Are Antipsychotic Medications Safe During Pregnancy?

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Psychiatric illnesses are prevalent in about 25% of the US adult population.1 Approximately 21% to 33% of women are prescribed antipsychotic drugs during pregnancies,and about 50% experience a relapse of symptoms related to mental illness.2,3 In 2015, the Pregnancy and Lactation Labeling Rule removed the A, B, C, D, and X categories for medications prescribed during gestation. Labels now include more information and detail about these pharmaceuticals regarding potential risks to a mother and fetus.4 As with all other pharmacotherapies during pregnancy, teratogenicity and medicinal adverse effects (AEs) must be balanced against the risk of nonpharmacotherapy.


Antipsychotic medications often are prescribed to treat people with a wide range of psychiatric conditions, including schizophrenia, bipolar disorder, depression, anxiety, and personality disorders.5 Commonly, second-generation antipsychotic medications are selected for pregnant women. Olanzapine, haloperidol, risperidone, and quetiapine freely pass through the placenta.5 During gestation, when an antipsychotic agent is strongly indicated, it is prudent to select one of the second-generation versions or haloperidol.

Risks vs Benefits

Physicians should always consider the risk-to-benefit ratio of these medicines for both the pregnant woman and the fetus.6 The National Pregnancy Registry for Atypical Antipsychotics was established to evaluate the safety and efficacy of these drugs during pregnancy and the postpartum period.4,6

Even during the first trimester of pregnancy most antipsychotic medications prescribed to women, are documented to cause few major fetal malformations.7 Research during 487 pregnancies revealed that the risk of a malformed infant previously exposed in utero to antipsychotic drugs was 1.4%, compared with 1.1% for those not exposed.6 Risperidone, however is an exception, because evidence has shown that it results in more cardiac malformations and congenital anomalies than do other medications.7


Maternal complications, such as increased weight gain, gestational diabetes mellitus, hypertension, and venous thromboembolism, are reported in pregnant women prescribed antipsychotic medications.3 Sudden discontinuation of these drugs might interfere with activities of daily living, allow more psychotic symptoms in the mother, impair prenatal self-care, and increase the risk for suicide or infanticide.8 Fetal complications might include prematurity, intrauterine growth retardation, distress, suboptimal birth weights, low Apgar scores, neonatal hypoglycemia, and congenital defects. Stillbirths can occur as well.9

Neonates exposed to antipsychotic medications in utero can experience withdrawal symptoms after delivery. They might exhibit agitation, feeding disorders, hypotonia, hypertonia, respiratory distress, somnolence, and tremor.10 Extrapyramidal symptoms, such as abnormal movements, restlessness, stiffness, and tremors, may occur more often when prescribing first-generation rather than with second-generation antipsychotic drugs.11 These clinical manifestations occur from a few hours after birth to 1 month later. The management of withdrawal symptoms is not clear, though symptomatic intervention is recommended.11

However, studies have shown that documented AEs are not significantly increased in the patients or infants exposed to antipsychotic medications compared with those of a control group.7 Furthermore, pregnant women with mental illness who remain untreated or who discontinue these drugs during a gestation evidence increased maternal morbidity12;they also exhibit more complications, such as placental abnormalities, antepartum hemorrhage, or preeclampsia.6 Hence, when medications are indicated, physicians should encourage patients to continue taking these medications after being educated about the risks and benefits of pharmacotherapy.6

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