Ditropan side effects in children to be reviewed by FDA
On April 11, 2007, an FDA advisory committee will discuss concerns about Ditropan side effects for children. The committee will review whether the maker of this drug is doing enough to warn about the increased risk of problems with hallucinations, which could result in serious physical injury or even death in some situations.
Ditropan (generic oxybutynin) is used to treat overactive bladder conditions , and it has been approved for use in children as young as five. The FDA Pediatric Advisory Committee will review indications that there are a disproportionate number of adverse events involving the central nervous system for children when compared to the number of problems for adults.
Side effects of Ditropan were previously reviewed by the FDA Pediatric Advisory Committee in November 2006 during an abbreviated presentation. However, FDA staff members requested a complete discussion and assessment of the risk of hallucination problems in children after a review of over 200 reported events of Ditropan side effects. Out of all reported central nervous system problems, hallucinations were the most common side effect for children, accounting of over 25% of the pediatric adverse events.
The Ditropan (oxybutynin) warning label currently indicates that the medication could cause central nervous system side effects, including agitation, confusion, nervousness, insomnia and hallucinations. However, the full extent of the problem in children may not be accurately described as there is no indication that children face an increased risk. It is likely that the FDA advisory committee will recommended stronger warnings which indicate that Ditropan hallucination side effects are “prominent among pediatric cases”. The FDA often relies on the recommendations of their advisory committees in determining how to best protect consumers.
Oxybutynin was first approved in the United States in 1975, but approval for use in children was not granted by the FDA until 2002. For children, Ditropan tabs/syrup are indicated for relief of bladder instability and Ditropan XL pediatric is indicated for treatment of children with symptoms of overactivity associated with a neurological condition, such as spina bifida.
In 2006, there were approximately 4.8 million Ditropan prescriptions written. Children under 17 years old received nearly 250,000 of those prescriptions. Even though the drug is only approved for use in children at least 5 years old, about 18,000 of the prescriptions written in 2006 were for children under five.
Ditropan is manufactured by Johnson & Johnson. Recently, the large pharmaceutical and medical product maker has been the subject of several lawsuits for other products which contained dangerous side effects which they failed to warn about, including:
FREE DITROPAN SIDE EFFECTS CONSULTATION
If your child has experienced Ditropan problems with hallucinations which resulted in a serious physical injury, request a free legal consultation.
2 Comments • Add Your Comments
C Mack says:
My daughter is 4 and was prescribed this for an overactive bladder, I’m not too happy about it reading these coments, no side effects yet apart froma headache and tunny ache
Posted on April 22, 2010 at 9:34 am
M says:
The experience my daughter has had with this drug is horrible. When your child is young it is hard for them to express cognitive side effects and my daughter was prescribed this as a baby through to high school. As my daughter grew, the doctors kept raising her dosage amount, carelessly not taking account of the anticholinergic burden to her brain. Her symptoms got so bad that I had to remove her from school and the doctors started giving her more medicine to treat her symptoms. I did a lot of research and took her off of the ditropan against her doctors orders; all her symptoms went away. Although, I think she has permanent damage to her brain. Her symptoms included twitching episodes that looked like myoclonus, severe irregularities in blood pressure and heart rate homeostasis, difficulty breathing, and cognitive decline. This drug messed her up for a long time- complicating her ability to learn in school and creating severe panic attacks.
Posted on April 2, 2021 at 6:11 pm