J&J's Ditropan to get stronger warnings

The US Food and Drug Administration says that the warning label on global health care major Johnson & Johnson's overactive bladder treatment Ditropan (oxybutynin) needs to be strengthened to include details of the potential risk of hallucination in children and the elderly.

The agency said that a review of adverse reactions linked to the drug that it conducted in November 2006 revealed there was a disproportionate number of central nervous system events in the pediatric population compared with adults. In total, 202 CNS events were reviewed, of which a higher proportion of pediatric adverse effects were CNS-related compared with those reported by adults using the drug, 31% versus 11%, respectively.

In addition, hallucination, which was the most commonly reported adverse event (27%), occurred at more than double the rate in the 60 year old and over population, compared with patients aged 17 to 59 (25% vs 11%). The FDA recommended that the product's labeling be revised to include its potential to cause anticholinergic CNS events, and that patients should be monitored for such effects.