Gender differences in spontaneously reported possible adverse drug reactions in the Netherlands

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    Gender differences in spontaneously reported possible adverse drug reactions in the Netherlands S.T. de Vries1, P. Denig1, P.G.M. Mol1, E.P. van Puijenbroek2 1Dept. of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands; 2The Netherlands Pharmacovigilance Centre Lareb, den Bosch, The Netherlands. Although females are included in most clinical trials, possible gender differences in adverse drug reactions (ADRs) are not systematically evaluated. A recent study using the FDA Adverse Event Reporting System showed statistically significant gender differences in 307 of the 668 assessed drugs.1 Aims The aim of this study was to assess the extent of possible gender differences in reported drug-possible ADR associations in the Netherlands. Methods We used spontaneously reported possible ADRs to the Netherlands pharmacovigilance centre Lareb in the years 2003–2016. Reports from both healthcare professionals (i.e. general practitioners, pharmacists, medical specialists, and nurses) and consumers were included. Reports were excluded when they concerned vaccines or consumers aged <5 years or with an unknown age. Drugs were assessed on the chemical substance level (fifth level) of the Anatomical Therapeutical Chemical classification system (ATC). Possible ADRs were assessed on the preferred term level of the medical dictionary for regulatory activities (MedDRA®) version 20.0. Drug-possible ADR combinations were included when there were ten or more reports. Logistic regression analyses were conducted to test the association between gender and specific drug-possible ADR combinations. These analyses were corrected for the number of drug users based on data from the Drug Information System of the National Health Care Institute (GIP databank). P-values <0.05 were considered statistically significant. Results In total, gender differences were tested for 2,765 user-adjusted drug-possible ADR combinations. A statistically significant gender difference was shown in 373 combinations (13%). In most cases, females had a higher odds for a specific drug-possible ADR combination than males (326 versus 47 combinations). Drug classes with many significant gender differences in drug-possible ADR combinations included thyroid hormones (H03AA: 32 combinations, all with higher odds for females), HMG-CoA-reductase inhibitors (C10AA: 20 combinations with higher odds for females and 5 for males), and selective serotonin reuptake inhibitors (N06AB: 13 combinations with higher odds for females and 11 for males). Nausea, alopecia, and headache were the most common possible ADRs that had higher odds for females (in respectively 32, 29, and 21 combinations). Aggression, death, dizziness, pyrexia, sexual dysfunction, tendon rupture, and tinnitus were the most common possible ADRs with higher odds for males (all in 2 drug-possible ADR combinations). Conclusions This study identified a list with gender differences in drug-possible ADR combinations. Further studies are needed to assess underlying reasons for gender differences in specific drug-possible ADR combinations, including pharmacological and behavioral factors. The results may ultimately lead to gender-specific prescribing recommendations. References: 1. Yu Y, et al. Systematic analysis of adverse event reports for sex differences in adverse drug events. Sci Rep 2016;6:24955.
    Originele taal-2English
    StatusUnpublished - 3-okt-2017
    EvenementFIGON Dutch Medicines Days - Ede, Netherlands
    Duur: 2-okt-20173-okt-2017

    Conference

    ConferenceFIGON Dutch Medicines Days
    Land/RegioNetherlands
    StadEde
    Periode02/10/201703/10/2017

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