Importance: Clinical data on the use of overactive bladder (OAB) medications are limited by the physician interpretation of adverse effects rather than those that are patient reported.
Objective: The aim of the study was to evaluate the association between OAB medications and adverse drug events (ADEs) through the self-reporting U.S. Food and Drug Administration Adverse Event Report System database.
Study Design: The U.S. Food and Drug Administration Adverse Event Report System (FAERS) database was queried from 2004 to 2019. Adverse drug events were recategorized. Disproportionality analysis was used to detect the risk signals for each OAB medication and ADEs. χ 2 values were calculated to assess the association between ADEs and dosage.
Results: A total number of 14,102 reports were identified. The most frequently reported OAB medications were mirabegron (35%), transdermal oxybutynin (27%), and solifenacin (25%). Neuropsychiatric (NP) ADEs were highest with tolterodine and fesoterodine usage (16% and 15.6%, respectively) and transdermal oxybutynin had the lowest (6.5%). Increasing the dose of tolterodine or fesoterodine was not associated with increased NP ADEs. Oxybutynin had the highest risk of affect/mood disorder, agitation, and balance/movement disorder; however, it had the lowest risk of headache/migraine compared with all OAB medications. Mirabegron compared with all other OAB medications had the lowest risk of affect/mood disorder and agitation; however, it had the highest risk of headache and migraines.
Conclusions: The FAERS database not only is a repository of ADEs but also may represent evolving prescribing habits for OAB medications. Transdermal oxybutynin had the lowest NP ADEs and may be appropriate for selected individuals.
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Multi-center, prospective, non-interventional, observational study on the efficacy and safety of Mirabek in adult patients with overactive bladder.
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Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, Korea.
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Trends in Medicare Coverage of Overactive Bladder Medications in the United States.
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From the Urogynecology and Reconstructive Pelvic Surgery, MedStar Washington Hospital Center/Georgetown University, Washington, DC.
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Antibiotic therapy for treating overactive bladder is not supported by clinical evidence.
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A number of reports have suggested that the use of prolonged antibiotic treatment could be an effective therapy for patients with overactive bladder (OAB); however, this approach is contrary to existing recommendations regarding the prolonged non-specific use of antibiotics. The existing evidence in this area seems to be circumstantial and anecdotal but, despite this limitation, the use of long-term antibiotic therapy for OAB seems to be increasing. Review and synthesis of the existing evidence for use of antibiotic therapy in patients with OAB identify few studies - just seven papers and four conference proceedings - which are heterogeneous in their design, inclusion and exclusion criteria, treatment regimen employed, approach to the use of antimuscarinic medications, follow-up protocols, and measured outcomes.
View Article and Find Full Text PDFRisks of Dementia Associated With Anticholinergic Medication Compared to Beta-3 Agonist Among Older Patients With Overactive Bladder in Japan: The LIFE Study.
Int J Geriatr Psychiatry
January 2025
Department of Health Care Administration and Management, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.
Article Synopsis
- Anticholinergic drugs may lead to cognitive impairment, and this study specifically examined their risk of causing dementia in older adults in Japan compared to beta-3 agonists.
- The study involved over 1.4 million participants, with nearly 13,500 taking anticholinergics and around 24,700 using beta-3 agonists, all aged 65 and older with overactive bladder.
- Results indicated that users of anticholinergic drugs had a 22% higher risk of developing dementia compared to those using beta-3 agonists, suggesting a significant association between anticholinergic use and increased dementia risk.
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