Is serratiopeptidase safe to use during breastfeeding?

Serratiopeptidase During Breastfeeding

Serratiopeptidase should be avoided during breastfeeding due to insufficient safety data, and alternative medications with established safety profiles should be used instead.

Evidence-Based Rationale

The FDA drug label explicitly states: "If pregnant or breastfeeding, ask a healthcare professional before use," indicating lack of established safety data 1. This aligns with the standard guideline approach that when medications have insufficient data rather than evidence of harm, the recommendation is to avoid them in breastfeeding women and consider alternative drugs 2.

Why This Recommendation Matters

• No published data exists on serratiopeptidase excretion into breast milk, infant exposure levels, or effects on breastfed infants 3
• The enzyme's proteinaceous nature and pharmacokinetic properties have not been studied in the lactation context 4
• Guideline consensus across multiple specialties (rheumatology, gastroenterology, hematology) consistently recommends avoiding medications with limited or no breastfeeding data when alternatives exist 2

Clinical Decision Framework

Step 1: Assess Medical Necessity

• Determine if serratiopeptidase is being used for anti-inflammatory, anti-edema, or analgesic purposes 3
• The existing scientific evidence for serratiopeptidase is insufficient to support its use as an analgesic, with most clinical studies having poor methodology and small sample sizes 3

Step 2: Consider Safer Alternatives

• For pain and inflammation: Ibuprofen and paracetamol are considered safe during breastfeeding with established compatibility 2
• For anti-inflammatory needs: NSAIDs have well-documented safety profiles in lactation 2
• For postoperative inflammation: Short courses of corticosteroids are found in low concentrations in breast milk and are compatible with breastfeeding 2

Step 3: Apply Risk-Benefit Analysis

• The fundamental principle is weighing the risk of drug therapy against the risk of untreated maternal symptoms 5
• Given serratiopeptidase's questionable clinical efficacy and lack of safety data, the risk-benefit ratio does not favor its use 3
• Preference should be given to medications with established safety profiles, particularly those showing minimal transfer to breast milk with relative infant dose <10% of maternal dose 5

Important Caveats

• Long-term safety data for serratiopeptidase is completely lacking, even in non-breastfeeding populations 3
• The dose and duration of treatment have not been well-specified in existing clinical studies 3
• If a breastfeeding woman has already taken serratiopeptidase, monitor the infant for unusual symptoms including changes in stool pattern, irritability, or poor feeding 5

What Not to Do

• Do not assume safety based on widespread use—serratiopeptidase is promoted as a health supplement despite insufficient evidence 3
• Do not discontinue breastfeeding unnecessarily—breastfeeding has significant benefits for both mother and infant and should continue with appropriate medication selection 2
• Do not use serratiopeptidase when evidence-based alternatives with known safety profiles are available 2, 5