Esomeprazole Pregnancy and Breastfeeding Warnings

Esomeprazole is also known as: Nexium, Nexium 24HR, Nexium IV

Esomeprazole Pregnancy Warnings

FDA pregnancy category: C (esomeprazole strontium); B (esomeprazole magnesium) Use esomeprazole strontium only if the potential benefit outweighs the risk to the developing fetus. Use esomeprazole magnesium only if clearly needed.

Animal studies have failed to reveal evidence of teratogenicity or fetal harm at therapeutic doses. However, doses of 5.5 to 56 times the human dose on a body surface area basis have produced dose-related embryolethality and fetal resorption. In addition, changes in bone morphology and physeal dysplasia were observed in pre- and postnatal developmental toxicity animal studies at doses approximately 33.6 times the daily maximum recommended human dose (MRHD). There are no controlled data in human pregnancy. Animal studies with esomeprazole magnesium revealed changes in bone morphology in offspring of rats dosed through most of the pregnancy and lactation with doses equal to or greater than approximately 33.6 times an oral human dose of 40 mg. FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Esomeprazole Breastfeeding Warnings

The potential for tumorigenicity with esomeprazole administration has been illustrated in rat carcinogenicity studies, as well as, the effects of high doses of esomeprazole strontium on developing bone in rat studies.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes (esomeprazole); Yes (strontium) Excreted into animal milk: Yes The effects in the nursing infant are unknown.

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