Paliperidone Pregnancy and Breastfeeding Warnings
Paliperidone 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 this drug is unknown. Animal studies have revealed an increase in stillbirths and an increase in pup deaths in the first 4 days of life. Hyperprolactinemia caused by this drug 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 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 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 this drug during the third trimester should be monitored for extrapyramidal and/or withdrawal symptoms following delivery. -US: The National Pregnancy Registry for Atypical Antipsychotics monitors pregnancy outcomes in women exposed to atypical antipsychotics during pregnancy. Information is available at http://womensmentalhealth.org/ or by phone at 1-866-961-2388.
Paliperidone 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 reactions in nursing infants, other agents may be preferred, especially while nursing a newborn or preterm infant.
Paliperidone is 9-hydroxyrisperidone, the active metabolite of risperidone. Following risperidone administration, 9-hydroxyrisperidone has been measured in milk and plasma. Calculations using an average milk-to-plasma ratio of 0.3 (determined from 3 reports of risperidone use during breastfeeding) suggests an exclusively breastfed infant may expect to receive about 1% of the maternal weight-adjusted dose of paliperidone. Since paliperidone is only available as a sustained-release product, timing of nursing with respect to drug levels will not be helpful. Paliperidone has been detected at very low levels in plasma up to 18 months after a single-dose of the 3-month extended-release product. The clinical significance of that on the breastfed infant is not known.
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