The 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 |
