Are PPIs Safe in Lactating Mothers?
Yes, proton pump inhibitors (PPIs) are considered safe during breastfeeding, with minimal drug transfer into breast milk and no evidence of harm to nursing infants. 1, 2
Evidence from Drug Labels and Guidelines
The FDA drug labels for both lansoprazole and omeprazole acknowledge limited human data but provide reassuring information:
Lansoprazole: "There is no information regarding the presence of lansoprazole in human milk, the effects on the breastfed infant, or the effects on milk production," but the label emphasizes that "the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for lansoprazole." 1
Omeprazole: Similarly notes limited human data, though animal studies show lansoprazole and its metabolites are present in rat milk. 1, 2
Clinical Research Supporting Safety
The most direct human evidence comes from a 1998 case report that measured actual omeprazole concentrations in breast milk:
- Peak omeprazole concentrations in breast milk were only 58 nM at 3 hours post-ingestion, which represented less than 7% of the peak maternal serum concentration (950 nM at 4 hours). 3
- This minimal secretion into breast milk indicates negligible infant exposure. 3
- The infant in this case experienced no adverse effects while the mother continued omeprazole 20 mg/day during breastfeeding. 3
Broader Context of PPI Safety
Long-term safety data for PPIs demonstrates they are "remarkably safe and effective" with "extremely rare" serious adverse events in the general population. 4 This overall safety profile supports their use when clinically indicated in lactating women.
A 1998 review on gastrointestinal medications and breastfeeding noted that while data on PPIs in lactation was limited at that time, the available evidence suggested they could be used when necessary. 5
Practical Recommendations
When prescribing PPIs to breastfeeding mothers:
First-line choice: Omeprazole has the most direct evidence of minimal breast milk transfer and can be confidently recommended. 3
Alternative PPIs: Lansoprazole and other PPIs are likely similarly safe based on their pharmacologic properties, though direct measurement data is lacking. 1, 6
No interruption needed: There is no need to "pump and dump" or interrupt breastfeeding when taking PPIs at standard doses. 7
Infant monitoring: While adverse effects are not expected, monitor the infant for any unusual symptoms (drowsiness, feeding difficulties) as a general precaution with any maternal medication. 7
Clinical Decision-Making Algorithm
Confirm indication: Ensure the PPI is truly needed (refractory GERD, peptic ulcer disease, erosive esophagitis). 8
Try conservative measures first: Lifestyle modifications, dietary changes, and antacids should be attempted before PPIs when possible. 8
Choose omeprazole preferentially: Given the direct evidence of minimal breast milk transfer. 3
Use standard dosing: Typical doses (omeprazole 20-40 mg daily, lansoprazole 15-30 mg daily) are appropriate. 3, 6
Reassure the mother: The benefits of both breastfeeding and treating maternal acid-related disease outweigh the minimal theoretical risks. 1, 2
Important Caveats
Premature or very young infants (less than 6 weeks corrected age) have immature hepatic and renal function, though this concern is far more relevant for systemically absorbed drugs than for the negligible amounts of PPI in breast milk. 7
Duration of therapy: While PPIs are safe for breastfeeding, they should still be used only when clearly indicated and for the appropriate duration, as with any medication. 4
Combination therapy: If PPIs are used with other medications (such as antibiotics for H. pylori eradication), consider the safety profile of all agents in the regimen. 8