The Legal Examiner Mark The Legal Examiner Mark The Legal Examiner Mark search twitter facebook feed linkedin instagram google-plus avvo phone envelope checkmark mail-reply spinner error close
Skip to main content

Many of us are trying to find a way to shed a few pounds. Americans have been gaining weight steadily for the last two decades. The Center for Disease Control estimates that 34% percent of adults and 17% of children in America are obese.

That trend may be changing. In February, an FDA advisory panel voted in favor of the approval of an anti-obesity pill known as Qnexa. Good news? Only if you disregard the fact that the drug was previously denied due to safety concerns. In October 2010, when Qnexa was first submitted by the manufacturer, Vivus Inc., the FDA rejected the diet pill due to concerns over side effects such as raised heart rate, psychiatric problems and birth defects. Vivus resubmitted the drug this year with new data in an effort to prove that the drug’s benefits outweigh the risks.

It appears that the advisory panel was impressed with the weight loss results. The clinical trials showed that most Qnexa patients lost nearly 10% of their overall weight after a one year trial of the drug. The panel was so impressed that it seemingly glossed over many of the side effects that the FDA was concerned with in 2010. While stressing the fact that the manufacturer should be required to conduct a large, follow-up study of the pill's effects on the heart, they did barely address the fact that one of the drug’s main components, topiramate, is known to cause birth defects. Instead of requiring additional studies before the drug is approved for sale, it recommended giving Vivus approval to conduct its study after FDA approval. “The potential benefits of this medication seem to trump the side effects, but in truth, only time will tell,” said Dr. Kenneth Burman of the Washington Hospital Center.

The FDA is not required to follow the advice of its panels, though it often does. A final decision on the drug is expected to be made in April. With side effects that could potentially cause death, it seems unfathomable that the FDA is considering an about-face on Qnexa. In my opinion, you can’t solve the problem of obesity by approving a medication with huge potential for other health problems. The loss of extra pounds in exchange for an increased risk of heart attacks, birth defects and psychiatric problems? That’s a tradeoff that I hope we aren’t willing to make.


  1. Gravatar for Sandra

    I think people have to realize that this would not be some magic pill that anyone could go out and get, it would have to be prescribed by a doctor and as such, would only be available to those whose health is in jeopardy due to their weight. I still think there is a lot of concern and that the FDA has to be very careful with this.

  2. Gravatar for Mark Holland MD
    Mark Holland MD

    I have professional experience with phentermine and topiramate for weight loss. It works, but not terribly much better than either drug alone. The main problem, as you rightly point out, is that topiramate is a bit scary. And it's not just because of the fact that it appears to cause cleft palate birth defect, but also because of its sedative effects on the central nervous system. It makes people very well, drunk and impaired even at 25mg per day. Qnexa has "disaster" written all over it.

Comments are closed.

Of Interest