FDA Rejects Weight Loss Drug Due To Hellish Side Effects

Why did the FDA reject weight loss drug Qnexa? Maybe it was the “suicidal thoughts, heart palpitations, memory lapses and birth defects.”

According to the AP, Qnexa makers Vivus Inc. announced yesterday that the FDA had rejected their drug and asked for more information on such potential side effects as “major cardiovascular events,” as well as the aforementioned suicidal tendencies, memory loss, and harm to the fetus. Vivus is sure that all this concern over whether their medication will make you have a heart attack, lose your memory, and/or kill yourself, but not before passing along the damage to your offspring, is all just a big misunderstanding. They said in a statement, “We remain confident in the efficacy and safety profile of Qnexa demonstrated in the clinical development program and look forward to continue working with the FDA towards the approval for the treatment of obesity.” Also, their stock went up after the announcement.

Qnexa is the second weight-loss drug to be rejected this week. The first, lorcaserin, got panned because “FDA officials were concerned about a lack of meaningful weight loss and cancer findings in rats with an unknown impact on people.” Translation: it might not make you lose weight, but it could give you cancer! Also, an existing drug was taken off the market earlier this month for causing heart attacks and strokes. Oddly, a bunch of doctors seem to think the problem here lies not with the drugs that make your heart explode, but with the FDA.

Dr. Tim Garvey, who has done consulting for Vivus, says, “If there isn’t any kind of path forward for this drug I think it is going to shut down all obesity drug development for a decade. Why would a company put all that investment into developing a drug if the FDA signals they aren’t willing to approve it?” Dr. Ken Fukioka, who has also worked with Vivus, told the Times, “It looks pretty bleak out there for anyone trying to get a drug approval for weight loss.” He adds, “It’s tough to be a doctor and try to do something about the biggest problem in the U.S.” I dunno, dude — committing suicide because you took a weight loss drug seems pretty “bleak” too. And is obesity really the biggest problem in the US?

Dr. Caroline Apovian (who has done consulting work for drug makers, natch) says, “We have over 50 antihypertensive agents on the market. We have lots of drugs on the market for diabetes. With the epidemic of obesity, how is it possible that we have only two drugs on the market?” Well, isn’t reducing the risk of health problems like hypertension and diabetes the main reason doctors recommend weight loss? And if we can treat those problems directly in people who suffer from them (and let’s remember that far from all obese people do), doesn’t it make sense that we’re doing that, rather than taking an indirect route that appears fraught with dangerous side effects? Of course, we could also look at ways in which our jobs, our cities, our schedules, and our starkly stratified socioeconomic structure contribute to unhealthy diets, lack of exercise, and all the health problems that go along with these. But that would be difficult, and probably expensive, and apparently as far as Vivus is concerned, a few suicides and birth defects are a small price to pay.

FDA Rejects Second Weight-Loss Drug In A Week [AP, via MSNBC]
F.D.A. Rejects Qnexa, A Third Weight-Loss Drug [NYT]