Clozapine Pregnancy and Breast Feeding Warnings

Clozapine is also known as: Clopine, Clozapine Synthon, Clozaril, Denzapine, FazaClo, Zaponex

Overview

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

Clozapine Pregnancy Warnings

Clozapine has been assigned to pregnancy category B by the FDA. High dose animal studies have failed to reveal evidence of specific teratogenic effects. There are no controlled data in human pregnancy. Clozapine is only recommended for use during pregnancy when need is clearly established and when benefit outweighs risk.

As of December, 1990, at least 14 women were known to have been exposed to clozapine during pregnancy. No adverse effects have been reported in the offspring of those pregnancies.

Clozapine Lactation Warnings

Clozapine is excreted into human milk. The effects in the nursing infant are unknown. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

A single case report has suggested that clozapine is excreted into human breast milk and achieves milk levels which are two to three times maternal plasma levels. The clinical implications in breast-fed infants is unknown. The authors of the case report however, suggest that breast-feeding be avoided if possible in women taking clozapine.

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