Autoinflammatory & rare systemic diseases
Safety of colchicine on fertility, pregnancy, and lactation: a systematic review and meta-analysis informing the EULAR/PReS recommendations for familial Mediterranean fever
Pooled result · Miscarriage or foetal lossResult — go to the resultRelative risk 0.87 95% CI 0.67–1.12Authors' conclusion
Colchicine appears to have a good risk-benefit profile regarding reproductive safety.
Study context
- Population
- Patients with familial Mediterranean fever (FMF); clinical trials, cohort studies or case series on colchicine safety concerning reproductive issues or breastfeeding, with at least 5 patients25 studies
- Comparison
- Colchicine exposure vs no colchicine exposure in FMF
- Outcome
- Miscarriage or foetal loss
Methodological detailsfixed-effect models, Mantel-Haenszel method, risk of bias assessed with the Newcastle-Ottawa Scale, Studies of moderate to low quality
- Fixed-effect models
- Mantel-Haenszel method
- Risk of bias assessed with the Newcastle-Ottawa Scale
- Studies of moderate to low quality
Pooled result
As reported in the abstract
Relative risk
0.87
95% CI 0.67–1.12
Colchicine-exposedvs Nonexposed
RR 0.87 (95% CI 0.67–1.12)
Further pooled results
- Birth defects — Colchicine-exposed
- range 0.6% to 4.0%
Birth defects
- Not very different, comparable to rates of women with FMF without colchicine exposure
Fertility (women and men, sperm assessment)
- No apparent differences between colchicine-exposed and nonexposed groups, neither among women nor men
Breastfeeding: growth of babies
- No growth differences among exposed and nonexposed babies
- Only 1 study reported breastfeeding data
Original publication
Safety of colchicine on fertility, pregnancy, and lactation: a systematic review and meta-analysis informing the EULAR/PReS recommendations for familial Mediterranean fever. Ann Rheum Dis. Published 28 February 2025. doi:10.
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