logoThe U.S. Food and Drug Administration (FDA) is informing healthcare professionals that it has updated the Pregnancy section of drug labels for the entire class of antipsychotic drugs.

The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy. 

Antipsychotic drugs are used to treat symptoms of psychiatric disorders such as schizophrenia and bipolar disorder, and have been shown to improve daily functioning in individuals with these disorders. Common brand names for antipsychotic drugs include Haldol, Clozaril, Risperdal, Zyprexa, Seroquel, Abilify, Geodon, and Invega (see List of Antipsychotic Drugs below). 

Healthcare professionals should be aware of the effects of antipsychotic medications on newborns when the medications are used during pregnancy. Patients should not stop taking these medications if they become pregnant without talking to their healthcare professional, as abruptly stopping antipsychotic medications can cause significant complications for treatment. 

The symptoms of EPS and withdrawal in newborns may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding. In some newborns, the symptoms subside within hours or days and do not require specific treatment; other newborns may require longer hospital stays.

Additional Information for Patients

  • Notify your healthcare professional if you become pregnant or intend to become pregnant while taking an antipsychotic medication.

  • Do not stop taking your antipsychotic medication if you become pregnant without first talking to your healthcare professional. Abruptly stopping antipsychotic medication can cause significant complications in your treatment.

  • Talk to your healthcare professional if you have concerns about any treatment you are receiving during pregnancy.

  • Report serious side effects from the use of antipsychotic drugs to the FDA MedWatch program.

List of Antipsychotic Drugs
 

Brand Name

Generic Name

Abilify

aripiprazole

Clozaril

clozapine

FazaClo ODT

clozapine

Fanapt

iloperidone

Geodon

ziprasidone

Haldol

haloperidol

Invega

paliperidone

Invega Sustenna

paliperidone

Loxitane

loxapine

Moban

molindone

Navane

thiothixene

Orap

pimozide

Risperdal

risperidone

Risperdal Consta

risperidone

Saphris

asenapine

Seroquel

quetiapine

Seroquel XR

quetiapine

Stelazine

trifluoperazine

Thorazine

chlorpromazine

Zyprexa

olanzapine

Zyprexa Relprevv

olanzapine

Zyprexa Zydis

olanzapine

Symbyax

olanzapine and fluoxetine

No Current Brand Name

fluphenazine

No Current Brand Name

perphenazine

No Current Brand Name

perphenazine and amitriptyline

No Current Brand Name

prochlorperazine

No Current Brand Name

thioridazine