MP36-11 ADVERSE EVENTS ASSOCIATED WITH PHOSPHODIESTERASE-5 INHIBITORS AS REPORTED IN A FOOD AND DRUG ADMINISTRATION DATABASE: REVIEWING 15 YEARS OF DATA

Abstract

You have accessJournal of UrologySexual Function/Dysfunction: Medical, Hormonal & Non-surgical Therapy II (MP36)1 Sep 2021MP36-11 ADVERSE EVENTS ASSOCIATED WITH PHOSPHODIESTERASE-5 INHIBITORS AS REPORTED IN A FOOD AND DRUG ADMINISTRATION DATABASE: REVIEWING 15 YEARS OF DATA Joshua Cadwell, Salma Ahsanuddin, Mutahar Ahmed, Mohammad Nawaz, and Mubashir Billah Joshua CadwellJoshua Cadwell More articles by this author , Salma AhsanuddinSalma Ahsanuddin More articles by this author , Mutahar AhmedMutahar Ahmed More articles by this author , Mohammad NawazMohammad Nawaz More articles by this author , and Mubashir BillahMubashir Billah More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002045.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Erectile dysfunction (ED) is a prevalent condition in aging men. Initial medical therapy includes the use of phosphodiesterase-5 (PDE-5) inhibitors including vardenafil, avanafil, sildenafil, and tadalafil. However, few studies have discussed the prevalence of adverse events (AEs) across a large patient population. Our objective is to review the Food and Drug Administration’s Adverse Event Reporting System (FAERS) database and identify the most common adverse events associated with PDE-5 inhibitors. METHODS: The FAERS database was queried for the most frequently reported AEs across four common PDE-5 inhibitors. The Reporting Odds Ratio (ROR) was then calculated for the most common AEs across these four medications in order to distinguish AEs with a disproportionately high level of reporting as compared to all other drugs in the database. The ROR was considered a positive signal if the lower limit of the 95% confidence interval exceeded 1. RESULTS: A median of n=16,764 (3,653-77,084) AEs were reported for each drug. Statistical analysis revealed headache, dizziness, and ineffectiveness among the most frequent AEs. Drug ineffectiveness was the most common AE reported in nearly all PDE-5 inhibitors but only had positive signals in avanafil and vardenafil. Malignant melanoma was also a reported AE with positive signals in vardenafil and avanafil. Headache had a positive signal in all studied drugs except avanafil. Tadalafil alone was associated with a positive signal for dizziness. CONCLUSIONS: PDE-5 inhibitors are widely prescribed drugs for the treatment of erective dysfunction but their AE profile is often overlooked. Headaches are a known side effect of this class of medications, a finding that is confirmed with a positive signal across almost all studied drugs. More concerning positive signals include malignant melanoma, an AE that has been previously reported in the literature and requires further evaluation. The FAERS database is useful to identify possible AEs but it cannot be used to determine causality. Source of Funding: Not applicable © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e639-e640 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Joshua Cadwell More articles by this author Salma Ahsanuddin More articles by this author Mutahar Ahmed More articles by this author Mohammad Nawaz More articles by this author Mubashir Billah More articles by this author Expand All Advertisement Loading ...