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No differences between men and women in adverse drug reactions related to psychotropic drugs: a survey from F rance, I taly and S pain
Author(s) -
D'Incau Paola,
LapeyreMestre Maryse,
Carvajal Alfonso,
Donati Monia,
Salado Inés,
Rodriguez Lauriane,
Sáinz María,
Escudero Antonio,
Conforti Anita
Publication year - 2014
Publication title -
fundamental and clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.655
H-Index - 73
eISSN - 1472-8206
pISSN - 0767-3981
DOI - 10.1111/fcp.12032
Subject(s) - medicine , adverse effect , drug , population , seriousness , drug reaction , psychotropic drug , psychiatry , environmental health , political science , law
A large number of studies have suggested that being a woman represents a potential risk factor for the development of adverse drug reactions ( ADR s). The aim of this study is to further explore the differences between men and women with regard to reported ADR s, particularly those associated with psychotropic drugs. We used spontaneous reports of suspected ADR s collected by M idi‐ P yrénées ( F rance), V eneto ( I taly) and C astilla y L eón ( S pain) R egional P harmacovigilance C entres ( J anuary 2007– D ecember 2009). All the reports including a psychotropic medication were selected in a first step; age distribution, seriousness and type of ADR s 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 ADR s in women, ADR reporting rates might be similar as highlighted by the case of antidepressants. Antidepressant ADR s 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.