Saying the drug needs more-specific warnings, the federal agency said it was proposing to update the precautions section of the drug's label to note that reports of hallucinations and agitation were seen in many children and adults.
The drug, manufactured by Johnson and Johnson, has also mentioned warnings on its label that warns of insomnia, nervousness, confusion and other central nervous system risks.
However the federal authorities reviewed 202 reports of central nervous system side affects reported by users of ditropan and found that nearly 37 cases were reported in children under the age of 17 years old.
The FDA also found that in nearly 27 percent of under 17 groups, hallucinations were mentioned as a side affect, and in 25 percent of the adult group of 143 people hallucinations were also mentioned as a side affect.
The agency is now planning to hold a meeting to further discuss the side effects and issue strict warnings.
