Omeprazole Pregnancy and Breast Feeding Warnings
Omeprazole is also known as: Prilosec, Prilosec OTC, Zegerid (Original Formulation)
Overview
If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Omeprazole Delayed-Release Tablets while you are pregnant. Omeprazole Delayed-Release Tablets is found in breast milk. Do not breast-feed while taking Omeprazole Delayed-Release Tablets.
Omeprazole Pregnancy Warnings
Omeprazole has been assigned to pregnancy category C by the FDA. Some animal studies have revealed evidence of embryolethality and fetotoxicity. There are no controlled data in human pregnancy. Omeprazole has been used during labor and delivery to prevent Mendelson's syndrome. Omeprazole should only be given during pregnancy when benefit outweighs risk.
Data pertaining to the use of omeprazole during pregnancy are limited. In one study, omeprazole 80 mg was administered orally one time to prevent Mendelson's syndrome in 20 women with uncomplicated pregnancies of at least 36 weeks duration (mean, 38.3 weeks) requiring scheduled Cesarean section. Cesarean section was done approximately 13 to 16 hours after the dose. Omeprazole was undetectable (<20 nmol/l) in umbilical vein samples from 16/20 infants. Omeprazole was undetectable in umbilical artery samples from 10/17 infants. There were no apparent adverse effects in the neonates.
Omeprazole Lactation Warnings
There are no data on the excretion of omeprazole into human milk. Sporadic reports have been received of congenital abnormalities occurring in infants born to women who have received omeprazole during pregnancy. 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 he importance of the drug to the mother.
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