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Obesity Drug Linked to Anxiety, Suicidal Thoughts
> 6/12/2007 3:43:44 PM

In an unfortunate setback for promising developments in the pharmaceutical weight-loss research field, the FDA has issued a report linking a new, highly touted anti-obesity drug to psychiatric complications and, in extreme cases, heightened suicide risks.

The drug, which has been in development for some time and is already available for prescription in 18 countries under the name Acomplia, has proven quite successful in earlier trials, with patients consistently losing weight and keeping it off while also showing signs of better-regulated blood sugar and cholesterol levels. If approved, the drug will be marketed in the United States as the potential bestseller Zimulti. It was initially advertised as a double-purpose weight-loss/ smoking cessation aid, but in 2005 officials raised concerns when it came up for approval in that capacity due to a "lack of efficacy" and, again, possible psychiatric side-effects. Interestingly, the drug's major element (generic name rimonabant) is a cannibinoid-1 receptor antagonist, working in a fashion diametrically opposed to the chemical reaction that stimulates hunger pangs when affected by the active components in marijuana.

Unfortunately, patients taking the drug in test trials reported levels of depression and anxiety nearly double that of the placebo group (26% to 14%). 15% of the patients taking the highest dose (25mg) of the drug also discontinued its use due to compaints ranging from anxiety to nausea and insomnia. The suicide risk was slightly less pronounced, with one of the 2500 patients involved in the low (5mg) dosage group dying of self-inflicted injury, but eight other patients reported suicidal thoughts. In a somewhat contradictory instance, two of the patients in the placebo group also attempted suicide during the study period, with an additional five reporting suicidal thoughts. These results leave the direct suicide link in doubt; perhaps another factor was at work here. Obesity has been clearly proven to encourage or complicate depressive states, and would seem a likely source for suicidal ideation on its own. But, strangely, obesity seems to affect the behaviors of the respective genders in nearly opposite ways: women with extremely high BMIs are at greater risk of suicide whereas obese men are less likely than others to harm themselves. The sexes of the study's subjects were not clarified.

While the final verdict on pending FDA approval has yet to arrive, these reports should lead some to temper their optimism regarding this new drug. Further studies may be warranted in determining exactly how great a health risk Zimulti would pose for individuals seeking an efficient weight-loss aid. The vast majority of medications bring with them requisite side-effects, and those present in the Zimulti trials may ultimately prove insufficient to make for a subsequent FDA denial. If the drug wins approval, patients and practitioners should read this report not as a deadly omen but rather as a standard precautionary measure. If the drug continues to prove problematic, further restrictions or recalls will be in order.

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