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Two recent reports have uncovered a worrying link between the antiobesity drug rimonabant and mental health problems, including suicide, says an editorial (p 1671)1671).. The first, a meta-analysis of four key trials, found that obese people who took the drug were two and half times more likely than placebo controls to stop their treatment because of depression or depressive symptoms (74/2503 (3.0%) v 22/1602 (1.4%); odds ratio 2.5, 95% CI 1.2 to 5.1). They were three times more likely to stop treatment because of anxiety (26/2503 (1.0%) v 5/1602 (0.3%); 3.0, 1.1 to 8.4). In an extended analysis that included smoking cessation trials, the odds ratio for suicide in people taking rimonabant was 1.9 (1.1 to 3.1). All the antiobesity trials excluded patients with existing mental illness. The editorial also details a second report, prepared for the US Food and Drug Administration which found that 26% of patients who took rimonabant had some kind of adverse psychiatric event, compared with 14% of those who took placebo (relative risk 1.9, 1.5 to 2.3)
These data raise serious concerns about the safety of rimonabant, says the editorial, particularly for obese people who are prone to depression. Rimonabant is already available in Argentina, Austria, Denmark, Finland, Germany, Ireland, Norway, Sweden, Greece, and the UK. In the US, the FDA is now asking for more safety data before making a licensing decision.