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Risk to Newborns Leads FDA To Require New Labels for All Antipsychotic Drugs
Medications Pose Risks During Pregnancy
By News Staff
A complete list of affected drugs is available in a Feb. 22 safety announcement from the agency.
The FDA said that a search of its Adverse Event Reporting System database through Oct. 29, 2008, identified 69 cases of neonatal EPSs or withdrawal associated with antipsychotic drugs. Symptoms reported included agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder.
The agency said a majority of the cases were confounded by other factors, including use of other drugs known to be associated with withdrawal symptoms, such as antidepressants, benzodiazepines, nonbenzodiazepine hypnotics and opioids; prematurity; congenital malformations; and obstetrical and perinatal complications. However, some of the cases suggested that neonatal EPSs and withdrawal may occur with use of antipsychotics alone.
The agency issued the following guidance for physicians:
- Know that antipsychotic medications cross the placenta.
- Be aware that neonates exposed to antipsychotic medications during the third trimester are at risk for EPSs and/or withdrawal symptoms following delivery.
- Counsel patients about the benefits and risks of taking antipsychotic drugs during pregnancy.
- Monitor neonates exhibiting EPSs or withdrawal symptoms. Some recover within hours or days without specific treatment, but others may require prolonged hospitalization.
- Report adverse events involving antipsychotic drugs to the FDA's MedWatch program.
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