Bladder Drug Needs Stronger Warning for Children

April 2007

According to the Food and Drug Administration (FDA), a bladder drug used to treat overactive bladder conditions needs more specific warnings for children. Oxybutynin, sold under the brand name Diptropan, has the potential to cause hallucinations and agitation in children.

After reviewing 202 reports of central-nervous-system events, the FDA saw a higher incidence rate in children than adults. In 2006, out of 4.8 million prescriptions written for oxybutynin, 241,000 were for children age 16 and younger. The FDA mentioned 18,000 prescriptions were written for children age 5 or younger even though the drug is only approved for use in children age 5 and older.

Currently the drug’s label mentions the potential to cause central-nervous-system side effects, which include hallucinations, nervousness, and confusion. The proposed label would provide age-specific information and also warn doctors to carefully monitor patients for the side effects.