You have accessJournal of UrologyCME1 May 2022MP07-13 MEDICATIONS MOSTLY ASSOCIATED WITH HAEMATURIA: ASSESSMENT OF THE EUDRAVIGILANCE (EV) AND FOOD AND DRUG ADMINISTRATION (FDA) PHARMACOVIGILANCE DATABASES ENTRIES Lorenzo Maria Rovesti, Antonio Nacchia, Ferdinando Di Giacomo, Giuseppe Disabato, Carmen Gravina, Giacomo Gallo, Jordi Stira, Beatrice Turchi, Alessandro Guercio, Riccardo Lombardo, Antonio Cicione, Olivia Alessandra Voglino, Valeria Baldassarri, Giorgio Guarnotta, Elisa Mancini, Antonio Franco, Simone D'Annunzio, Andrea Tubaro, and Cosimo De Nunzio Lorenzo Maria RovestiLorenzo Maria Rovesti More articles by this author , Antonio NacchiaAntonio Nacchia More articles by this author , Ferdinando Di GiacomoFerdinando Di Giacomo More articles by this author , Giuseppe DisabatoGiuseppe Disabato More articles by this author , Carmen GravinaCarmen Gravina More articles by this author , Giacomo GalloGiacomo Gallo More articles by this author , Jordi StiraJordi Stira More articles by this author , Beatrice TurchiBeatrice Turchi More articles by this author , Alessandro GuercioAlessandro Guercio More articles by this author , Riccardo LombardoRiccardo Lombardo More articles by this author , Antonio CicioneAntonio Cicione More articles by this author , Olivia Alessandra VoglinoOlivia Alessandra Voglino More articles by this author , Valeria BaldassarriValeria Baldassarri More articles by this author , Giorgio GuarnottaGiorgio Guarnotta More articles by this author , Elisa ManciniElisa Mancini More articles by this author , Antonio FrancoAntonio Franco More articles by this author , Simone D'AnnunzioSimone D'Annunzio More articles by this author , Andrea TubaroAndrea Tubaro More articles by this author , and Cosimo De NunzioCosimo De Nunzio More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002529.13AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Drugs may have a direct causative role in triggering haematuria. The range of medications which may be responsible for haematuria is wide but little is known on those which are most frequently involved. We aimed at identifying 1) which medications are associated with most haematuria reports; 2) within the high-risk list of medications, comparing their potential to cause haematuria 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 haematuria individual reports till 30 June 2021 (Table). Only those drugs with a minimum of 400 haematuria reports were here considered for disproportionality analysis. 11 drugs were identified. We recorded the number of haematuria reports for these 11 drugs in EudraVigilance (EV) database. Proportional Reported Ratios (PRRs) were computed for all the drugs individuated in this way. RESULTS: Overall, 36315 haematuria reports were identified, 15319 of which (43%) were associated with those 11 medications which had a minimum of 400 reports each (Table). Within this group of high-risk medications, Rivaroxaban presented higher risk of haematuria. (Table). Most of the reported haematuria for drugs were presented in the 65-85 range of age (37%). Serious cases including death were 32131 (88%). EV database analysis confirmed the highest rate of haematuria reports for Rivaroxaban (5042 events of which 302 serious (6%), with 31 deaths (1%)) within anticoagulants and for Aspirin (2404 events of which 101 serious (4%) with 18 deaths (1%)) within antiplatelets. CONCLUSIONS: 11 drugs were here identified as being associated with significant reporting levels for haematuria. Among them Rivaroxaban was responsible for the most reports as in FDA FAERS database as in EV database and generated the strongest signal of disproportionate reporting. Prescribers should inform those treated with these medications about the risk of haematuria and its sequelae. These results require to be further integrated with clinical evidence. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e120 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Lorenzo Maria Rovesti More articles by this author Antonio Nacchia More articles by this author Ferdinando Di Giacomo More articles by this author Giuseppe Disabato More articles by this author Carmen Gravina More articles by this author Giacomo Gallo More articles by this author Jordi Stira More articles by this author Beatrice Turchi More articles by this author Alessandro Guercio More articles by this author Riccardo Lombardo More articles by this author Antonio Cicione More articles by this author Olivia Alessandra Voglino More articles by this author Valeria Baldassarri More articles by this author Giorgio Guarnotta More articles by this author Elisa Mancini More articles by this author Antonio Franco More articles by this author Simone D'Annunzio More articles by this author Andrea Tubaro More articles by this author Cosimo De Nunzio More articles by this author Expand All Advertisement PDF DownloadLoading ...
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