FDA Panel Rejects Rimonabant 14-0: Why?

Is this a post-Avandia knee jerk response or is it a bad drug?

I was more than a little bit surprised that an FDA advisory panel nixed use of the appetite-suppressant rimonabant. The drug acts in the central nervous system to inhibit a cannibus receptor, thereby decreasing appetitie (maybe you didn’t know that people who use marijuana typically have huge appetites). The drug has been available in other countries, including most of Europe for some time under the name Accomplia (it was to be called Zimulti for the U.S. market). Apparently the main concerns are related to the reports of depression and even suicide in some people who have taken the drug (not entirely surprising given the psychological effects of marijuana). Whether these serious side efects of the medication are specific for patients who can be identified as “at high risk” or not remains to be clarified.

Studies have shown that the drug does promote weight loss but the results have been somewhat disappointing, particularly given the enormous enthusiasm for the drug when it was first introduced. Not surprisingly, stock in the company that makes the drug, fell after the FDA announcement.

Where to go from here?

Clearly, the FDA needs more information about the drug’s side effects but I hope they will not summarily reject use of the drug in certain circumstances. For example, perhaps the drug can be used prior to considering bariatric surgery in very overweight patients (e.g, BMIs >40)? In such patients, surgery has many risks and perhaps rimonabant is “the lesser of two evils?”

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