Lansoprazole and Breastfeeding

Summary of use during lactation

No information is available on the use of lansoprazole during breastfeeding. However, lansoprazole has been used safely in newborn infants, so it is unlikely that the amount in breastmilk would be harmful.

Drug levels in milk and infant serum

Maternal Levels. Relevant published information was not found as of the revision date. Infant Levels. Relevant published information was not found as of the revision date.

Effects in breastfed infants

Relevant published information was not found as of the revision date.

Effects on lactation and breastmilk

The Spanish pharmacovigilance system found 3 cases of gynecomastia associated with lansoprazole reported during the time period of 1982 to 2006.[1] A retrospective claims database study in the United States found that users of proton pump inhibitors had an increased risk of gynecomastia.[2] A review article reported that a search of database from the European Pharmacovigilance Centre found 45 cases of gynecomastia, 11 cases of galactorrhea, 3 cases of breast pain and 5 cases of breast enlargement associated with lansoprazole. A search of the WHO global pharmacovigilance database found 123 cases of gynecomastia, 30 cases of galactorrhea, 36 cases of breast pain and 18 cases of breast enlargement associated with lansoprazole.[3] In a retrospective study, out of total of 127 cases of gynecomastia in of 175 male patients, 11 patients were treated had been treated with lansoprazole.[4] One case of elevated serum prolactin and galactorrhea was reported in a 21-year-old man. When omeprazole was substituted for lansoprazole, the serum prolactin decreased to the normal range and galactorrhea ceased. Although this case occurred in Spain, it was not included in the report above.[5] A 13-year-old girl with a recent history of bilateral galactorrhea and hyperprolactinemia from omeprazole and domperidone on separate occasions was given lansoprazole to prevent gastrointestinal irritation following intravenous diclofenac for a severe headache. After 3 days of lansoprazole therapy, she again developed galactorrhea and an elevated serum prolactin that returned to normal a week after discontinuing lansoprazole.[6] A 17-year-old woman using a progestin-containing IUD for 1 year began lansoprazole 15 mg daily and presented after 1 week with bilateral galactorrhea and hyperprolactinemia of 92 mcg/L. Seventy-two hours after discontinuation of lansoprazole, galactorrhea ceased. Four months later, serum prolactin was normal at 24.1 mcg/L with no recurrence of galactorrhea. The authors judged the adverse reaction likely to be caused by lansoprazole.[7] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

Alternative drugs to consider

Antacids, Cimetidine, Famotidine, Omeprazole, Pantoprazole, Sucralfate

References

1. Carvajal A, Macias D, Gutierrez A, et al. Gynaecomastia associated with proton pump inhibitors: A case series from the Spanish Pharmacovigilance System. Drug Saf 2007;30:527-31.17536878 PubMed
2. He B, Carleton B, Etminan M. Risk of gynecomastia with users of proton pump inhibitors. Pharmacotherapy 2019;39:614-8.30865318 PubMed
3. Ashfaq M, Haroon MZ, Alkahraman YM. Proton pump inhibitors therapy and risk of hyperprolactinemia with associated sexual disorders. Endocr Regul 2022;56:134-47.35489049 PubMed
4. Daniels IR, Layer GT. How should gynaecomastia be managed? ANZ J Surg 2003;73:213-6. doi:10.1046/j.1445-1433.2002.02584.x12662229 PubMed
5. Izquierdo Prieto OM, Moreno Alia E, Rosillo González A. [Galactorrhea induced by lansoprazole]. Aten Primaria 2004;34:325-6.15491529 PubMed
6. Jabbar A, Khan R, Farrukh SN. Hyperprolactinaemia induced by proton pump inhibitor. J Pak Med Assoc 2010;60:689-90.20726208 PubMed
7. Duwicquet F, Gras-Champel V, Masmoudi K. Hyperprolactinemia with galactorrhea induced by lansoprazole: A case report. Therapie 2017;72:691-3.29061292 PubMed