Serratiopeptidase Safety During Pregnancy
Serratiopeptidase should not be used during pregnancy due to insufficient safety data, and pregnant women should consult a healthcare professional before use, as explicitly stated in the FDA labeling. 1
Evidence Base and Regulatory Guidance
The FDA drug label for serratiopeptidase specifically warns: "If pregnant or breastfeeding, ask a healthcare professional before use." 1 This cautionary statement reflects the complete absence of controlled safety studies in pregnant women.
Critical Evidence Gaps
There are no published clinical trials, case reports, or observational studies examining serratiopeptidase use during pregnancy. The existing research literature on serratiopeptidase focuses exclusively on:
- Anti-inflammatory and analgesic effects in non-pregnant populations 2, 3
- Breast engorgement treatment postpartum (not during pregnancy) 4
- Topical formulation development 5
A systematic review of serratiopeptidase concluded that "the existing scientific evidence for Serratiopeptidase is insufficient to support its use" and noted that "data on long-term safety of this enzyme is lacking." 2 This review found that clinical studies were of poor methodology with small sample sizes, unspecified dosing, and no safety data. 2
Risk Assessment Framework
When evaluating any medication during pregnancy, the following hierarchy applies:
- Proven teratogens (Category X/D): Absolutely contraindicated 6
- Insufficient evidence medications: Avoid unless maternal benefit clearly outweighs unknown fetal risk 6
- Well-studied safe medications: Preferred options 6
Serratiopeptidase falls into the "insufficient evidence" category with no human pregnancy data whatsoever. 1, 2
Clinical Decision Algorithm
For conditions where serratiopeptidase might be considered (inflammation, pain, edema):
- Identify the specific indication requiring treatment
- Select evidence-based alternatives with established pregnancy safety profiles 6
- Reserve unproven medications only for situations where no safer alternative exists and maternal benefit is substantial 6
Common Pitfall to Avoid
Do not assume that "natural" or enzyme-based products are inherently safe during pregnancy. The proteolytic nature of serratiopeptidase means it could theoretically affect placental function or fetal development, though this has never been studied. 2, 3 The absence of reported harm is not evidence of safety—it reflects the absence of any pregnancy studies. 2
Breastfeeding Considerations
The FDA label extends the same caution to breastfeeding: "If pregnant or breastfeeding, ask a healthcare professional before use." 1 No data exist on serratiopeptidase excretion into breast milk or effects on nursing infants. 1