ANTIPSYCHOTIC DRUG LABELS UPDATED ON USE DURING PREGNANCY AND RISK OF ABNORMAL MUSCLE MOVEMENTS AND WITHDRAWAL SYMPTOMS IN NEWBORNS

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.

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.

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