FDA Requires Updated Labels to Warn Pregnant Women of Antipsychotic Drug Dangers

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The US Food and Drug Administration has updated the Pregnancy section requirements for the labels for all antipsychotic drugs warning women about the potential risk of taking the medication during the third trimester of pregnancy. The new labeling will affect 20 different drugs sold under 23 different brand names.

According to a safety notification to healthcare professionals, the new drug labels will address the potential risk of extrapyramidal symptoms (EPS) and withdrawal syndromes in newborns. These symptoms include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing and difficulty in feeding.

The FDA has identified 69 episodes of neonatal EPS or withdrawal submitted to the FDA’s Adverse Event Reporting System (AERS) database through October 29, 2008. Onset of symptoms ranged from birth to one month later, and the severity varied as well. In some newborns, the symptoms subsided within hours or days without specific treatment; others required longer hospital stays and intensive care.

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Blood levels of the drugs involved were not provided in the reports and the agency says it was not possible to effectively determine whether the events resulted from drug toxicity or withdrawal. Most cases also involved other potential causes of the symptoms, such as other psychotropic drugs and medical problems associated with the pregnancy or delivery.

"However, there were some cases which suggest that neonatal EPS and withdrawal may occur with antipsychotics alone," the FDA said.

The new labeling law affects the following antipsychotic drugs:
• aripiprazole (Abilify)
• clozapine (Clozaril; FazaClo ODT)
• iloperidone (Fanapt)
• ziprasidone (Geodon)
• haloperidol (Haldol)
• paliperidone (Invega; Invega Sustenna)
• loxapine (Loxitane)
• molindone (Moban)
• thiothixene (Navane)
• pimozide (Orap)
• risperidone (Risperdal; Risperdal Consta)
• asenapine (Saphris)
• quetiapine (Seroquel; Seroquel XR)
• trifluoperazine (Stelazine)
• chlorpromazine (Thorazine)
• olanzapine (Zyprexa; Zyprexa Relprevv; Zyprexa Zydis)
• olanzapine and fluoxetine (Symbyax)
• fluphenazine
• perphenazine
• perphenazine and amitriptyline
• prochlorperazine
• thioridazine

Patients taking these drugs should notify their healthcare provider if they become pregnant or intent to become pregnant. Women should not abruptly stop taking antipsychotic medications if they become pregnant without talking to their doctors as this could cause significant complications for treatment.

Patients and health professionals are urged to report adverse events or side effects related to the use of antipsychotic drugs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by telephone at 1-800-FDA-1088, online at www.fda.gov/medwatch, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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