Patient reporting of sexual adverse events on an online platform for medication experiences

Abstract

Aims: For >300 drugs, sexual side effects are included in the drug information leaflet. As sexual adverse events (sAEs) may be more easily shared at online medication platforms, patient-reported drug experiences may add to the current knowledge on sAE experiences. This study evaluated patient reports from the online platform mijnmedicijn.nl for the frequency of sAE reporting, sex differences concerning sAEs and to assess drugs with disproportional sAE reporting.

Methods: On the online platform, terms for sAEs as used by patients were collected with a poll. Subsequently, drug reports posted between 2008 and 2020 were searched for sAEs with the identified terms. From the retrieved reports, the sAE frequencies and complaints and reporting odds ratios (ROR) were calculated, stratified for sex and drug (class). sAE reporting was considered disproportional frequent if the lower 95% confidence interval bound of the ROR >2.0.

Results: For 189 drugs, sAEs were identified in 2408 reports (3.9%). Women posted 1383 reports (3.5% of all female reports) and men 1025 (4.7%). Almost half of the sAE reports addressed antidepressants: 586 reports of women (ROR 4.2; 95%CI 3.8-4.7) and 510 reports of men (ROR 7.5; 95%CI 6.6-8.5). Disproportional high numbers of sAE reports were found for 27 drugs, mostly antidepressants, hormonal contraceptives and drugs used in benign prostatic hyperplasia. Of these drugs with frequent sAEs, 7 had low sAE risks in their professional drug information.

Conclusion: One in 25 drug reports on mijnmedicijn.nl included sAEs. The sAEs were reported frequently for antidepressants, contraceptives and drugs used in benign prostatic hyperplasia.

Keywords: patient-reported outcome measures-sex differences; pharmacovigilance; sexual adverse events; sexual dysfunction-adverse drug reaction reporting.