Drug-Induced Sexual Dysfunction: An Analysis of Reports to a National Pharmacovigilance Database.

Abstract

Sexual dysfunction (SD) is a problem that can affect any phase of the sexual response cycle (such as sexual desire, arousal and orgasm) and individuals of any age. SD can be caused by physical reasons, such as medical conditions, alcoholism or drug abuse; psychological factors, such as stress and anxiety; and different medicines, such as selective serotonin reuptake inhibitors (SSRIs), and their associated adverse effects. The aim of this study was to characterise drugs suspected to have caused SD adverse drug reactions (ADRs) in patients, by conducting a descriptive study based on pharmacovigilance reports. Reports submitted to the Netherlands Pharmacovigilance Centre Lareb from January 2003 to December 2019 were used to investigate drug-induced sexual disorders. Selected reports had at least one ADR reported in the Medical Dictionary for Regulatory Activities (MedDRA®) System Organ Class (SOC) 'Reproductive system and breast disorders' and the SOC 'Psychiatric disorders' relating to sexual disorders and corrected for drug utilisation (expenditure) for the Dutch population. A total of 2815 SD ADRs were reported in the observed period. Data were divided according to three variables: pharmacotherapeutic group, the drug itself, and sex. A total of 722 different SD/pharmacotherapeutic group pairs were observed. The pharmacotherapeutic groups with the highest frequency of SD reports were SSRIs (n=488, 17.58%), other antidepressants (n=172, 6.20%) and HMG-CoA reductase inhibitors (n=149, 5.37%). Distinguishing ADRs by sex, men suffered more from erectile dysfunction, decreased libido and ejaculation disorders, while among women, libido disorders, dyspareunia and SD were the most common ADRs. Different reactions and disproportionality of reactions were detected between the sexes. Antidepressants, antihypertensives, oral contraceptives, α-blockers, and anti-androgens were the pharmacotherapeutic groups with the highest number of SD reports and corresponding high odds ratios.