Risk to Newborns Leads FDA To Require New Labels for All Antipsychotic Drugs

The potential risk for extrapyramidal signs, or EPSs, and withdrawal symptoms in newborns whose mothers received antipsychotic drugs during the third trimester of pregnancy has led the FDA to subject the entire class of drugs to a labeling update. The update is designed to inform pregnant women and their physicians about the potential side effects of the medications.

More than two dozen products are affected by the action, including aripiprazole, which is marketed as Abilify; clozapine, which is marketed as Clorazil; haloperidol, which is marketed as Haldol; and chlorpromazine, which is marketed as Thorazine. Also included are medications that combine an antipsychotic and an antidepressant, such as the combination of olanzapine and fluoxetine, which is marketed as Symbyax.

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:

In addition, the FDA advised women to notify their health care professionals if they become pregnant or intend to become pregnant while taking antipsychotic medications. The agency also said patients should not stop taking their antipsychotic medications without first consulting their physicians because abruptly stopping these drugs can cause significant complications for treatment.