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Johnson, is prescribed to treat psychiatric disorders including schizophrenia, bipolar disorder and behavioral problems in people with autism.
Behavioral therapies are widely used to help children with ASDs learn to talk and communicate, develop physically, and deal with other people more effectively.
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There are also studies which show that Risperidone has been used with some success in the treatment of children with ADHD and especially those with certain co-morbid conditions.
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Risperdal is commonly prescribed as an anti-psychotic drug to treat a variety of mental and mood disorders including schizophrenia, bi-polar disorder and irritability associated with autism.
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Serum prolactin levels were not measured during the carcinogenicity studies of oral risperidone; however, measurements taken during subchronic toxicity studies showed that oral risperidone elevated serum prolactin levels 5- to 6-fold in mice and rats at the same doses used in the oral carcinogenicity studies.
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Well, the company then proposed -- rather than giving guidance on how to dose, the company proposed to repeat the text that the efficacy and safety of Risperdal in children has not been established to repeat that once more under the Dosing and Administration section of the label.
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Johnson never acknowledged it, the company, as well as its competitors, already knew from multiple studies that Risperdal alone caused highly elevated prolactin levels even at the recommended low doses for children.
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Antipsychotic drugs are basically classified into two classes: First generation antipsychotics (FGAs) and second generation antipsychotics (SGAs).
In 2003, the FDA also approved Risperdal for the short-term treatment of adults and children 10 and older with bipolar disorder who experience mania, or episodes of unusually excited moods.
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The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.
Johnson also agreed to five settlements over claims that its antipsychotic medication increased breast-tissue growth in boys, according to a Bloomberg News report.
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