FDA panel recommends approval of anti-obesity drug

A FDA panel this week recommended that the weight loss drug Qnexa be approved for sale on the U.S. market.

The pill is only for clinically obese people, and, if approved, would be the most effective legal, non-surgery weight loss method, with trial patients losing about 10% of their weight over a year, the drug manufactuer claims.

Qnexa is a combination of the drugs phentermine, a drug currently approved for weight loss, and topiramate, which is used for the treatment of seizures. It was rejected once by the same committee of doctors in 2010 because of numerous possible side effects, including heart problems and birth defects. However, some doctors already prescribe the combination of drugs in Qnexa to obese patients with separate pills — a practice that is perfectly acceptable.

“I want to emphasize that this is a treatment for obesity, not a weight-loss medicine to lose the last couple of pounds,” said Dr. Louis Aronne, who has prescribed the combination of pills in Qnexa. “We’ve never seen an obesity treatment as effective as this that is not surgery.”

Other weight-loss drugs in the past, like the discontinued drug fen-phen, have provided temporary weight-loss, but patients tend to gain all the lost weight back over time. Qnexa, however, has provided two-year evidence that weightloss was maintained for patients.

“Since the 2010 rejection of Qnexa, we now understand why it’s so difficult for people to maintain their lost weight. There’s a complex hormonal system that pushes weight back up,” Aronne said. “So we have to expect that some weight regain will happen with any kind of treatment for obesity. That’s why diet, exercise, behavioral treatment, is absolutely necessary in addition to using things like surgery or medication.”

Arthur Caplan, a bioethicist, said lifestyle changes are important and too often people rely on a pill while believing they don’t need to change their behaviors or eating habits.

“We can’t turn away from the reality that’s it’s going to take lifestyle change plus some reform of our food policy,” Caplan said. “I mean, I like putting all the blame on the obesity epidemic, so to speak, on the individual, but it isn’t true. We’ve got a culture that is promoting food all the time, and that need to be attended to as well.”

Not all physicians are entirely in favor of Qnexa. In an article on the Huffington Post, Dr. David Katz writes that the approval was based in desperation to have more treatments for obesity in the market and that Qnexa likely isn’t safe for long-term use, because of its side effects.

“It’s a bit harsh, I suppose, but I will nonetheless note that cocaine — another stimulant drug — produces weight loss, too. That doesn’t make it a good idea,” Katz wrote.

A recommendation from an advisory panel does not mean the FDA will necessarily approve Qnexa. However, the FDA usually does follow panel recommendations. Vivus has found reduction in heart attacks and strokes from use of Qnexa, but it will still need to give evidence that it can prolong life. The FDA is expected to make a decision sometime in April.