Animal studies have revealed evidence of embryotoxicity, fetotoxicity (including increased resorptions and dead fetuses), neonatal mortality, decreased offspring performance, and labor prolongation. Malformations occurred at maternally toxic doses. There is a possibility of permanent neurological damage in humans. There are no controlled data in human pregnancy.

Male animal models have revealed evidence of spermatocyte and sperm aberrations. There are no controlled data in human males.

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.

Use is recommended only if clearly needed and the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned.

Risk Summary: Malformative risk in pregnant women is unknown. Extrapyramidal side effects and withdrawal symptoms have been reported in exposed neonates, and embryo- and fetotoxicity have occurred in animal models.

Comments:
-Some experts recommend avoiding use during the first trimester; local protocol and/or manufacturer product information should be consulted regarding use during pregnancy.
-The dose and duration of treatment in pregnant patients should be as low and short as possible.
-Neonates exposed during the third trimester are at risk of developing severe and/or prolonged side effects (e.g., agitation, hyper/hypotonia, tremor, somnolence, respiratory distress, feeding disorder). The side effects have varied in severity and duration, with some neonates requiring intensive care support and prolonged hospitalization.
-If used during labor, this drug should be withheld until the cervix is dilated 3 to 4 cm.
-Exposed neonates should be monitored for the signs/symptoms of extrapyramidal syndrome and/or withdrawal.

See references

This drug is known to cause hyperprolactinemia, and has resulted in galactorrhea in non-lactating female patients.

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-Use is contraindicated in some parenteral formulations. The manufacturer product information should be consulted regarding parenteral use during lactation.
-The American Academy of Pediatrics considers use of this drug during lactation unknown but may be of concern.
-Breastfed infants exposed to this drug should be monitored for sedation and developmental milestones.

See references