Is Ramipril (Angiotensin-Converting Enzyme inhibitor) safe to use during breastfeeding?

Ramipril During Breastfeeding

Ramipril should not be used during breastfeeding because the FDA drug label explicitly states that multiple doses may produce unpredictable milk concentrations, and safer ACE inhibitor alternatives with established breastfeeding safety data are available. 1

FDA Drug Label Position

• The FDA label for ramipril clearly advises against use in nursing mothers, noting that while a single 10 mg dose resulted in undetectable amounts in breast milk, multiple doses may produce low milk concentrations that cannot be predicted from single-dose studies 1
• This represents the most authoritative source for ramipril specifically, as it is the official regulatory guidance for this medication 1

Safer ACE Inhibitor Alternatives

Switch to enalapril, captopril, benazepril, or quinapril instead of ramipril, as these ACE inhibitors have established safety data during breastfeeding. 2

• The European Society of Cardiology explicitly states that enalapril has been sufficiently tested in breastfeeding women and that maternal use is safe for babies 2
• Enalapril appears in breast milk at very low concentrations and is one of the most studied ACE inhibitors during lactation 2
• During the postpartum period and breastfeeding, enalapril is considered safe with minimal excretion in breast milk 3

Clinical Management Algorithm

If a breastfeeding mother requires ACE inhibitor therapy:

1. Discontinue ramipril immediately based on FDA labeling 1
2. Switch to enalapril as the preferred ACE inhibitor given the strongest guideline-level evidence from the European Society of Cardiology 2
3. Monitor infant weight during the first 4 weeks as an indicator of kidney function 2
4. Exercise particular caution during the infant's first month of life due to theoretical concerns about neonatal hypotension, though risk appears minimal 2

Pharmacokinetic Considerations

• ACE inhibitors with established safety profiles demonstrate very low breast milk excretion, making the likelihood of significant infant exposure small 2
• The systematic review of antihypertensive medications found that ACE inhibitors had low milk-to-plasma ratios and appear to be safe treatments in nursing mothers 4

Common Pitfalls to Avoid

• Do not continue ramipril simply because a single dose showed undetectable levels - the FDA explicitly warns that multiple doses behave differently 1
• Do not unnecessarily discontinue breastfeeding when safer ACE inhibitor alternatives exist 2
• Do not rely on manufacturer labeling alone - pharmaceutical instructions often label medications as contraindicated due to insufficient testing rather than proven harm, but in ramipril's case, the FDA specifically advises against use 2, 1