Lansoprazole Use During Breastfeeding
Lansoprazole can be used during breastfeeding, as there is no evidence of harm to the infant, though data are limited and the drug's presence in human milk is unknown. 1
FDA-Approved Labeling Position
The FDA drug label for lansoprazole explicitly states that there is no information regarding the presence of lansoprazole in human milk, the effects on the breastfed infant, or the effects on milk production. 1 However, the label emphasizes that the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for lansoprazole and any potential adverse effects on the breastfed child. 1
Evidence from Related Proton Pump Inhibitors
While direct data on lansoprazole in breast milk are lacking, evidence from omeprazole (a closely related PPI) provides reassuring information:
- Peak omeprazole concentrations in breast milk were less than 7% of peak serum concentration (58 nM at 3 hours versus 950 nM at 4 hours), indicating minimal secretion into breast milk. 2
- A breastfeeding mother taking omeprazole 20 mg/day showed no adverse effects in her infant. 2
Clinical Decision-Making Framework
When medications have insufficient data rather than evidence of harm, the standard approach weighs the risk of drug therapy against the risk of untreated maternal symptoms. 3
Key Considerations:
- Most medications are compatible with breastfeeding, and only a few are absolutely contraindicated (antineoplastics, radiopharmaceuticals, drugs of abuse). 4
- Women should not be discouraged from breastfeeding while taking compatible medications, given the substantial benefits of breastfeeding for both infant and maternal health. 5
- Preference should be given to medications with established safety profiles during lactation, particularly those showing minimal transfer to breast milk with a relative infant dose <10% of the maternal dose. 3
Practical Recommendations
If lansoprazole is clinically necessary for the mother:
- Continue breastfeeding while monitoring the infant for unusual symptoms, including changes in stool pattern, irritability, or poor feeding. 3
- Consider timing doses immediately after breastfeeding to minimize infant exposure (though this is theoretical given unknown milk levels). 6
- Use the lowest effective dose for the shortest duration necessary. 4
Important Caveats
- All medications are excreted into breast milk to some extent, with the amount depending on drug characteristics, maternal pharmacokinetics, and dosing. 6
- Clear, safe, and reliable information is still lacking for most drugs during lactation, including lansoprazole specifically. 7
- The decision should involve shared decision-making between clinician and patient, balancing maternal therapeutic need against theoretical infant risk. 1, 4