FDA Recommends Precautions for Children and Elderly Taking Ditropan

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.

Side-effect warnings have always stated that Ditropan could cause a variety of symptoms, including dry mouth, dizziness, insomnia, nervousness, and heat prostration. While hallucinations have always been listed, only now has the FDA insisted that the manufacturer highlight their significance. This is not news to parents, however. Many have complained of nightmares, as well as other neurological symptoms, in their children when taking Ditropan. Most doctors and pharmacists have been quick to dismiss the concerns, even though documentation has existed. This report has validated what parents have known for years.

There are alternatives. The FDA has not advised to discontinue using Ditropan, but it is always wise to consult with a doctor when concerns exist. Oral medications, such as Detrol, Sanctura, and Vesicare are options. Oxytrol, a oxybutynin transdermal system, or skin patch, is another choice. However, it cannot be used in patients with sensitive skin. Keep in mind that no studies exist to show how these drugs affect pediatric patients.

If you, or someone you know, take Ditropan and are in one of the targeted groups, please consult with your doctor. Always seek medical help, or report any reactions, immediately. For a full list of adverse reactions, request a drug fact sheet, or package insert, from your pharmacist.

http://www.ortho-mcneilpharmaceutical.com/products/pi/pdfs/Lg%20Ditropan%20PI.pdf

http://money.cnn.com/2007/04/09/news/companies/bc.drugs.children.reut/index.htm?section=money_latest

http://www.sciam.com/article.cfm?alias=jj-bladder-drug-needs-str&chanId=sa003&modsrc=reuters