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Clozapine Pregnancy and Breastfeeding Warnings

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

Clozapine Pregnancy Warnings

There have been reports of extrapyramidal and withdrawal symptoms in neonates exposed to antipsychotic drugs during the third trimester of pregnancy. These complications have varied in severity, from self-limited to needing intensive care unit support and prolonged hospitalization. Animal studies in rats and rabbits at doses up to 0.4 and 0.9 times the maximum recommended human doses, respectively, have revealed no evidence of impaired fertility or harm to the fetus. Clinically, there is a risk of exacerbation of psychosis when discontinuing or changing antipsychotic therapy. There are no controlled data in human pregnancy. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Use only if clearly needed and only if the anticipated benefit to the mother outweighs the risk to the fetus. AU TGA pregnancy category: C US FDA pregnancy category: B Comments: -Monitor neonates that have been exposed to antipsychotic drugs during the third trimester of pregnancy for symptoms of agitation, hypertonia, tremor, somnolence, respiratory distress, and feeding difficulties. -Women receiving antipsychotic medication during pregnancy should consider undergoing early screening for gestational diabetes.

Clozapine Breastfeeding Warnings

There is limited data regarding use of this drug during breastfeeding. Because sedation and adverse hematologic effects have been reported, other agents are preferred. In 4 breastfed infants, 1 experienced sedation and 1 agranulocytosis; specific details of these cases are not available.

Use should be avoided; discontinue drug or discontinue nursing taking into consideration importance of drug to mother. Excreted into human milk: Yes Comments: If breastfeeding is undertaken, closely monitor breastfed infant for excessive sedation and periodically monitor WBC.

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