Is Esomeprazole safe while breastfeeding?
Here is what NIH LactMed, the U.S. National Library of Medicine's authority on medicines and breastfeeding, reports about Esomeprazole. This is a summary of that source — not our own verdict.
Effects on the breastfed infant
One mother taking omeprazole 20 mg daily orally 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.[ 2 ] A woman with rheumatoid arthritis was treated with oral esomeprazole 10 mg, prednisone 2.5 mg and sulfasalazine 1 gram once daily as well as injections of certolizumab pegol 200 mg every 2 weeks. Her infant was about 50% breastfed and 50% formula fed. The infant had no detectable drug-related adverse effects.[ 1 ]
Effects on milk supply
Omeprazole (the racemic form) has been reported to cause gynecomastia in several men and a retrospective claims database study in the United States found that users of proton pump inhibitors had an increased risk of gynecomastia.[ 3 , 4 ] A review article reported that a search of database from the European Pharmacovigilance Centre found 45 cases of gynecomastia, 9 cases of galactorrhea, 19 cases of breast pain and 12 cases of breast enlargement associated with esomeprazole. A search of the WHO global pharmacovigilance database found 114 cases of gynecomastia, 38 cases of galactorrhea, 56 cases of breast pain and 28 cases of breast enlargement associated with esomeprazole.[ 5 ] One woman developed elevated serum prolactin and estradiol with bilateral galactorrhea one week after starting esomeprazole 40 mg once daily for reflux esophagitis. The galactorrhea disappeared 3 days after discontinuing esomeprazole and prolactin and estradiol returned to normal 7 days after discontinuation. One month later, the patient restarted esomeprazole and again developed bilateral galactorrhea. She was switched to lansoprazole with no galactorrhea developing.[ 6 ] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.
Levels in milk
Maternal Levels. A woman with rheumatoid arthritis was treated with oral esomeprazole 10 mg (0.17 mg/kg), prednisone 2.5 mg and sulfasalazine 1 gram once daily as well as injections of certolizumab pegol 200 mg every 2 weeks. Milk samples were measured several times during the first 4 days postpartum at 0.7, 4, and 8.2 hours after various doses, milk levels were 10.5 mcg/L, 19.6 mcg/L and 3 mcg/L, respectively. At 8, 10.5 and 19.4 hours after various doses, the drug was undetectable ( 0.1 mcg/L) in milk. Using the highest measured level of 19.6 mcg/L, the authors calculated that a fully breastfed infant would receive a dose of 0.003 mg/kg daily, which would result in a maximum weight-adjusted dose of 1.8% of the mothers dose.[ 1 ] Infant Levels. A woman with rheumatoid arthritis was treated with oral esomeprazole 10 mg (0.17 mg/kg) once daily. Her infant was about 50% breastfed and 50% formula fed. At 12.5 hours after the dose on the day of the infant s birth, the cord blood level was 14.8 mcg/L, representing placental passage. By 23.2 hours after the mother s previous dose (12 hours postpartum), esomeprazole was undetectable ( 0.1 mcg/L) in the infant s serum.[ 1 ]
Alternatives LactMed lists
Source: NIH LactMed (National Library of Medicine).
Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.