Clozapine Pregnancy and Breastfeeding Warnings

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

Clozapine Pregnancy Warnings

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. 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. FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no controlled studies in pregnant women.

FDA pregnancy category: B Potential benefit should outweigh the potential risk.

Clozapine Breastfeeding Warnings

A single case report has suggested that clozapine is excreted into human breast milk and achieves milk levels which are 2 to 3 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.

Use of clozapine should be avoided. Excreted into human milk: Yes Excreted into animal milk: Unknown The effects in the nursing infant are unknown.

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