Johnson & Johnson’s drug Ditropan for overactive bladders needs stronger cautions about the risk of hallucination and similar problems in children and older patients, U.S. Food and Drug Administration staff said in documents released on Monday.
The drug, also known as oxybutynin, already lists insomnia, nervousness, confusion and other central nervous system risks on its label, but staff reviewers said more explicit cautions are needed.
Specifically, labeling should point out that the drug can cause such problems and that 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 dated March 5.
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 Wednesday to review use of Ditropan and several other drugs in children.
Cholesterol drug also reviewed
In a separate memo, other agency staffers said a review of side effects in children taking Novartis AG’s cholesterol drug Lescol showed no unique risk.
But the staff added that their review of the drug, also known as fluvastatin, was limited by the small number of reports, some of which were incomplete.
While there were no reports of muscle or liver problems with Lescol so far, the agency said it would continue to monitor the drug for any future safety signals.
“Statin-associated muscle and liver events are well documented in the adult population and the lack of pediatric reports may be related to limited usage of fluvastatin in the pediatric population and underreporting of adverse events,” FDA staff said in a Jan. 25 memo.
The FDA’s panel of outside experts is also scheduled to discuss Roche AG’s weight loss drug Xenical and Novartis’ Sandostatin, approved to treat a hormonal disorder called acromegaly.