Will the FDA do the right thing and hold Acomplia off the market until further research can be done to determine whether it has serious adverse side effects, including increasing suicidal behavior? This seems to be the signal they are sending. From Business Week:

Regulators on Monday said Sanofi-Aventis’ obesity treatment Acomplia may trigger suicidal behavior and other psychological side effects in some patients.

The Food and Drug Administration posted online its review of the drug — deemed effective for losing weight — ahead of a Wednesday meeting at which outside experts will vote on whether it should be approved. The agency does not have to follow the experts’ vote, though it often does.

FDA is scheduled to issue its final decision on the drug July 27.

Based on clinical studies from the French drug maker, FDA said patients taking Acomplia daily showed significant weight loss after two years.

However, agency staffers raised concerns about an increased rate of psychiatric adverse events among patients taking Acomplia, including depression, anxiety and insomnia. About 26 percent of patients on Acomplia reported such events, compared with 14 percent of patients on placebo.

FDA also drew attention to a possible link between Acomplia and suicidal behavior. In studies of the weight loss drug, Sanofi reported one patient committing suicide and eight having suicidal thoughts. Among patients taking a fake pill, Sanofi reported two suicide attempts and five instances of suicidal thoughts.

I wonder why the people not taking Acomplia also had such high levels of suicidal behavior and thought. Perhaps because they weren’t losing weight as they had hoped? But then the people losing weight had an even higher rate of suicidal thought and behavior, which suggests that the drug may be having adverse side effects, and/or losing weight is not all it’s cracked up to be. Just because you’re thinner, you’re not necessarily going to be happier.

Beyond wondering about the individuals in this study, however, this news has larger implications in terms of the modern practice of creating pharmaceuticals. It suggests that while we experiment away with this drug and that, and combine three drugs at a time in children with behavior problems, we know very little about the chemistry of the body. A drug that is targeting weight loss can throw the entire human organism out of whack, including the brain.

We need to remain vigilant regarding introduction of drugs and be fully informed of all side effects. But first, when possible, we need to seek the behavioral intervention before going for the pharmaceutical intervention. Remember exercise and eating less? Those are the two best ways to lose weight, and both have also proven to have a positive side effects, including reducing depression and increasing overall health and longevity.