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

Abstract

Introduction

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.

Aim

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.

Methods

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.

Results

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.

Conclusion

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.

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Correspondence to Cristiano Matos.

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No funding was received for this study

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Carolina Valeiro, Cristiano Matos, Joep Scholl and Florence van Hunsel have no conflicts of interest to declare that are directly relevant to the contents of this study.

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Ethical approval was not needed for this study.

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Availability of data and material

The datasets for this manuscript are not publicly available because of the Lareb data protection policy. Requests to access the datasets should be directed to the first author and will be granted upon reasonable request.

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The SQL statements for the data used in this article are not publicly available because of the Lareb data protection policy. Requests to access the datasets should be directed to the first author and will be granted upon reasonable request.

Author contributions

The original study protocol was designed by all authors. The query and dataset were established by JS, and data analysis was performed by CV and CM. The design of the manuscript was determined by all authors. All authors contributed to the final data analysis and manuscript drafting and revision, read and approved the final version to be published, and agree to be accountable for all aspects of the work.

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Valeiro, C., Matos, C., Scholl, J. et al. Drug-Induced Sexual Dysfunction: An Analysis of Reports to a National Pharmacovigilance Database. Drug Saf 45, 639–650 (2022). https://doi.org/10.1007/s40264-022-01174-3

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