Question

I am a breastfeeding mother and i want to know if it is safe to use Omeprazole delayed-release? Is Omeprazole delayed-release safe for nursing mother and child? Does Omeprazole delayed-release extracts into breast milk? Does Omeprazole delayed-release has any long term or short term side effects on infants? Can Omeprazole delayed-release influence milk supply or can Omeprazole delayed-release decrease milk supply in lactating mothers?

Omeprazole delayed-release lactation summary

Omeprazole delayed-release is safe in breastfeeding
  • DrLact safety Score for Omeprazole delayed-release is 1 out of 8 which is considered Safe as per our analyses.
  • A safety Score of 1 indicates that usage of Omeprazole delayed-release is mostly safe during lactation for breastfed baby.
  • Our study of different scientific research also indicates that Omeprazole delayed-release does not cause any serious side effects in breastfeeding mothers.
  • Most of scientific studies and research papers declaring usage of Omeprazole delayed-release safe in breastfeeding are based on normal dosage and may not hold true for higher dosage.
  • Score calculated using the DrLact safety Version 1.2 model, this score ranges from 0 to 8 and measures overall safety of drug in lactation. Scores are primarily calculated using publicly available case studies, research papers, other scientific journals and publically available data.

Answer by Dr. Ru: About Omeprazole delayed-release usage in lactation

High plasma protein binding makes excretion into breast milk to be insignificant. No side effects were observed in breastfed infants of treated mothers. Shown to be labile in acid-pH environment must be administered in the form of micro-granules within an enteric-coated capsule. Any small quantity reaching the infant's stomach would be readily inactivated. Hyperprolactinemia and Galactorrhea have been reported.

Answer by DrLact: About Omeprazole delayed-release usage in lactation

Limited information indicates that maternal Omeprazole delayed-release doses of 20 mg daily produce low levels in milk and would not be expected to cause any adverse effects in breastfed infants.

Omeprazole delayed-release Side Effects in Breastfeeding

One mother taking oral Omeprazole delayed-release 20 mg daily pumped and discarded her milk once each day 4 hours after her morning dose. She breastfed her infant the remainder of the day for 3 months before weaning. The infant remained well at 12 months of age.[1]

Omeprazole delayed-release Possible Effects in Breastfeeding

The Spanish pharmacovigilance system found 20 cases of gynecomastia reported during the time period of 1982 to 2006.[2] A 13-year-old girl was placed on Omeprazole delayed-release 20 mg twice daily by mouth for dyspepsia caused by mefenamic acid and a infection. After 2 days of therapy, she developed bilateral galactorrhea and elevated serum prolactin. Three weeks after discontinuing Omeprazole delayed-release, galactorrhea and hyperprolactinemia resolved. Six weeks later, she was rechallenged with Omeprazole delayed-release and her serum prolactin rose from 27 to 70 mcg/L. Prolactin returned to normal 2 weeks after Omeprazole delayed-release discontinuation. Over the next 6 months, she was given domperidone on one occasion and lansoprazole on another. With both drugs, she developed galactorrhea and hyperprolactinemia which returned to normal after drug discontinuation.[3] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.
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