RiteMED Risperidone Use In Pregnancy & Lactation

Pregnancy: Pregnancy Category C.
Adequate and well controlled studies with risperidone have not been conducted in pregnant women. Neonates exposed to antipsychotic drugs, including risperidone, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.
Neonates exposed to antipsychotic drugs, including risperidone, during the third trimester of pregnancy are at risk of experiencing extrapyramidal neurological disturbances and/or withdrawal symptoms following delivery. Monitor neonates exhibiting extrapyramidal or withdrawal symptoms. Some neonates recover within hours or days without specific treatment; others may require prolonged hospitalization.
There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder in neonates following in utero exposure to antipsychotics in the third trimester. 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. There was one report of a case of agenesis of the corpus callosum in an infant exposed to risperidone in utero. The causal relationship to risperidone therapy is unknown.
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 in unknown.
Lactation: Risperidone and 9-hydroxyrisperidone are present in human breast milk. Due to the potential for serious adverse reactions in breastfeeding infants from risperidone, a decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother.
Fertility: As with other drugs that antagonize dopamine D2 receptors, risperidone elevates prolactin level. Hyperprolactinemia may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotropin secretion. This, in turn, may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients.