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Medication News & Update

FDA staff stated that it reviewed 202 cases of CNS adverse events associated with oxybutynin, including 37 paediatric cases and 143 involving adults. The review showed that 27 percent of paediatric cases mentioned hallucinations, and 25 percent of cases in patients 60 years or older involved hallucinations. In patients aged 17 to 59 years, 11 percent of adverse event reports included hallucinations.

In its recommendations, the agency staff suggested that the drug's labelling state that "oxybutynin has the potential to cause anticholinergic CNS effects" and that among these types of adverse events reported, "hallucinations and agitation [were] prominent among paediatric cases, and confusion, hallucinations, and sedation prominent among reports involving geriatric use."