title: No differences between men and women in adverse drug reactions related to psychotropic drugs: a survey from France, Italy and Spain.
abstract: A large number of studies have suggested that being a woman represents a potential risk factor for the development of adverse drug reactions (ADRs). The aim of this study is to further explore the differences between men and women with regard to reported ADRs, particularly those associated with psychotropic drugs. We used spontaneous reports of suspected ADRs collected by Midi-Pyrénées (France), Veneto (Italy) and Castilla y León (Spain) Regional Pharmacovigilance Centres (January 2007-December 2009). All the reports including a psychotropic medication were selected in a first step; age distribution, seriousness and type of ADRs were compared between men and women. Reports of nonpsychotropic drugs were similarly identified and treated. The absolute number of reports and the proportion, considering population, were higher in women than in men. This was observed for all reports, but was particularly higher for psychotropic drugs (592 vs. 375; P < 0.001) than for nonpsychotropics drugs (5193 vs. 4035; P < 0.001). Antidepressants were the most reported (women, 303; men, 141; P < 0.001); the reporting rates (number of reports divided by exposed patients in the same period, estimated through sales data) for these drugs, however, were not significantly different between women (0.87 cases per 10 000 treated persons per year) and men (0.81 cases per 10 000 treated persons per year). Although there was a higher number of reports of ADRs in women, ADR reporting rates might be similar as highlighted by the case of antidepressants. Antidepressant ADRs in fact were similarly reported in men and in women. Gender differences are sometimes subtle and difficult to explore. International networks, as the one established for this study, do contribute to better analyse problems associated with medications.
authors.affiliation: Dipartimento di Sanità Pubblica e Medicina di Comunità, Sezione di Farmacologia, Università di Verona, Verona, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: D'Incau
authors.forename: Maryse
authors.initials: M
authors.lastname: Lapeyre-Mestre
authors.forename: Alfonso
authors.initials: A
authors.lastname: Carvajal
authors.forename: Monia
authors.initials: M
authors.lastname: Donati
authors.forename: Inés
authors.initials: I
authors.lastname: Salado
authors.forename: Lauriane
authors.initials: L
authors.lastname: Rodriguez
authors.forename: María
authors.initials: M
authors.lastname: Sáinz
authors.forename: Antonio
authors.initials: A
authors.lastname: Escudero
authors.forename: Anita
authors.initials: A
authors.lastname: Conforti
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D016009:Chi-Square Distribution; D003627:Data Interpretation, Statistical; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000209:etiology; D005602:France / Q000453:epidemiology; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008297:Male; D011619:Psychotropic Drugs / Q000009:adverse effects*; D012727:Sex Characteristics; D013030:Spain / Q000453:epidemiology
chemical_list: D011619:Psychotropic Drugs
keywords: gender; pharmacovigilance; psychotropics; reporting