TOPLINE

Among four pediatric bladder drugs, oxybutynin had the highest proportional reporting of psychiatric reactions. However, no drug met the criteria for a safety signal for psychiatric or nervous system disorders.

METHODOLOGY

• Researchers analyzed spontaneous reports of adverse drug reactions among children and young people (age, 0-19 years) from a UK-based system to assess neuropsychiatric reactions to bladder drugs, with data collected up to December 2025.
• Drugs included oxybutynin, solifenacin, tolterodine, and mirabegron. Reactions coded for psychiatric and nervous system disorders were analyzed.
• The primary outcome was the frequency of suspected neuropsychiatric adverse drug reactions and whether any drug showed disproportionate reporting.
• The researchers calculated proportional reporting ratios (PRRs) by comparing the proportion of reactions for each drug with that of the other three drugs combined.
• A PRR of at least 2, a chi-square value of at least 4, and a minimum of three reports were required to flag a possible disproportionality signal.

TAKEAWAY

• The researchers identified 297 spontaneous reports of suspected adverse drug reactions, with oxybutynin accounting for 224 reports.
• Psychiatric disorders accounted for 27.3% of suspected reactions with oxybutynin and 26.3% with mirabegron. Solifenacin and tolterodine had lower proportions (12.2% and 16.0%, respectively).
• Oxybutynin was associated with a higher proportion of reported psychiatric disorders (PRR, 1.56; 95% CI, 1.075-2.255). However, oxybutynin and the other drugs did not meet the criteria for a safety signal.
• No drug was linked to a higher proportion of reported nervous system disorders.

IN PRACTICE

"[The] data suggest a different pattern for suspected psychiatric ADR [adverse drug reaction] reporting compared to the short-term prospective studies and strengthen the case for larger studies exploring the association between paediatric anticholinergic exposure and long-term cognitive, behavioural, and education outcomes," the researchers wrote.

SOURCE

The study was led by Khaled Aboukhalaf of Alder Hey Children's Hospital in Liverpool, England. It was published online on October 6 in the Journal of Pediatric Urology.

LIMITATIONS

Researchers lacked reliable data on how many children had been prescribed each drug. Reports often lacked details such as dose, treatment length, or other medicines. The analysis relied on voluntary reports that may have been biased by warnings, media coverage, or litigation.

DISCLOSURES

The study did not report any source of funding or competing interests.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.