WASHINGTON -- All antipsychotic drugs, including older agents as well as second-generation products, must contain new label information regarding their use in pregnancy, the FDA said.
In particular, the new labeling will address the risk of extrapyramidal symptoms (EPS) and withdrawal syndromes in newborns.
"FDA has updated the Pregnancy section of drug labels for the entire class of antipsychotic drugs to include consistent information about the potential risk for EPS and/or withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy," the agency said in a notification to healthcare professionals.
The FDA has identified 69 episodes of neonatal EPS or withdrawal in adverse event reports submitted to the agency through October 2008.
Among the symptoms listed in the reports: agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder.
Tuesday, February 22, 2011
FDA Orders New Cautions on Antipsychotic Drugs - MedPage Today
via medpagetoday.com
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