TY - JOUR
T1 - Drug-induced Urinary Retention
T2 - An Analysis of a National Spontaneous Adverse Drug Reaction Reporting Database
AU - Crisafulli, Salvatore
AU - Cutroneo, Paola Maria
AU - Verhamme, Katia
AU - Ferrajolo, Carmen
AU - Ficarra, Vincenzo
AU - Sottosanti, Laura
AU - Di Giovanni, Valentina
AU - Spina, Edoardo
AU - Trifirò, Gianluca
N1 - Publisher Copyright: © 2021 European Association of Urology
PY - 2022/9
Y1 - 2022/9
N2 - Background: Numerous drugs have been associated with urinary retention (UR), but updated information on drugs that may induce UR is limited. Objective: To evaluate drug-induced UR using the Italian spontaneous adverse drug reactions (ADRs) reporting database. Design, setting, and participants: We selected all suspected spontaneous reports of drug-induced UR collected into the Italian spontaneous reporting system (SRS) database from its inception to June 30, 2019. Outcome measurements and statistical analysis: The Mantel-Haenszel χ2 test and the Mann-Whitney U test were performed for statistical comparisons of categorical and continuous variables, respectively. As a measure of disproportionality, we calculated the reporting odds ratios (RORs) with corresponding 95% confidence intervals using a statistical case/noncase methodology. Results and limitations: A total of 506 383 ADR reports were received in the Italian SRS database during the study period. Of these, 421 reports (0.1%) included UR-related ADRs, for a total of 497 suspected drugs. The median (interquartile range [IQR]) age of patients experiencing UR was 67 (47–77) yr. Overall, 174 (41.3%) ADR reports were considered serious. One-third of male patients experiencing UR suffered from benign prostatic hyperplasia, followed by diabetes mellitus (N = 58, 13.8%), and bladder-related disorders (N = 21, 5.0%). The median lag time between the start of drug treatment and UR onset was 7 (IQR 1–47.5) d. Overall, a statistically significant ROR was reported for 39 individual drugs, and for five (12.8%) of them (dapagliflozin, gabapentin, lithium, celecoxib, and piroxicam) UR was not described in their summary of product characteristics. Limitations include under-reporting and selective over-reporting of suspected ADRs and lacking information on the number of drug users. Conclusions: A disproportionality analysis identified five potentially new UR signals for dapagliflozin, gabapentin, lithium, celecoxib, and piroxicam, requiring further evaluation. Patient summary: In this analysis of the Italian spontaneous reporting system database, we found new urinary retention signals, requiring further evaluation, for dapagliflozin, gabapentin, lithium, celecoxib, and piroxicam.
AB - Background: Numerous drugs have been associated with urinary retention (UR), but updated information on drugs that may induce UR is limited. Objective: To evaluate drug-induced UR using the Italian spontaneous adverse drug reactions (ADRs) reporting database. Design, setting, and participants: We selected all suspected spontaneous reports of drug-induced UR collected into the Italian spontaneous reporting system (SRS) database from its inception to June 30, 2019. Outcome measurements and statistical analysis: The Mantel-Haenszel χ2 test and the Mann-Whitney U test were performed for statistical comparisons of categorical and continuous variables, respectively. As a measure of disproportionality, we calculated the reporting odds ratios (RORs) with corresponding 95% confidence intervals using a statistical case/noncase methodology. Results and limitations: A total of 506 383 ADR reports were received in the Italian SRS database during the study period. Of these, 421 reports (0.1%) included UR-related ADRs, for a total of 497 suspected drugs. The median (interquartile range [IQR]) age of patients experiencing UR was 67 (47–77) yr. Overall, 174 (41.3%) ADR reports were considered serious. One-third of male patients experiencing UR suffered from benign prostatic hyperplasia, followed by diabetes mellitus (N = 58, 13.8%), and bladder-related disorders (N = 21, 5.0%). The median lag time between the start of drug treatment and UR onset was 7 (IQR 1–47.5) d. Overall, a statistically significant ROR was reported for 39 individual drugs, and for five (12.8%) of them (dapagliflozin, gabapentin, lithium, celecoxib, and piroxicam) UR was not described in their summary of product characteristics. Limitations include under-reporting and selective over-reporting of suspected ADRs and lacking information on the number of drug users. Conclusions: A disproportionality analysis identified five potentially new UR signals for dapagliflozin, gabapentin, lithium, celecoxib, and piroxicam, requiring further evaluation. Patient summary: In this analysis of the Italian spontaneous reporting system database, we found new urinary retention signals, requiring further evaluation, for dapagliflozin, gabapentin, lithium, celecoxib, and piroxicam.
UR - http://www.scopus.com/inward/record.url?scp=85110511659&partnerID=8YFLogxK
U2 - 10.1016/j.euf.2021.07.001
DO - 10.1016/j.euf.2021.07.001
M3 - Article
C2 - 34275763
AN - SCOPUS:85110511659
SN - 2405-4569
VL - 8
SP - 1424
EP - 1432
JO - European Urology Focus
JF - European Urology Focus
IS - 5
ER -
