FDA panel backs weight loss drug, despite risks
A panel of advisers to the Food and Drug Administration overwhelmingly backed approval for diet pill Qnexa on Wednesday, two years after it rejected the drug because of potentially dangerous side-effects.
Now, CBS News medical correspondent Dr. Jonathan LaPook reports, Qnexa could become the first new prescription drug to treat obesity in more than a decade.
Mariel Rosenwasser is like many of the 190 million obese and overweight Americans struggling to lose weight.
"I had tried many different methods - Weight Watchers, Jenny Craig," said Rosenwasser. "I tried working out, going to the gym and anything I tried didn't seem to work."
FDA weighs pros and cons of Qnexa
But two years ago, when Rosenwasser was pushing 200 pounds, her doctor put her on a combination of two diet drugs.
"Within the first year I lost over 50 pounds, which was incredible," she said. "I think that the most important thing is that I've actually been able to keep it off."
The combination that finally worked for her may soon be available in a single pill known as Qnexa. It failed to win advisory committee approval in 2010 because of two ingredients. Phentermine, an ingredient, in the failed diet drug fen-phen was linked to heart problems. The other, topiramate, was linked to birth defects.
Dr. Kenneth Burman is on the panel that recommended approval to the FDA.
"The risks of the medication are real but the potential benefits seem at this time to trump side effects but in truth only time will tell," Burman said.
The benefits of Qnexa include up to 15 percent weight loss, lowering the risk of problems like diabetes and high blood pressure.
The University of Alabama at Birmingham's Dr. Tim Garvey led the clinical trials.
"We don't have a medication right now like Qnexa," Dr. Garvey said. "A tool like this, we can use to help patients lose significant amounts of weight. I can tell you my patients are looking for a medicine like this."
The drugmaker Vivus has agreed to continue to monitor patients for potential heart problems, and to warn women not to get pregnant. A final decision by the FDA is expected in April.
