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Esomeprazole / naproxen Pregnancy and Breastfeeding Warnings

Esomeprazole / naproxen is also known as: Vimovo

Esomeprazole / naproxen Pregnancy Warnings

Esomeprazole-naproxen has been assigned by the FDA to pregnancy category C prior to 30 weeks gestation then category D starting at 30 weeks gestation. Animal studies have revealed evidence of fetal harm. There are no controlled data in human pregnancy. Esomeprazole-naproxen is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Starting at 30 weeks gestation, naproxen, and other NSAIDs, should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur. Naproxen can cause fetal harm when administered to a pregnant woman starting at 30 weeks gestation. If this drug is used during this time period in pregnancy, the patient should be apprised of the potential hazard to a fetus.

Esomeprazole / naproxen Breastfeeding Warnings

There are no data on the excretion of esomeprazole into human milk. The naproxen anion has been found in the milk of lactating women at a concentration equivalent to approximately 1% of maximum naproxen concentration in plasma. There are possible adverse effects of prostaglandin-inhibiting drugs on neonates. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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