Esomeprazole Pregnancy and Breastfeeding Warnings
Esomeprazole Pregnancy Warnings
US: This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. AU: This drug should be used only if clearly needed. UK: Caution is recommended. AU TGA pregnancy category: B3 US FDA pregnancy category: C
Animal studies have failed to reveal evidence of teratogenicity or fetal harm at therapeutic doses. However, changes in bone morphology were observed in offspring of rats, dosed through most of the pregnancy and lactation, at doses equal to or greater than 33.6 times an oral human dose of 40 mg. There are no controlled data in human pregnancy. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US 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
Esomeprazole is the S-isomer of omeprazole and limited data indicate that maternal doses of omeprazole 20 mg daily produce low levels in human milk. No studies in lactating women have been performed. Esomeprazole strontium: Studies showed effects of esomeprazole strontium on developing bone in rats, at high doses.
AU, UK: Use is not recommended. US: Caution is recommended. Esomeprazole Strontium: US: A decision should be made to discontinue breastfeeding or discontinue this drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant are unknown.
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