Gerber said it was the other “fen,” fenfluramine, which was the problem.
“This drug doesn’t seem to have any problems related to that,” he said. “I don’t think the heart issues with the phentermine are particularly concerning.”
But even with FDA approval, horror stories like Fen-Phen have many unsure about using diet pills at all.
“Having taken diet pills in the past, I know what side effects they can have on you,” Ensley said.
“If something in it already has a warning, I think that would probably be a big sign to deter me from taking it,” said Alix Peterson.
And unfortunately, there’s no such thing as a miracle drug.
“People hear about these drugs and they look at it as a silver bullet, they look at it as the solution,” Gerber said. “But eventually their effect wears off, no matter how long you use it.”
The FDA has until April to make a decision on approving Qnexa.