FDA Recommends Precautions for Children and Elderly Taking Ditropan

A New Label is Recommended to Highlight Areas of Concern

The FDA has recommended that Johnson & Johnson revise the labeling of their drug, Ditropan, due to hallucinations and other central nervous system issues noted in pediatric and geriatric age groups. Food and Drug Administration staff released documents on Monday recommending the changes, as well as asking physicians to carefully monitor their patients who use the drug. It is concerned that physicians and caretakers lack awareness of the dangers for children and elderly people taking the medication.

Over-active bladder sufferers use Ditropan, or its generic version, oxybutynin, to ease bladder incontinence, spasms, and uncontrolled urges to urinate. The drug acts as an anticholinergic, which restricts nerve impulses to the bladder, thereby reducing leakage and the need to urinate frequently. In addition, it helps to increase the bladder capacity for some people. Patients with various neurological conditions, including Spina Bifida, have more independence when they are able to control bladder issues.

The FDA approved Ditropan in the mid-seventies. It was accepted for use in children in 2002. A study done by Verispan Vector One® estimates that 241,000 Ditropan prescriptions were issued for patients under the age of 16 in 2006. Approximately 38,000 children were prescribed oxybutynin, even though oxybutynin is not approved for use in that age group. The study also points out that 31% of pediatric patients experienced some type of central nervous system reaction to the drug, as opposed to 11% of adults. No doubt, children taking Ditropan need closely supervised.