Risperidone Pregnancy and Breastfeeding Warnings
Risperidone Pregnancy Warnings
Agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates exposed to antipsychotics during the third trimester. Cases have varied widely in severity from self-limited cases to reports of neonates who have required intensive support and prolonged hospitalization. One case of agenesis of the corpus callosum has been received in an infant exposed to risperidone in utero, although the relationship to drug is unknown. Animal studies have reported an increase in stillbirths and an increase in pup deaths in the first 4 days of life. Hyperprolactinemia caused by risperidone may impair reproductive function in both male and female patients. Hyperprolactinemia causes a reduction in the pituitary secretion of gonadotropin which, in turn, impairs gonadal steroidogenesis. There is 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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. AU TGA pregnancy category: C US FDA pregnancy category: C Comments: Neonates exposed to drug during the third trimester should be monitored for extrapyramidal and/or withdrawal symptoms following delivery.
Risperidone Breastfeeding Warnings
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes Comments: -Due to lack of published data and the potential for serious adverse reaction in nursing infants, other agents may be preferred, especially while nursing a newborn or preterm infant. -Women should not breastfeed for at least 12 weeks after receiving a long-acting injection of the drug.
An exclusively breastfed infant may expect to receive 4.3% of the maternal weight-adjusted drug dosage. This calculation is based on a study in 1 mother receiving risperidone 6 mg daily and having her milk and serum levels of risperidone and its active metabolite (9-hydroxyrisperidone) measured over 24 hours.
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