Animal models have revealed evidence of decreased fetal body weight and delayed ossification in pups exposed to doses at least 10 times the maximum recommended human dose (MRHD) during ossification. Decreased numbers of live-born pups, early postnatal pup mortality, lower pup weight gain, and developmental delay were observed at maternally toxic doses. There are no controlled data in human pregnancy.

Epidemiological data have suggested that the use of SSRIs, particularly in late pregnancy, may increase the risk of PPHN.

In a study of patients with a history of major depression who were euthymic at the beginning of pregnancy, those who discontinued antidepressant medication during pregnancy were more likely to experience a relapse of major depression than patients who continued antidepressant medication.

To monitor the outcomes of pregnant women exposed to antidepressant, a National Pregnancy Registry for Antidepressants 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/antidepressants/

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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 not recommended unless clearly needed.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.

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

Comments:
-A pregnancy exposure registry is available.
-Some experts recommend avoiding use during the third trimester.
-Neonates exposed during the third trimester are at risk of developing severe and/or prolonged side effects (e.g., agitation, hyper/hypotonia, hyperreflexia, jitteriness, tremor, seizures, somnolence, respiratory distress, cyanosis, apnea, hypoglycemia, vomiting, feeding disorder/difficulties, temperature instability irritability, constant crying). The side effects usually arise within 24 hours of delivery and have varied in severity and duration, with some neonates requiring intensive care support and prolonged hospitalization.
-Exposed neonates should be monitored for the signs/symptoms of persistent pulmonary hypertension of the newborn (PPHN), serotonin syndrome, and/or withdrawal.

See references

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: Unknown
Excreted into animal milk: Yes

Comment: The effects in the nursing infant are unknown.

See references