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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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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).

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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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