FDA approves Risperdal's use in children
The Food and Drug Administration on Wednesday approved a widely used adult psychiatric drug for the treatment of schizophrenia and bipolar disorder in children and adolescents.
The action permits use of Risperdal for schizophrenia in youths aged 13 to 17 and for bipolar disorder in those aged 10 to 17, FDA said.
posted by jayson blair at 10:31 AM
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Bloomberg News reported, "In trials, 27 percent of those receiving the highest dosage of Risperdal had symptoms of neurological side effects that cause involuntary jerking or movements, compared with 5 percent of patients on placebos."
According to Risperdal's FDA package insert showing the results of two 8-week clinical trials of pediatric patients, 46% of the kids on Risperdal suffered movement disorders including tremor, dystonia, automatism (tics), dyskenisia or parkinsonism, vs. 8% on placebo. That's a 475% greater risk for movement disorders in children on Risperdal!
In many cases these movement disorders are irreversible and will grow worse over time. In other words, the brain damage will be permanent and progressive.
A portion of the FDA package insert is copied below.
http://www.fda.gov/MedWatch/safety/2006/Oct_PIs/RisperdalTabs_PI.pdf
RISPERDAL (risperidone)
Incidence of Treatment-Emergent Adverse Events in Two 8-Week, Placebo-Controlled Trials in Pediatric Patients with Autistic Disorder
Adverse reaction RISPERDAL Placebo
Somnolence 67% 23%
Appetite increased 49% 19%
Confusion 5% 0%
Saliva increased 22% 6%
Constipation 21% 8%
Dry mouth 13% 6%
Fatigue 42% 13%
Tremor 12% 1%
Dystonia 12% 6%
Dizziness 9% 3%
Automatism 7% 1%
Dyskinesia 7% 0%
Parkinsonism 8% 0%
Upper respiratory tract infection 34% 15%
Weight increase 5% 0%
Tachycardia 7% 0%
Ben Hansen
Institute for Nearly Genuine Research
Traverse City, Michigan
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