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-Pyr en ees (France), Veneto (Italy) and Castilla y Le on (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.

Influence of age, sex and seriousness on reporting of adverse drug reactions in Sweden

“…28 We cannot provide any clear explanation for our noted sex differences in the reporting of ICSRs, which previously has been deemed as difficult to assess. 31 However, our finding of higher RR for serious ICSRs in men than in women is difficult to comprehend, especially when some studies imply that ADRs are more common in women. [8][9][10] The inevitable question arises: are reporters more likely to report serious ADRs for men compared to women?…”

“…20,[28][29][30] Stratification for seriousness is only performed in one of them. 30 Others have studied these issues based on a sample of selected drugs 19,31,32 or based on regional data. 16 None of them have investigated the impact of sex-dependent drugs.…”

“…A consistent comparison of our results with these studies is complicated by the nature of the different types of denominator used for calculating RR. Other used denominators, besides numbers of DDD, 22,31,32 are numbers of inhabitants, 14,16 prescriptions, 19,30 exposed patients 32 or number of drugs. 19 We used DDD as denominator which we judge to be the most appropriate proxy for overall drug exposure.…”

Trends in adverse drug reaction‐related hospitalisations over 13 years in New South Wales, Australia

“…conducted a prospective multicentre study and showed that females experienced 60% excess risk of ADR compared to males. However, the lack of a statistically significant difference was reported in the survey conducted in France, Italy and Spain . In 2015, Yu et al .…”

“…However, the lack of a statistically significant difference was reported in the survey conducted in France, Italy and Spain. 36 In 2015, Yu et al 37 conducted a systematic review to investigate variation of ADR in different genders across different medications and indicated the existence of gender differences in biological reactions to medication. This study also found ADR variation by gender across different medication agents, which more or less reflects gender differences in use or reaction pattern.…”