Gender differences of ADRs related to psychotropic drug: a survey from Italy, France and Spain
Year: 2011
Type: dissertation
Study design: Observational Study
Abstract: Background: It is well recognized that being female appears to be a risk factor for developing ADRs. A number of studies clearly suggest that ADRs are 50% to 75% more likely in women than in men. It has also been suggested that there is a female preponderance in the number of ADRs experienced with nervous system agents. Results from the European Study of the Epidemiology of Mental disorders (ESEMED) conducted in 2001-2003, highlight that the use of psychotropic drugs was more prevalent among women than men. Anxiolytics, sedatives and hypnotics were more often used, followed by antidepressants and antipsychotics. A female propensity to experience of drug adverse effects may result from “gender” related differences in drug exposure as well as “sex” related differences in drug pharmacokinetics and pharmacodynamics. Nonetheless, the reasons for this increased risk in female patients are not entirely clear, notably whether adverse drug reactions among women reflect an inappropriate use of psychotropic medications. Objective: The aim of this study is to analyze the difference between women and men of psychotropic drugs ADRs reported in the regional pharmacovigilance centre of Midi-Pyrénées (France), Veneto (Italy) and Castilla-Leon (Spain) using spontaneously reported reactions. Specifically the spontaneous reports of ADRs studied regarded antipsychotics, anxiolytics, hypnotics, antidepressant and stimulants that were reported between 2007 and 2009. Methods: Within the French, Italian and Spanish Pharmacovigilance System databases, the case/non-case method was used to measure the association with the exposure of psychotropic medications of interest and gender. Cases were the reports corresponding to the ADRs related at least to one type of psychotropic drugs of interest and the non-cases are all reports of ADRs other than that being studied. The association was estimated by calculating a reporting odds ratio (ROR) with its 95% confidence interval (CI). Results: A total of 967 patients were included in the study, 592 (61%) were female and 375 (39%) were male (p< 0,001). Mean age of the study population was 51 years (range 08-97 years). The association between the use of psychotropic medications of interest and gender was statistically significant for women taking antidepressants (ROR crude =1.67; 95% CI 1,35-2,06; ROR stratified for seriousness =1,71; 95% CI 1,39-2,11; ROR stratified for age = 1,53; 95% CI 1,24- 1,90; ROR stratified for age and seriousness =1.54; 95% CI 1,25-1,90) [all p < 0,001]. Analyzing all reports of ADRs reported, the most involved drugs were risperidone (14 % of the total N05A drugs), alprazolam (14 % of the total N05B drugs), zolpidem (32% of the total N05C drugs), paroxetine (16 % of the total N06A drugs) and methylphenidate (39% of the total N06B drugs), while the most associated with sex, in particular with female sex, were lithium carbonate (p<0.05) and prazepam (p<0.05), and with male sex were clozapine (p<0.05) and sertraline (p<0.05). The most frequent type of ADRs reported in all women reports were classified as “Central & peripherical nervous system disorders” (24%) and “Psychiatric disorders” (18%), while in all men reports were “Body as a whole - general disorders” (14%) and “Resistance mechanism disorders” (13%). Conclusions: The present study which investigated the role of gender in ADRs reported to a regional French, Italian and Spain Pharmacovigilance centres indicates that female sex is a risk factor for the development of ADRs related to psychotropic drugs especially to antidepressants. Further research should be performed to investigate the sex-specific drug safety of psychtropic use, taking into account potential risk factors, not only in relation to pharmacogenetics, pharmacokinetics and pharmacodynamics, but also in psychological, social, economic, political and cultural aspects.
Author: Paola D’Incau
Language: English
Subfield: Toxicology
Domain: Life Sciences
Open Access status: green
OpenAlex ID: W68341129