6 Interactions found for:

The following applies to the ingredients: Escitalopram (found in Lexapro)

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.

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 yet, the impact of this on human fertility has not been observed.

To monitor the outcomes of pregnant women exposed to antidepressants, 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 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.

The following applies to the ingredients: Omeprazole

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

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

Risk Summary: Epidemiologic studies have demonstrated that major malformative risks with use in pregnant patients are unlikely.

Comment: Some experts recommend that use is considered acceptable.

Animal models have revealed evidence of dose-related increases in embryolethality, fetal resorptions, and pregnancy disruptions when animal models were given this drug during organogenesis. Major fetal malformations were not frequently observed in animal models. Embryofetal and postnatal developmental toxicities were observed in offspring of parents given at least 3.4 times an oral human dose of 40 mg.

Embryofetal toxicity is associated with maternally toxic doses given throughout gestation as well as in high doses given to males prior to mating.

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.

The following applies to the ingredients: Omeprazole

Use is not recommended.

Excreted into human milk: Yes

Comments:
-This drug is associated with tumorigenicity in animal models, and may suppress gastric acid secretion in the nursing infant.
-The American Academy of Pediatrics state that this drug should be avoided until additional studies can confirm the safe use of this drug during breastfeeding.

In animal models, decreased postpartum offspring growth rates were observed when this drug was administered during late gestation and throughout lactation at oral doses of at least 138 mg/kg/day and IV doses of 3.2 mg/kg/day.

The following applies to the ingredients: Escitalopram (found in Lexapro)

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.