Animal studies have revealed evidence of embryofetal toxicity and effects on postnatal development, including teratogenicity, at doses greater than human therapeutic doses, which were also maternally toxic. There are no controlled data in human pregnancy.

Published data on pregnant women, with more than 2,500 exposed outcomes, indicate no malformative feto/neonatal toxicity. The results of a prospective comparative study (n=396 pregnant women) indicate that citalopram use during embryogenesis is not associated with an apparent major teratogenic risk in humans; however, human spontaneous abortion has been reported.

Neonates exposed to SSRIs and SNRIs late in the third trimester have uncommonly reported clinical findings including respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These effects have mostly occurred either at birth or within a few days of birth. These features are consistent with either a direct toxic effect of SSRIs and SNRIs, or possibly a drug discontinuation syndrome; in some cases, the clinical picture is consistent with serotonin syndrome.

Epidemiological data have suggested that the use of SSRIs, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn. Data are not available for SNRIs.

Data from animal studies has shown that citalopram may affect sperm quality. Human case reports from some SSRIs have shown this effect to be reversible. As yet, the impact of this on human fertility has not been observed.

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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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: C

Comments:
-Newborns should be monitored if the maternal use of this drug continues into the later stages of pregnancy, particularly the third trimester.
-Abrupt discontinuation should be avoided during pregnancy.

See references

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

Excreted into human milk: Yes

Comments:
-Breastfed infants should be monitored for drowsiness
-Mothers taking an SSRI during pregnancy and postpartum may have difficulty breastfeeding and may require additional breastfeeding support.

Cases of minor behavioral side effects such as drowsiness or fussiness have been reported; however no adverse effects on development have been observed in infants followed for up to 1 year.

It has been suggested that citalopram therapy may be continued during breastfeeding if it was used during pregnancy or if other antidepressants were ineffective. Escitalopram, the S-enantiomer of citalopram, may be preferred during breastfeeding as its usual dose is about 25% that of citalopram and has a lower infant exposure.

One study has reported that the relative dose to a suckling infant is similar to that reported for fluoxetine, and higher than that reported for fluvoxamine, paroxetine, or sertraline.

Two cases have been reported of infants experiencing excessive somnolence, decreased feeding, and weight loss in relation to breast-feeding from a mother receiving citalopram. Milk/serum concentration ratios based on single pairs of samples from the two patients ranged from 1.16 to 1.88. Based on this, the absolute dose a suckling infant may ingest would be in the range of 4.3 to 17.6 micrograms/kg. The relative dose would be 0.7% to 5.9% of the weight- adjusted maternal dose. In one case the infant was reported to have recovered completely once the infants mother discontinued the citalopram.

According to another case report, the relative infant citalopram dose from breast milk is approximately 9% of the weight- adjusted maternal dose.

A study of seven women taking citalopram and their infants has reported that the plasma concentrations of citalopram and demethylcitalopram in the infants were very low or absent and there were no adverse effects.

See references