PD30-08 MEDICATIONS MOSTLY ASSOCIATED WITH PRIAPISM EVENTS: ASSESSMENT OF THE 2015-2020 FOOD AND DRUG ADMINISTRATION (FDA) PHARMACOVIGILANCE DATABASE ENTRIES

Abstract

You have accessJournal of UrologySexual Function/Dysfunction: Evaluation II (PD30)1 Sep 2021PD30-08 MEDICATIONS MOSTLY ASSOCIATED WITH PRIAPISM EVENTS: ASSESSMENT OF THE 2015-2020 FOOD AND DRUG ADMINISTRATION (FDA) PHARMACOVIGILANCE DATABASE ENTRIES Nicolo' Schifano, Paolo Capogrosso, Luca Boeri, Stefania Chiappini, Edoardo Pozzi, Federico Belladelli, Omer Onur Cakir, Matthew Rewhorn, Fabio Castiglione, Hussain M Alnajjar, Asif Muneer, Federico Deho', Fabrizio Schifano, Francesco Montorsi, and Andrea Salonia Nicolo' SchifanoNicolo' Schifano More articles by this author , Paolo CapogrossoPaolo Capogrosso More articles by this author , Luca BoeriLuca Boeri More articles by this author , Stefania ChiappiniStefania Chiappini More articles by this author , Edoardo PozziEdoardo Pozzi More articles by this author , Federico BelladelliFederico Belladelli More articles by this author , Omer Onur CakirOmer Onur Cakir More articles by this author , Matthew RewhornMatthew Rewhorn More articles by this author , Fabio CastiglioneFabio Castiglione More articles by this author , Hussain M AlnajjarHussain M Alnajjar More articles by this author , Asif MuneerAsif Muneer More articles by this author , Federico Deho'Federico Deho' More articles by this author , Fabrizio SchifanoFabrizio Schifano More articles by this author , Francesco MontorsiFrancesco Montorsi More articles by this author , and Andrea SaloniaAndrea Salonia More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002031.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Drugs may have a direct causative role in triggering ischaemic priapism events. The range of medications which may be responsible for priapism is wide, but little is known on those which are more frequently involved. We aimed at identifying: a) which medications are associated with most priapism reports; and, b) within this high-risk list of medications, comparing their potential to cause priapism through a disproportionality analysis. METHODS: The Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database was queried to identify the drugs which were associated the most with priapism individual reports over the last 5 years (Table 1). Only those drugs being associated with a minimum of 30 priapism reports were here considered for the disproportionality analysis. Proportional Reporting Ratios (PRRs) were computed for all the drugs identified in this way. RESULTS: Out of the whole 2015-2020 database, 1908 priapism reports were identified, 933 of which (48.9%) were associated with those 11 medications which had a minimum of 30 reports each (Table 1). Within this group of high-risk medications, trazodone, olanzapine and tadalafil showed significant levels for actual 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. Quetiapine, risperidone and aripiprazole priapism reports were here well represented as well. CONCLUSIONS: Eleven drugs were here identified as being associated with significant reporting levels of priapism. Among them, trazodone was responsible for most reports and generated the strongest signal of disproportionate reporting. With respect to the remaining 8 drugs, olanzapine and tadalafil seemed to be more prone to cause priapism. Prescribers should inform those treated with these medications about the risk of priapism and its sequelae. These results require to be further integrated with clinical evidence. Source of Funding: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e535-e535 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Nicolo' Schifano More articles by this author Paolo Capogrosso More articles by this author Luca Boeri More articles by this author Stefania Chiappini More articles by this author Edoardo Pozzi More articles by this author Federico Belladelli More articles by this author Omer Onur Cakir More articles by this author Matthew Rewhorn More articles by this author Fabio Castiglione More articles by this author Hussain M Alnajjar More articles by this author Asif Muneer More articles by this author Federico Deho' More articles by this author Fabrizio Schifano More articles by this author Francesco Montorsi More articles by this author Andrea Salonia More articles by this author Expand All Advertisement Loading ...