IntroductionAcute urinary retention (AUR) occurs at an average rate of 4.5 cases per 1,000 individuals per year and generates 0.2% of emergency room visits. Medication-associated retention is not uncommon yet is often not well addressed when prescribing a new medication. This study aims to identify and characterize medications with the highest reported rate of AUR.
MethodsThe FDA Adverse Event Reporting System, a public database utilized for collecting information on spontaneously reported adverse drug events, was queried to identify the top 12 medications with the highest frequency of AUR events from 2010 to 2023. Proportional reporting ratios (PRR) and chi-square (X2) were calculated to evaluate the association between AUR and each reported medication. In accordance with prior studies, we sought to detect significant signals, which indicate a statistical association between an adverse event and a drug, by the minimum criteria of co-occurrence of three or more, PRR of two or more, and X2 of four or more.
ResultsIn 23,221 reports, the top 12 medications accounted for 4,443 (19.13%) cases. Adverse effects were similar in males (46.79%) and females (46.57%), with the highest prevalence among patients aged 18-64 years (34.98%) followed by 65-85 years (28.65%). The medications were divided into five categories based on primary therapeutic uses: neuropathic pain and neuropsychiatric (NPN, 45.16% of cases), overactive bladder (24.12%), immunomodulatory (17.07%), pain management (7.02%), and hematologic (6.63%). Some cases involved multiple medications. Ten medications yielded significant signals, with five possessing anticholinergic properties (three indicated for psychiatric disorders, and two for OAB). The two overactive bladder medications, fesoterodine fumarate (PRR=69.23, N=461, X2=30,417.56) and mirabegron (PRR=34.74, N=695, X2=22,119.13), had the highest statistically significant signals. Six NPN drugs, natalizumab, and fentanyl also exhibited significant signals.
ConclusionSignificant signals indicate AUR as an adverse effect for 10 of the top 12 drugs, with mirabegron and fesoterodine fumarate exhibiting the strongest association with AUR. Notably, the NPN category comprised half of the top 12 medications causing AUR. Unlike OAB medications, prescribers may not be aware that NPN medication have a side effect of AUR. Future efforts should prioritize enhancing awareness and monitoring of medication-related urinary retention adverse effects.
| Medication Category | Medication | N | Proportional Reporting Ratio (95% two-sided CI) | Chi-Square (X2) |
| Neuropathic Pain and Neuropsychiatric | Pregabalin | 472 | 3.57 (3.27-3.92)* | 859.83* |
| Olanzapine | 358 | 7.28 (6.55-8.08)* | 1,910.34* | |
| Quetiapine | 351 | 8.39 (7.55-9.32)* | 2,252.32* | |
| Risperidone | 335 | 4.03 (3.62-4.89)* | 752.92* | |
| Duloxetine Hydrochloride | 328 | 7.13 (6.39-7.95)* | 1,705.51* | |
| Sertraline Hydrochloride | 320 | 4.91 (4.39-5.49)* | 984.99* | |
| Overactive Bladder | Mirabegron | 695 | 34.74 (32.26-37.42)* | 22,119.13* |
| Fesoterodine Fumarate | 461 | 69.23 (63.34-75.67)* | 30,417.56* | |
| Immunomodulatory | Adalimumab | 469 | 0.77 (0.70-0.84) | 31.78* |
| Natalizumab | 349 | 2.09 (1.88-2.32)* | 195.46* | |
| Pain Management | Fentanyl | 336 | 3.52 (3.16-3.92)* | 597.83* |
| Hematologic | Lenalidomide | 318 | 0.92 (0.82-1.02) | 2.35 |
