Animal models have revealed evidence of embryotoxicity, reduced litter size, slightly increased stillborn rate, and decreased mean birth rate. Epidemiological studies have suggested an increased risk of congenital abnormalities in pregnancy and the use of antidepressants in pregnancy may be associated with an increase in pre-term delivery. There are no controlled data in human pregnancy.

To monitor maternal-fetal outcomes of pregnant women exposed to antidepressant therapy, a National Pregnancy Registry for Antidepressants has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/

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.

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

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

Comments:
-Neonates whose mothers had taken this drug up until delivery have developed dyspnea, lethargy, colic, irritability, hypotension or hypertension, tremor or spasms, during the first few hours or days.
-If possible, this drug should be gradually withdrawn at least 7 weeks before the calculated date of confinement.
-A pregnancy exposure registry is available.

See references

A decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-The American Academy of Pediatrics classifies this drug as an agent whose effects on the nursing infant are unknown but may be of concern.
-Alternative agents (e.g., nortriptyline, paroxetine, sertraline) may be preferred when breastfeeding newborn or preterm infants, or when large doses are necessary.

See references