Renuvie Use In Pregnancy & Lactation

Use in Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. However, there was one case of agenesis of the corpus callosum in an infant exposed to risperidone in utero. The causal relationship to risperidone therapy is unknown.
Neonates exposed to antipsychotic drugs (including risperidone) during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms after 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.
Risperidone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Labor and Delivery: The effect of risperidone on labor and delivery in humans is unknown.
Use in Lactation: Risperidone and 9-hydroxyrisperidone are excreted in human breast milk. Therefore, women receiving risperidone should not breastfeed.