PMID- 34275763
OWN - NLM
STAT- MEDLINE
DCOM- 20221205
LR  - 20221214
IS  - 2405-4569 (Electronic)
IS  - 2405-4569 (Linking)
VI  - 8
IP  - 5
DP  - 2022 Sep
TI  - Drug-induced Urinary Retention: An Analysis of a National Spontaneous Adverse 
      Drug Reaction Reporting Database.
PG  - 1424-1432
LID - S2405-4569(21)00180-2 [pii]
LID - 10.1016/j.euf.2021.07.001 [doi]
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 chi(2) 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.
CI  - Copyright (c) 2021 European Association of Urology. Published by Elsevier B.V. All 
      rights reserved.
FAU - Crisafulli, Salvatore
AU  - Crisafulli S
AD  - Department of Biomedical and Dental Sciences and Morphofunctional Imaging, 
      University of Messina, Messina, Italy.
FAU - Cutroneo, Paola Maria
AU  - Cutroneo PM
AD  - Sicilian Regional Pharmacovigilance Centre, University Hospital of Messina, 
      Messina, Italy.
FAU - Verhamme, Katia
AU  - Verhamme K
AD  - Department of Medical Informatics, Erasmus MC, University Medical Center 
      Rotterdam, Rotterdam, The Netherlands.
FAU - Ferrajolo, Carmen
AU  - Ferrajolo C
AD  - Department of Experimental Medicine, University of Campania "Luigi Vanvitelli", 
      Naples, Italy; Regional Centre for Pharmacovigilance, Campania Region, Naples, 
      Italy.
FAU - Ficarra, Vincenzo
AU  - Ficarra V
AD  - Department of Human and Pediatric Pathology "Gaetano Barresi", Urologic Section, 
      University of Messina, Messina, Italy.
FAU - Sottosanti, Laura
AU  - Sottosanti L
AD  - Italian Medicines Agency, Rome, Italy.
FAU - Di Giovanni, Valentina
AU  - Di Giovanni V
AD  - Italian Medicines Agency, Rome, Italy.
FAU - Spina, Edoardo
AU  - Spina E
AD  - Sicilian Regional Pharmacovigilance Centre, University Hospital of Messina, 
      Messina, Italy; Department of Clinical and Experimental Medicine, University of 
      Messina, Messina, Italy.
FAU - Trifiro, Gianluca
AU  - Trifiro G
AD  - Department of Diagnostics and Public Health, University of Verona, Verona, Italy. 
      Electronic address: gianluca.trifiro@univr.it.
LA  - eng
PT  - Journal Article
DEP - 20210715
PL  - Netherlands
TA  - Eur Urol Focus
JT  - European urology focus
JID - 101665661
RN  - 1ULL0QJ8UC (dapagliflozin)
RN  - 6CW7F3G59X (Gabapentin)
RN  - JCX84Q7J1L (Celecoxib)
RN  - 13T4O6VMAM (Piroxicam)
RN  - 9FN79X2M3F (Lithium)
SB  - IM
MH  - Humans
MH  - Male
MH  - Adverse Drug Reaction Reporting Systems
MH  - *Urinary Retention/chemically induced/epidemiology
MH  - Gabapentin
MH  - Celecoxib
MH  - Piroxicam
MH  - Lithium
MH  - *Drug-Related Side Effects and Adverse Reactions/epidemiology
OTO - NOTNLM
OT  - Adverse drug reactions
OT  - Drug-induced urinary retention
OT  - Pharmacovigilance
OT  - Spontaneous reporting system database
EDAT- 2021/07/20 06:00
MHDA- 2022/12/06 06:00
CRDT- 2021/07/19 05:40
PHST- 2021/05/04 00:00 [received]
PHST- 2021/06/07 00:00 [revised]
PHST- 2021/07/02 00:00 [accepted]
PHST- 2021/07/20 06:00 [pubmed]
PHST- 2022/12/06 06:00 [medline]
PHST- 2021/07/19 05:40 [entrez]
AID - S2405-4569(21)00180-2 [pii]
AID - 10.1016/j.euf.2021.07.001 [doi]
PST - ppublish
SO  - Eur Urol Focus. 2022 Sep;8(5):1424-1432. doi: 10.1016/j.euf.2021.07.001. Epub 
      2021 Jul 15.