Duloxetine Pregnancy and Breast Feeding Warnings
Duloxetine is also known as: Cymbalta
Overview
Duloxetine Delayed-Release Capsules may cause harm to the fetus if it is used during the last 3 months of pregnancy. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Duloxetine Delayed-Release Capsules while you are pregnant. Duloxetine Delayed-Release Capsules is found in breast milk. Do not breast-feed while taking Duloxetine Delayed-Release Capsules.
Duloxetine Pregnancy Warnings
Duloxetine has been assigned to pregnancy category C by the FDA. Neonates exposed to SSRIs and SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. (Such complications can arise immediately upon delivery.) Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. (These features are consistent with either a direct toxic effect of SSRIs and SNRIs, or possibly a drug discontinuation syndrome.) In some cases, the clinical picture is consistent with serotonin syndrome. Animal studies on duloxetine have revealed evidence of adverse effects on embryo/fetal and postnatal development. There are no controlled data in human pregnancy. Duloxetine should be given during pregnancy and particularly during the third trimester, only if the potential benefits outweigh the potential risks to the fetus.
The physician may wish to consider tapering duloxetine in the third trimester.
Duloxetine Lactation Warnings
Duloxetine is excreted into human milk. The effects in the nursing infant are unknown. According to the manufacturer, breast-feeding is not recommended during administration of duloxetine.
In lactating women receiving duloxetine, the daily infant dose, on a mg per kg basis, is estimated at approximately 0.14% of the maternal dose. Duloxetine and/or its metabolites are excreted into the milk of lactating rats.
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