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Clozapine Pregnancy and Breastfeeding 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 taking Clozapine while you are pregnant. Using Clozapine during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. It is not known if Clozapine is found in breast milk. Do not breast-feed while taking Clozapine.

Clozapine Pregnancy Warnings

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 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. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. Clozapine is only recommended for use during pregnancy when benefit outweighs risk.

Clozapine Breastfeeding Warnings

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.

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.

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