FDA requires child warnings on bladder drug

The FDA recently stated that a drug used to treat overactive-bladder conditions needs more specific warnings about the potential to cause hallucinations and agitation in children. The agency said it was proposing to update the precautions section to note reports of hallucinations and agitation were “prominent among pediatric cases.” The proposed label would also direct doctors to carefully monitor patients on the drug for central-nervous-system side effects.

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