Escitalopram Pregnancy and Breastfeeding Warnings

Brand names: Lexapro

Escitalopram Pregnancy Warnings

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.

Risk summary: Based on findings from animal studies, this drug may cause fetal harm when administered to a pregnant patient.

Comments:
-A pregnancy exposure registry is available.
-Neonates exposed to this drug late in the third trimester may require respiratory support, tube feeding, and/or prolonged hospitalization.
-Exposed neonates should be monitored after delivery for direct toxic effects of this drug, drug discontinuation syndrome, and serotonin syndrome (e.g., respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypo/hypertonia, hyperreflexia, tremor, jitteriness, irritability, constant crying).

Animal studies have revealed evidence of embryotoxicity (e.g., reduced fetal weight and reversible delay of ossification), offspring mortality, and delayed growth. Animal studies with racemic citalopram have revealed evidence of teratogenicity at doses greater than human therapeutic doses. There are no controlled data in human pregnancy. Human spontaneous abortion has been reported with racemic citalopram.

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

To monitor the outcomes of pregnant patients exposed to antidepressants, a National Pregnancy Registry for Antidepressants has been established. Physicians are encouraged to register patients and pregnant patients are encouraged to register themselves. 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 decision and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Escitalopram Breastfeeding Warnings

Use with caution; the benefit to the mother should outweigh the risk to the infant.

Excreted into human milk: Yes

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

Escitalopram is not expected to cause adverse effects in breastfed infants, particularly in infants over 2 months of age. One case of necrotizing enterocolitis has been reported in a breastfed newborn whose mother was taking escitalopram during pregnancy and lactation; however, causality was not established.

Maternal doses of escitalopram up to 20 mg per day lead to low levels in milk, approximately 3.9% and 1.7% of the maternal weight-adjusted dose of escitalopram and desmethylcitalopram, respectively. Limited data suggest that escitalopram is preferable to racemic citalopram during breastfeeding due to lower dosage and milk levels, and general lack of side effects in breastfed infants.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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