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.
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(1) New marketing authorizations continue to be granted for treatments of multiple myeloma, and new trials and meta-analyses continue to be published. This review re-examines our previous conclusions based on data published between 2003 and 2008. We again used the standard Prescrire methodology to review the latest data; (2) In patients who are symptomatic but who do not qualify for haematopoietic stem cell transplantation (especially people aged over 65), the results of five comparative trials suggest that adding thalidomide to the melphalan-prednisone combination delays myeloma progression by an additional 5 to 10 months. ⋯ Initial treatment with two successive transplantation procedures has a negative risk-benefit balance. (4) The optimal chemotherapy regimen prior to autologous stem cell transplantation is controversial. It is unclear which combination (vincristine + doxorubicin + dexamethasone, cyclophosphamide + dexamethasone, cyclophosphamide + dexamethasone, or bortezomib + dexamethasone, etc.) has a better risk-benefit balance in terms of survival and quality of life; (5) According to a meta-analysis of three clinical trials, thalidomide maintenance therapy appears to improve overall survival after Autologous stem cell transplantation; (6) Despite their inadequate evaluation, lenalidomide and pegylated liposomal doxorubicin are licensed for use in patients who relapse or who are refractory to initial treatment. In view of their major adverse effects, we consider that these drugs should only be used in clinical trials.