J&J Bladder Drug Needs Strong Warning
2 CommentsBy Ed Silverman // April 9th, 2007 // 11:33 am
The FDA wants stronger warnings about the risk of hallucination and similar problems in children and older patients associated with Ditropan. 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 the risks have been reported in patients taking the drug. Doctors should also monitor for symptoms, according to a March 5 FDA memo written in advance of a meeting on Wednesday of the agency’s pediatric review commitee.
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. The 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.
Source: Reuters
The FDA briefing can be read here.
[tags]Ditropan, FDA, Johnson & Johnson, Safety[/tags]
Lew
It’s interesting to note that there are many Medicare drug plans that have oxybutinin or the extended version as the only preferred product on their formularies. Is this practice medically defendable given the seemingly severe CNS effects? Will CMS react in these cases?
ed
Hi Lew,
Those are good questions and, I confess, I don’t know the answers right now. I suspect there will be some movement after the advisory committee meets, or rather, the FDA makes a decision based on whatever the panel recommends. Let’s remember to follow up!
Cheers
ed