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FDA recently announced that the 'Pregnancy' sections of labeling for all antipsychotic medications will now have to include wording about the potential risk for extrapyramidal side effects and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.
FDA recently announced that the 'Pregnancy' sections of labeling for all antipsychotic medications will now have to include wording about the potential risk for extrapyramidal side effects (EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.
FDA decided to add the warning to the drugs' labeling after a review of the Adverse Event Reporting System (AERS) database through October 29, 2008, identified 69 cases of newborn extrapyramidal or withdrawal symptoms including agitation, hypertonia or hypotonia, tremor, somnolence, respiratory distress, and feeding disorders thought to be associated with antipsychotic drug use in mothers during pregnancy. The time to onset of symptoms in newborns ranged from birth to 1 month after birth. Symptom severity was also variable, ranging from speedy resolution in hours or days to need for intensive care unit admission and prolonged hospitalization.
While FDA is requiring all products containing antipsychotic agents to have updated prescribing information, they did note in this safety communication that their ability to draw conclusions from the AERS data was confounded by concomitant use of other drugs known to be associated with withdrawal symptoms (eg, antidepressants, benzodiazepine and non-benzodiazepine hypnotics, and opioids), prematurity, congenital malformations, obstetrical and perinatal complications (eg, placental problems and pre-eclampsia), and by the fact that newborn blood levels were not available to support the association.
Formulary Editorial Advisor Craig I. Coleman, PharmD, an associate professor at the University of Connecticut School of Pharmacy, Storrs, Conn., emphasized, "There is a paucity of data evaluating antipsychotic medications in pregnancy, and this poses a serious problem. Since the onset of schizophrenia commonly occurs in the second and third decades of life-the peak childbearing years-a large number of women who are pregnant or may become pregnant may require antipsychotic drug therapy," he continued.
FDA officials are now recommending healthcare professionals be aware of the effects of antipsychotic medications on newborns when such medications are used during pregnancy. The agency is also warning patients about the hazards of stopping their antipsychotic medications without consulting their doctor; a decision that can result in significant complications in their treatment.
Antipsychotic medications are used to treat psychiatric disorders including schizophrenia and bipolar disorder. Drug entities affected by this labeling change include those containing aripiprazole, asenapine, chlorpromazine, clozapine, fluphenazine, haloperidol, iloperidone, loxapine, molindone, olanzapine, paliperidone, perphenazine, pimozide, prochlorperazine, quetiapine, risperidone, thioridazine, thiothixene, trifluoperazine, or ziprasidone.
FDA. FDA Drug Safety Communication: Antipsychotic drug labels updated on use during pregnancy and risk of abnormal muscle movements and withdrawal symptoms in newborns. February 22, 2011. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm243903.htm. Accessed February 24, 2011.
FDA. Antipsychotic drugs: Class labeling change - Treatment during pregnancy and potential risk to newborns. February 22, 2011. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm244175.htm. Accessed February 24, 2011.