Prescrire international
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Benfluorex is an amphetamine appetite suppressant derived from fenfluramine. In France, about 30 cases of pulmonary arterial hypertension and a similar number of valve disorders, often involving several valves, were reported between 1998 and 2009. ⋯ The French National Pharmacovigilance Committee simply proposed "to await the results of planned and ongoing studies". However, it would be in patients' best interests to withdraw this drug from the market.
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(1) When an antidepressant is considered a necessary addition to psychological support in treating patients with depression, the first-line drug is a tricyclic such as clomipramine or a selective serotonin reuptake inhibitor (SSRI) such as paroxetine; (2) Agomelatine, a melatonin receptor agonist, is approved in the European Union for the treatment of depression; (3) Available evaluation does not include any clinical trials designed to compare the efficacy of agomelatine with that of a tricyclic or a selective serotonin reuptake inhibitor. Most data come from 7 placebo-controlled trials; (4) Agomelatine (25 mg/day) was statistically more effective (on a rating scale) than placebo in only 3 of these 7 trials. The clinical relevance of the score improvements is questionable. ⋯ Dizziness, gastrointestinal and cutaneous disorders have been observed. Agomelatine is probably hepatotoxic; (8) In summary, agomelatine has unproven efficacy and poorly documented adverse effects. It is better to continue to use older antidepressants such as tricyclics or serotonin reuptake inhibitors.