Risperidone Pregnancy and Breast Feeding Warnings

Risperidone is also known as: Risperdal, Risperdal Consta, Risperdal M-Tab

Overview

If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Risperidone Orally Disintegrating Tablets while you are pregnant. Risperidone Orally Disintegrating Tablets is found in breast milk. Do not breast-feed while taking Risperidone Orally Disintegrating Tablets.

Risperidone Pregnancy Warnings

Risperidone has been assigned to pregnancy category C by the FDA. Animal studies have reported an increase in stillbirths and an increase in pup deaths in the first 4 days of life. There are no controlled data in human pregnancy. One case of agenesis of the corpus callosum has been reported in an infant exposed to risperidone in utero. Risperidone is only recommended for use during pregnancy when benefit outweighs risk. 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.

Two women, 39- years and 30- years of age, are reported to have received a daily dosage of risperidone 4 mg and 6 mg, respectively, prior to and throughout pregnancy. Intensive support was provided throughout each pregnancy to both mother and child with both women delivering healthy infants at term via cesarean section. Both women breast- fed and continued risperidone therapy postpartum. Examinations up to 9- months and 12- months, respectively, failed to reveal developmental abnormalities in either infant.

Risperidone Lactation Warnings

Risperidone and its active 9-hydroxymetabolite are excreted into human milk in small amounts. There are no data on adverse effects in the nursing infant. The amount in human milk was reported to be below the 10% level of concern recommended for safe breast-feeding with many drugs. The amount excreted would not be expected to cause sedation or extrapyramidal side effects in infants who are full-term or older. However, due to the possibility of non-dose related adverse effects such as neuroleptic malignant syndrome and due to the fact that the short and long term effects of risperidone exposure on cognitive development in nursing infants is unknown, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

One case has been reported where the breast milk of a woman receiving risperidone was tested for levels of the drug. The authors calculated that a suckling infant would receive 0.84% of the maternal dose as risperidone and an additional 3.46% from 9-hydroxyrisperidone (as risperidone equivalents). These results were later replicated in 2 additional cases. Two women, 39-years and 30-years of age, are reported to have received a daily dosage of risperidone 4 mg and 6 mg, respectively, prior to, during pregnancy. Both women breast-fed and continued risperidone therapy postpartum. The exact duration of time for which each infant was breast-fed was not disclosed; however, examinations up to 9-months and 12-months, respectively, failed to reveal developmental abnormalities in either infant.

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