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Medications mostly associated with priapism events: assessment of the 2015–2020 Food and Drug Administration (FDA) pharmacovigilance database entries

Abstract

A range of drugs have a direct role in triggering ischaemic priapism. We aimed at identifying: a) which medications are associated with most priapism-reports; and, b) within these medications, comparing their potential to elicit priapism through a disproportionality analysis. The FDA Adverse Event Reporting System (FAERS) database was queried to identify those drugs associated the most with priapism reports over the last 5 years. Only those drugs being associated with a minimum of 30 priapism reports were considered. The Proportional Reporting Ratios (PRRs), and their 95% confidence intervals were computed. Out of the whole 2015–2020 database, 1233 priapism reports were identified, 933 of which (75.7%) were associated with 11 medications with a minimum of 30 priapism-reports each. Trazodone, olanzapine and tadalafil showed levels of disproportionate reporting, with a PRR of 9.04 (CI95%: 7.73–10.58), 1.55 (CI95%: 1.27–1.89), and 1.42 (CI95%: 1.10–1.43), respectively. Most (57.5%) of the reports associated with the phosphodiesterase type 5 inhibitors (PDE5Is) were related with concomitant priapism-eliciting drugs taken at the same time and/or inappropriate intake/excessive dosage. Patients taking trazodone and/or antipsychotics need to be aware of the priapism-risk; awareness among prescribers would help in reducing priapism-related detrimental sequelae; PDE5I-intake is not responsible for priapism by itself, when appropriate medical supervision is provided.

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Data availability

The datasets generated during the current study are available in the FDA Adverse Event Reporting System (FAERS) Public Dashboard repository, https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard

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Acknowledgements

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

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Conception of the work: NS and FS; Data collection: NS, GF and OC; Data analysis and interpretation: NS, PC, LB, FC, HA, AM, FD, FM, FS and AS; Drafting the article: NS and FS; Critical revision of the article: PC, LB, GF, OC, FC, HA, AM, FD, FS, FM and AS; Final approval of the version to be published: NS, PC, LB, GF, OC, FC, HA, AM, FD, FS, FM and AS.

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Correspondence to Andrea Salonia.

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Schifano, N., Capogrosso, P., Boeri, L. et al. Medications mostly associated with priapism events: assessment of the 2015–2020 Food and Drug Administration (FDA) pharmacovigilance database entries. Int J Impot Res (2022). https://doi.org/10.1038/s41443-022-00583-3

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  • DOI: https://doi.org/10.1038/s41443-022-00583-3

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