On February 22, 2011, the Food and Drug Administration (FDA) announced that the labeling of all antipsychotics have changed to warn healthcare professionals about risks associated with use during pregnancy to newborns.
The new drug labels will now contain additional and more consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs) and withdrawal symptoms in newborns whose mothers were treated with these medications during the third trimester of pregnancy. The symptoms of extrapyramidal signs and withdrawal seen in newborns included agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding.
This pregnancy labeling change was brought about after the FDA reviewed the Adverse Event Reporting System (AERS) database. There were 69 cases of neonatal toxicity or withdrawal associated with antipsychotic use during the third trimester of pregnancy. The length and severity of symptoms differed, as some newborns had resolution of symptoms within hours or days without medications, while others required intensive care and prolonged hospitalization.
Antipsychotics are indicated in the treatment of schizophrenia and bipolar disorder, and more recently have been increasingly used as adjunct therapy in treating major depressive disorders. All of the antipsychotic medications are included in the labeling change. This includes Abilify, clozapine, Geodon, Haldol, Invega, Moban, Navane, Orap, Risperdal, Saphris, Fanapt, Loxitane, Seroquel, Thoraxine, Stelazine, Zyprexa, Symbyax, fluphenazine, perphenazine, prochlorperazine, and thioridazine.
It is important that healthcare professionals be aware that antipsychotic administration during the third trimester of pregnancy will increase the risk of adverse effects in newborns. If these adverse effects are seen, the FDA advises prescribers to report them to MedWatch, which can be found at: www.Fda.gov/MedWatch/report.htm. Patients should be made aware of these findings, but should not stop taking these medications without consulting a physician. Further information regarding the FDA's labeling change requirement can be found on their website www.fda.gov.