Johnson & Johnson’s bladder drug Ditropan needs stronger cau tions about the risk of hallucination and similar problems in children and older patients, Food and Drug Administration staff said in documents released yesterday.
The drug, also known as oxybuty nin, already lists insomnia, nervous ness, confusion and other central nervous system risks on its label, but staff reviewers said more expli cit cautions are needed.
Specifically, labeling should point out that the drug can cause such problems and the risks have been reported in patients taking the drug. It should also call on doctors to monitor for symptoms, they wrote in a memo last month.
The staff reviewed 202 reports of central nervous system side effects in Ditropan patients — 37 in those 17 and younger and 143 in adults; no age was reported in 22 cases. Those 202 reports mentioned hallucinations in 27 percent of the pediatric cases and in 25 percent of those aged 60 and older. Hallucinations were reported in 11 percent of cases for adults aged 17 to 59.
The documents were released ahead of an FDA advisory panel meeting scheduled for tomorrow to review use of Ditropan and several other drugs in children.