Mp34-14 medications mostly associated with urinary tract infections (utis): assessment of the eudravigilance (ev) and food and drug administration (fda) pharmacovigilance databases entries

You have accessJournal of UrologyCME1 Apr 2023MP34-14 MEDICATIONS MOSTLY ASSOCIATED WITH URINARY TRACT INFECTIONS (UTIS): ASSESSMENT OF THE EUDRAVIGILANCE (EV) AND FOOD AND DRUG ADMINISTRATION (FDA) PHARMACOVIGILANCE DATABASES ENTRIES Cosimo De Nunzio, Riccardo Lombardo, Antonio Nacchia, Antonio Cicione, Carmen Gravina, Beatrice Turchi, Giacomo Gallo, Jordi Stira, Antonio Franco, Lorenzo Maria Rovesti, Sara Riolo, Giorgio Guarnotta, Elisa Mancini, Antonio Luigi Pastore, Antonio Carbone, Andrea Fuschi, Alessandro Sciarra, Costantino Leonardo, Francesco Del Giudice, Stefano Salciccia, Giorgio Franco, Andrea Tubaro, Ferdinando Di Giacomo, and Giuseppe Disabato Cosimo De NunzioCosimo De Nunzio More articles by this author , Riccardo LombardoRiccardo Lombardo More articles by this author , Antonio NacchiaAntonio Nacchia More articles by this author , Antonio CicioneAntonio Cicione More articles by this author , Carmen GravinaCarmen Gravina More articles by this author , Beatrice TurchiBeatrice Turchi More articles by this author , Giacomo GalloGiacomo Gallo More articles by this author , Jordi StiraJordi Stira More articles by this author , Antonio FrancoAntonio Franco More articles by this author , Lorenzo Maria RovestiLorenzo Maria Rovesti More articles by this author , Sara RioloSara Riolo More articles by this author , Giorgio GuarnottaGiorgio Guarnotta More articles by this author , Elisa ManciniElisa Mancini More articles by this author , Antonio Luigi PastoreAntonio Luigi Pastore More articles by this author , Antonio CarboneAntonio Carbone More articles by this author , Andrea FuschiAndrea Fuschi More articles by this author , Alessandro SciarraAlessandro Sciarra More articles by this author , Costantino LeonardoCostantino Leonardo More articles by this author , Francesco Del GiudiceFrancesco Del Giudice More articles by this author , Stefano SalcicciaStefano Salciccia More articles by this author , Giorgio FrancoGiorgio Franco More articles by this author , Andrea TubaroAndrea Tubaro More articles by this author , Ferdinando Di GiacomoFerdinando Di Giacomo More articles by this author , and Giuseppe DisabatoGiuseppe Disabato More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003268.14AboutAbstractPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail Abstract INTRODUCTION AND OBJECTIVE: Drugs may have a direct causative role in triggering urinary tract infections (UTIs). The range of medications which may be responsible for UTIs is wide but little is known on those which are most frequently involved. We aimed at identifying: 1) which medications are associated with most UTIs reports; 2) within the high-risk list of medications, comparing their potential to cause UTIs through a disproportionality analysis. METHODS: The Food and Drug Administration Adverse Event Reporting System (FDA-FAERS) database was queried to identify the drugs which were mostly associated with UTIs (bacterial, escherichia, staphylococcal, pseudomonal, enterococcal) reported from 10th September 2012 to 30th June 2021. Only those drugs with a minimum of 200 UTIs reports were considered for disproportionality analysis. We recorded the number of UTIs reports for such drugs reported into the Eudra-Vigilance (EV) database. EV is the system for managing and analyzing information on suspected adverse reactions to medicines which have been authorized or being studied in clinical trials in the European Economic Area (EEA). Proportional Reported Ratios (PRRs) were computed for all the drugs individuated in this way. RESULTS: Overall, 6152 UTIs reports were identified. 1798 of them (30%) were associated with six medications which individually had a minimum of 200 reports (Table 1). Within this group of high-risk medications, Tacrolimus presented higher risk of UTIs as than prednsione (PRR 1.48 (95% CI 1.29-1.71) p<0.01) and than adalimumab (PRR 1.71 (95% CI 1.48-1.99), p<0.01). No significative differences were reported between prednisone and adalimumab (PRR 1.15 (95% CI 0.98-1.36), p=0.07) (Table 1). Most of the reported UTIs for drugs were presented in the 18-64 range of age (43%). Serious cases including death were 5902 (96%). On EV database analysis most UTIs reports were for Natalizumab (1433 events). Most reports for Escherichia UTIs were for Tacrolimus and Mycophenolate Mofetil, both with 78 events. Most reports for Enterococcal UTIs were for Natalizumab with 18 events. Most reports for Pseudomonal, Enterococcal and Staphylococcal UTIs were for Natalizumab respectively with 22, 18 and 11 events. Table 1: PRR for urinary tract infections according to immunosuppressors Data are reported as PRR (95%CI), *Statistically significant PRR CONCLUSIONS: Six drugs were here identified as being associated with significant reporting levels of UTIs. Among them Tacrolimus and Natalizumab were responsible for the most reports respectively in FDA-FAERS database and in EV database and generated the strongest signal of disproportionate reporting. Our analysis highlighted similarities and differences between the two databases. Prescribers should inform those treated with these immunosuppressors about the risk of infections and its sequelae. These results require to be further integrated with clinical evidence. Header Tacrolimus Prednisone Adalimumab Mycophenolate mofetil Natalizumab Dalfampridine Tacrolimus 1,48* 1,71* 1,77* 2,05* 2,09* Prednisone 0,67* 1,15* 1,19* 1,37* 1,40* Adalimumab 0,58* 0,86* 1,03* 1,19* 1,21* Mycophenolate mofetil 0,56* 0,83* 0,97 2,04* 2,08* Natalizumab 0,49* 0,72* 0,84* 0,86 1,02 Dalfampridine 0,48* 0,71* 0,82* 0,85* 0,98 Data are reported as PRR (95%CI), *Statistically significant PRR. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e464 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Cosimo De Nunzio More articles by this author Riccardo Lombardo More articles by this author Antonio Nacchia More articles by this author Antonio Cicione More articles by this author Carmen Gravina More articles by this author Beatrice Turchi More articles by this author Giacomo Gallo More articles by this author Jordi Stira More articles by this author Antonio Franco More articles by this author Lorenzo Maria Rovesti More articles by this author Sara Riolo More articles by this author Giorgio Guarnotta More articles by this author Elisa Mancini More articles by this author Antonio Luigi Pastore More articles by this author Antonio Carbone More articles by this author Andrea Fuschi More articles by this author Alessandro Sciarra More articles by this author Costantino Leonardo More articles by this author Francesco Del Giudice More articles by this author Stefano Salciccia More articles by this author Giorgio Franco More articles by this author Andrea Tubaro More articles by this author Ferdinando Di Giacomo More articles by this author Giuseppe Disabato More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...