Treatment Online

Update: FDA Advisers Reject Anti-Obesity Drug
> 6/14/2007 10:40:06 AM

In an update of Tuesday's report on supposed links between the pending pharmaceutical fat-fighter Zimulti (generic name rimonabant) and depression, anxiety, and suicidal ideation, the FDA's advisory panel has voted 14-0 to reject the drug's appeal for approval, citing uncertainty about its negative side-effects. While the FDA's final decision will not be delivered until July 24, the possibility of them breaking rank and turning against this unanimous decision is extremely unlikely.

In an attempt at compromise, manufacturer Sonofi-Aventis recommended that the FDA prohibit or, at the very least, warn against prescription of the drug to those with a history of depression, anxiety or suicidal thoughts. They argued that the drug did not bring about these symptoms but rather exacerbated pre-existing problems. The board disagreed, noting that the vast majority (88%) of those who reported such disturbances in prescription trials had no previous history of mental health treatments. They also pointed out that warning labels were not likely to stop individuals who suffer from one or more psychiatric disorders from taking the drug, and that such recommendations are difficult to enforce.

The news, of course, is discouraging for Sonofi-Aventis, who may have to further test and possibly alter the drug in the wake of this ruling. But the panel is right to voice serious doubts. A weight-loss drug that threatens to induce such potentially debilitating side-effects cannot hit the market and the homes of the millions who would likely receive its prescription. The health and safety of the consumer is far too important.

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