Serrapeptase Safety During Breastfeeding
Serrapeptase should be avoided during breastfeeding due to insufficient safety data, and you should consult a healthcare professional before use if breastfeeding. 1
Primary Recommendation
The FDA-approved labeling for serrapeptase explicitly states: "If pregnant or breastfeeding, ask a healthcare professional before use." 1 This cautionary statement reflects the lack of established safety data for this enzyme during lactation.
Evidence Quality and Gaps
No clinical safety data exists for serrapeptase use during breastfeeding—there are no published studies examining its excretion into breast milk, infant exposure levels, or effects on breastfed infants. 2
The existing evidence for serrapeptase efficacy and safety is insufficient even for general clinical use, with poor methodology in available studies, small sample sizes, and lacking long-term safety data. 2
When medications have insufficient data rather than evidence of harm, the standard approach is to avoid them in breastfeeding women and consider alternative drugs. 3
Clinical Decision Framework
Key principles for medication use during breastfeeding:
The fundamental principle is weighing risk versus benefit—the potential risk of drug therapy must be balanced against the risk of untreated maternal symptoms. 4, 5
Preference should be given to medications with established safety profiles during lactation, particularly those that have been studied and show minimal transfer to breast milk. 6, 7
Drugs with a relative infant dose <10% of the maternal dose are considered preferred options. 8
Practical Considerations
No established therapeutic necessity: Serrapeptase is promoted as an anti-inflammatory and analgesic agent, but evidence-based alternatives with known safety profiles during breastfeeding exist (such as ibuprofen or acetaminophen). 6
Monitor infants for unusual symptoms including changes in stool pattern, irritability, or poor feeding if any medication is used during breastfeeding. 8
Alternative approaches: For inflammation or pain management during breastfeeding, consider well-studied medications like acetaminophen or ibuprofen, which are preferred analgesics with established safety. 6
Common Pitfalls to Avoid
Do not assume that supplements or enzymes are automatically safe during breastfeeding—herbal supplements and novel agents pose particular concern due to lack of study effects on breastfed infants and risk of impurities. 6
Avoid discouraging breastfeeding unnecessarily, but equally important is avoiding medications without established safety data when safer alternatives exist. 4