Lithium gets some competition in this area...BD
The US Food and Drug Administration (FDA) has approved Johnson & Johnson's (J&J) atypical antipsychotic drug Risperdal (chemical name risperidone) for use in two types of treatment with children and adolescents. The approval was given yesterday, 22nd August. One application is for short treatment of schizophrenia in adolescents aged from 13 to 17 and the other is for short term treatment of manic or mixed episodes of bipolar I disorder in children aged between 10 and 17.
Lithium has been the only FDA approved pediatric drug for treating schizophrenia and bipolar disorder in these age groups until now.
FDA Approves Antipsychotic Risperdal For Adolescents And Children
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."
ReplyDeleteAccording 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
Gosh, after reading this, it sounds like the side effects are many and something that would need very careful monitoring too.
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