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:
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