FDA Panel Votes to Approve Scary Diet Drug

Illustration for article titled FDA Panel Votes to Approve Scary Diet Drug

An FDA panel voted today to recommend approval of the weight-loss drug Qnexa, despite concerns that it causes birth defects and heart problems — and the fact that some consumer watchdogs are against the drug.


According to the AP, the FDA panel voted 20-2 for the drug's approval, citing the fact that it helped many patients lose 10% of their body weight. This apparently outweighed the drug's side effects, which could include memory loss, depression, heart problems, and an increased risk of having a baby with a cleft palate that persists even if women stop the drug before they get pregnant. The consumer advocacy group Public Citizen said in a press release that Qnexa "causes increased heart rate and may lead to severe cardiovascular problems, such as heart attacks and arrhythmias, as well as birth defects, kidney stones, decreased bone mineral density and memory impairment." Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, says,

Public health cannot tolerate yet another drug approval for a diet drug not accurately assessed for cardiovascular risks, especially in light of suggestive findings of such risks with Qnexa. The danger of another approved diet drug hitting something vital –- the cardiovascular system –- is no longer acceptable when it could be prevented by a large clinical trial powered to evaluate such risk prior to approval.

But the FDA panel apparently sided with the testimony of folks like Dr. Arya Sharma, obesity researcher and paid consultant to Vivus, who said, "Back in medical school, I was taught that when the risk of not treating the condition exceeds the risk of treating it, we should treat. We have an obligation to change how we measure obesity. Qnexa addresses an urgent and substantial unmet medical need for our patients." It's good to know the FDA takes its cues from such impartial observers. The panel may also be feeling pressure from above — some say Congress is trying to get the FDA to approve more obesity drugs. Whatever the case, the full FDA still has to vote on approval in April, but for now, the outlook is pretty good. Or, depending on your point of view, bad.

FDA panel overwhelmingly backs previously rejected anti-obesity pill Qnexa [AP, via MinnLive]
Qnexa Proponents Ask U.S. Experts To Back The Obesity Drug [Reuters, via Huffington Post]

Image via Kati Molin/Shutterstock.com


Seize: it's about ethics in gossip journalism

I guess I have to eat my hat. They're approving Qnexa.

I work in drug development and work is going to be on fire tomorrow. This is unexpected and it's going to turn the race for anti-obesity agents inside out and backwards.