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Duloxetine Pregnancy and Breastfeeding Warnings

Duloxetine is also known as: Cymbalta

Duloxetine Pregnancy Warnings

The physician may wish to consider tapering duloxetine in the third trimester.

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.

Duloxetine Breastfeeding 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. Lilly maintains a pregnancy registry to monitor the pregnancy outcomes of women exposed to Cymbalta while pregnant. Healthcare providers are encouraged to register any patient who is exposed to Cymbalta during pregnancy by calling the Cymbalta Pregnancy Registry at 1-866-814-6975 or by visiting www.cymbaltapregnancyregistry.com

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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