Esidep Use In Pregnancy & Lactation

Use in Pregnancy: Pregnancy Category C: Oral administration of escitalopram (56, 112, or 150 mg/kg/day) to pregnant rats during the period of organogenesis resulted in decreased fetal body weight and associated delays in ossification at the two higher doses (approximately ≥ 56 times the maximum recommended human dose [MRHD] of 20 mg/day on a body surface area [mg/m²] basis). Maternal toxicity (clinical signs and decreased body weight gain and food consumption), mild at 56 mg/kg/day, was reported at all dose levels. The developmental no-effect dose of 56 mg/kg/day is approximately 28 times the MRHD on a mg/m² basis. No teratogenicity has been reported at any of the doses (as high as 75 times the MRHD on a mg/m² basis).
Slightly increased offspring mortality and growth retardation has been reported in pregnant rats at 48 mg/kg/day which is approximately 24 times the MRHD on a mg/m² basis. Slight maternal toxicity (clinical signs and decreased body weight gain and food consumption) has been reported at this dose. Slightly increased offspring mortality was also reported at 24 mg/kg/day. The no-effect dose was 12 mg/kg/day which is approximately 6 times the MRHD on a mg/m² basis.
Racemic citalopram has been shown to have adverse effects on embryo/fetal and postnatal development, including teratogenic effects, in pregnant rats at doses greater than human therapeutic doses.
Oral administration of racemic citalopram (32, 56, or 112 mg/kg/day) to pregnant rats during the period of organogenesis resulted in decreased embryo/fetal growth and survival and an increased incidence of fetal abnormalities (including cardiovascular and skeletal defects) at the high dose. This dose was also associated with maternal toxicity (clinical signs, decreased body weight gain). The developmental no-effect dose was 56 mg/kg/day. Also no adverse effects on embryo/fetal development have been reported in pregnant rabbits at doses of racemic citalopram of up to 16 mg/kg/day. Thus, teratogenic effects of racemic citalopram were reported at a maternally toxic dose in the rat and were not reported in the rabbit.
When female rats were treated with racemic citalopram (4.8, 12.8, or 32 mg/kg/day) from late gestation through weaning, increased offspring mortality during the first 4 days after birth and persistent offspring growth retardation were reported at the highest dose. The no-effect dose was 12.8 mg/kg/day. Similar effects on offspring mortality and growth have been reported in dams receiving escitalopram throughout gestation and early lactation at doses ≥ 24 mg/kg/day. A no-effect dose has not been reported.
There are no adequate and well-controlled reported studies in pregnant women; therefore, escitalopram should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pregnancy-Nonteratogenic Effects: Neonates exposed to escitalopram and other SSRIs or SNRIs, late in the third trimester, have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome (see Precautions).
Infants exposed to SSRIs in late pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). The reported risk was approximately 5 cases per 1000 pregnancies. PPHN occurs in 1-2 per 1000 live births in the general population and is associated with substantial neonatal morbidity and mortality.
When treating a pregnant woman with escitalopram during the third trimester, the physician should carefully consider both the potential risks and benefits of treatment (see Dosage & Administration).
Physicians should note that in women with a history of major depression who are euthymic at the beginning of pregnancy, women who discontinue antidepressant medication during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressant medication.
Labor and Delivery: The effect of escitalopram on labor and delivery in humans is unknown.
Use in Lactation: Like racemic citalopram, escitalopram is distributed in human breast milk. Potential for serious adverse effects (e.g., excessive somnolence, decreased feeding, weight loss) in nursing infants exists. Discontinue nursing or the drug, taking into account the potential risk in nursing infants and the importance of the drug to the mother.