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Paliperidone Pregnancy and Breastfeeding Warnings

Paliperidone is also known as: Invega, Invega Sustenna

Overview

If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Paliperidone Extended-Release Tablets while you are pregnant. Taking Paliperidone Extended-Release Tablets during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. Paliperidone Extended-Release Tablets are found in breast milk. If you are or will be breast-feeding while you take Paliperidone Extended-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Paliperidone Pregnancy Warnings

Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with paliperidone. The extrapyramidal symptoms are usually self-limited. It is not known whether paliperidone, when taken near the end of pregnancy, will lead to similar neonatal signs and symptoms.

Paliperidone has been assigned to pregnancy category C by the FDA. Animal studies have revealed increased pre and post implantation loss, a slightly decreased number of live embryos, and decreases in serum testosterone, sperm motility and sperm concentration. There are no controlled data in human pregnancy. Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for 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. Paliperidone is only recommended for use during pregnancy when there are no and benefit outweighs risk.

Paliperidone Breastfeeding Warnings

Paliperidone is excreted into human milk. The manufacturer recommends that patients should be advised not to breast-feed an infant if they are taking paliperidone.

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