This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

AU TGA pregnancy category: C
US FDA pregnancy category: Not Assigned

Risk summary: There are insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-A pregnancy exposure registry is available.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.

There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in neonates exposed to antipsychotic drugs during the third trimester of pregnancy. These complications have varied in severity; in some cases, symptoms have been self-limited and in other cases neonates have required intensive care unit support and prolonged hospitalization. Animal studies have revealed no evidence of teratogenicity, however, pregnant rats receiving 73 times the maximum recommended human dose (MRHD) during the period of organogenesis through lactation had an increased number of perinatal pup deaths. Impaired nursing by dams, low birth weight, and decreased body weight gain in pups were observed at 73 times MRHD, but not at 24 times the MRHD. There are no controlled data in human pregnancy.

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: http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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

Lactation studies have not been conducted to assess the effects of this drug on the breastfed infant or the effects on milk production.

Animal models developed milk levels of approximately 1- to 2-fold times maternal blood levels.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects on the breastfed infant from this drug or from the mother's medical condition.

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

Comment: The effects in the nursing infant are unknown.

See references