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In this study, treatment was associated with a higher incidence of akathisia and extrapyramidal symptoms, but it was not associated with a mean increase in weight or metabolic parameters or with prolactin increase or QTc prolongation, she noted.
This pilot investigation follows the drug safety communication from the Food and Drug Administration in February 2011 in which health care providers were notified that the pregnancy section of the medication label for the entire antipsychotic drug class was being changed to reflect the potential risks for extrapyramidal symptoms (EPS) or withdrawal symptoms noted in newborns whose mothers had been treated with these drugs during the third trimester of pregnancy.
29, 2008, identified 69 cases of neonatal extrapyramidal symptoms (EPS) or withdrawal associated with different antipsychotics, with symptoms that varied in severity.
Children and adolescents, compared with adults, are at increased risk for acute and intermediate adverse effects of psychotropic medications, including sedation, extrapyramidal symptoms (except for akathisia), withdrawal dyskinesia, prolactin-related adverse effects (especially in postpubertal females), weight gain, and dyslipidemia, as well as suicidal ideas and behaviors.
Special Considerations: Common adverse events in bipolar mania trials included somnolence and extrapyramidal symptoms, dizziness, and akathisia.
IM Geodon has the advantage of having "equal or better efficacy" than the shortacting antipsychotics used for decades in treating acute agitation in patients with a wide range of diagnoses, but it has far fewer side effects, particularly extrapyramidal symptoms, Dr.
sedation, falls, worsened behavior or disorientation/confusion, extrapyramidal symptoms (EPS) and tardive dyskinesia (TD)) on a monthly basis.
Confirming the benign safety profile observed in four previously completed Phase I clinical studies, CYR-101 was well tolerated with no evidence of the side-effects associated with typical and atypical antipsychotics, including weight gain, prolactin increase and extrapyramidal symptoms.