Sexual Disorders with Selective Serotonin Reuptake Inhibitors: A Comparative Study

Introduction: Sexual dysfunction may be a symptom of major depression. Moreover, sexual disorders occurring in association with selective serotonin reuptake inhibitors (SSRIs) therapy is well-known but underreported. In pharmacovigilance, the phenomenon of underreporting is known, but reporting rates depend amongst other things, on the frequency with which adverse drug reactions (ADRs) occur. Objective: The aim of this study was to determine and compare the reporting rate of sexual disorders in association with SSRIs. Methods: The data were extracted from the WHO pharmacovigilance database, Vigibase, from 1967 to December 2021. Sexual disorders were identified and extracted from the database using the standardized MedDRA Query (SMQ) "sexual dysfunction". First of all, we analyzed data. We calculated the rate of reported sexual disorders as a percentage of the total adverse drug reactions (ADRs) for each drug. We performed a disproportionality analysis through the calculation of reporting odds ratio (ROR) with 95% confidence intervals (CIs). Results: A total of 337 832 ADRs with the SMQ sexual dysfunction were reported during the period of which 12 963 with SSRIs. The medication with the most frequently ADRs were paroxetine (n = 3937), sertraline (n = 3418) and fluoxetine (n = 2763). The most frequently ADRs reported were libido decreased and erectile dysfunction. The physicians reported only 25% of cases. All the SSRIs have a ROR statistically significant. The highest ROR were observed with paroxetine (ROR 4.00, 95% CI 3.88-4.13), sertraline (ROR 3.27, 95% CI 3.16-3.38) and escitalopram (ROR 2.86, 95% CI 2.71-3.02). Conclusion: Sexual disorders occurring with SSRIs therapy are known but underestimated. Sexual side effect have sexual, psychological and social consequences. Physicians must report this type of ADR and improve the clinical management.