pms-Risperidone Use In Pregnancy & Lactation





Full Prescribing Info
Use In Pregnancy & Lactation
Pregnant Women: Teratogenic Effects: The safety of risperidone during pregnancy has not been established. A retrospective observational cohort study based on a US claims database compared the risk of congenital malformations for live births among women with and without antipsychotic use during the first trimester of pregnancy. Compared to no antipsychotic exposure, the relative risk of congenital malformations with risperidone, after adjusting for confounder variables available in the database, was statistically significant (relative risk = 1.26, 95% CI: 1.02-1.56). No biological mechanism has been identified to explain these findings and teratogenic effects have not been observed in non-clinical studies. Based on the findings of this single observational study, a causal relationship between in utero exposure to risperidone and congenital malformations has not been established.
In animal studies, risperidone did not show direct reproductive toxicity. However, due to its prolactin-elevating and CNS-depressant activities, reproductive performance and pup survival were adversely affected in rats. Risperidone was not teratogenic in either rats or rabbits.
Placental transfer of risperidone occurs in rat pups. There are no adequate and well-controlled studies in pregnant women. However, 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 (see Pharmacology: Toxicology: Reproductive and Developmental Toxicology under Actions).
Non-Teratogenic Effects: Neonates exposed to antipsychotic drugs (including risperidone) during the third trimester of pregnancy are at risk of 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.
pms-RISPERIDONE should not be used during pregnancy unless the expected benefits to the mother markedly outweigh the potential risks to the fetus.
Nursing Women: Risperidone appeared in the milk of lactating dogs. The concentration of risperidone was similar in milk and plasma, while that of 9-hydroxyrisperidone was higher in the milk than in plasma. It has been demonstrated that risperidone and 9-hydroxyrisperidone are also excreted in human breast milk.
Nursing should not be undertaken while a patient is receiving pms-RISPERIDONE.
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