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Clomipramine Pregnancy and Breastfeeding Warnings

Clomipramine is also known as: Anafranil

Overview

It is not known if Clomipramine can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Clomipramine while you are pregnant. Clomipramine is found in breast milk. Do not breast-feed while taking Clomipramine.

Clomipramine Pregnancy Warnings

Clomipramine has been assigned to pregnancy category C by the FDA. Animal studies have reported an increase in nonspecific fetotoxic effects at doses 10 times the normal human dose. In humans, both withdrawal symptoms and clomipramine toxicity have been reported in neonates whose mothers took the drug during pregnancy. Specifically, respiratory distress, tachypnea, cyanosis, hypothermia, lethargy, tremor, hypotonia, diaphoresis, jitteriness, and seizures have been reported in exposed neonates. Clomipramine should only be given in pregnancy when no alternatives exist.

Clomipramine Breastfeeding Warnings

Four breast-fed infants of clomipramine treated mothers (75 to 125 mg/day) were reported to have had serum concentrations below the assay sensitivity level for the three metabolites of clomipramine. All four infants were described as developing normally.

Clomipramine is excreted into human milk in small amounts. One case report has suggested that clomipramine plasma concentrations in the breast-fed infant are about 6% those of maternal levels. No adverse effects were noted in that infant. Clomipramine is considered compatible with breast-feeding by the American Academy of Pediatrics.

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