Use is not recommended.

US FDA pregnancy category: Not assigned.

Risk Summary: There are no data available to inform of a risk for birth defects or miscarriage.

Comments:
-A pregnancy exposure registry is available.
-Neonates exposed to antipsychotic drugs during the third trimester of pregnancy should be monitored for extrapyramidal and/or withdrawal symptoms post-delivery.
-Some experts recommend that women of childbearing potential should use highly effective contraceptives, including the use of barrier methods with the use of systemic hormonal contraceptives, during and for at least 10 weeks after discontinuing treatment.

Animal models have revealed evidence of fetal developmental toxicity (e.g. low body weight, skeletal malformations, or underdeveloped renal papillae) at doses 0.2 to 3.5 times the maximum recommended human dose experienced. Impaired fertility was observed in female animal models at all dose levels. There are no controlled data in human pregnancy.

There have been reports of extrapyramidal and withdrawal symptoms in neonates exposed to antipsychotic drugs during the third trimester of pregnancy. These complications have varied in severity, from self-limited to needing intensive care unit support and prolonged hospitalization.

To monitor the outcomes of pregnant women exposed to atypical antipsychotics, a National Pregnancy Registry for Atypical Antipsychotics has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves. For additional information: https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/atypicalantipsychotic/.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Safety has not been established.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-Some experts recommend that breastfed infants should be monitored for akathisia, extrapyramidal symptoms, restlessness, somnolence, and vomiting.
-Use of alternative agents in newborn or preterm infants may be preferred (e.g., haloperidol, olanzapine, quetiapine, risperidone).

See references