Can I take colchicine while pregnant or breastfeeding?

8.1 Pregnancy Risk Summary Available data from published literature on colchicine use in pregnancy over several decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Colchicine crosses the human placenta. Although animal reproductive and developmental studies were not conducted with colchicine, published animal reproduction and development studies indicate that colchicine causes embryofetal toxicity, teratogenicity and altered postnatal development at exposures within or above the clinical therapeutic range. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Prescribing label, section “8.1 Pregnancy” (opening excerpt): colchicine (oral), A-S Medication Solutions. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

Long-term prophylactic maternal doses of colchicine up to 1.5 mg daily produce levels in milk that result in the infant receiving less than 10% of the maternal weight-adjusted dosage. The highest milk levels occur 2 to 4 hours after a dose, so avoiding breastfeeding during this time can minimize the infant dose, although some clinicians simply recommend taking the drug after nursing. No adverse effects in breastfed infants have been reported in case series and a case-control study and many experts and professional guidelines consider colchicine safe during breastfeeding in women being treated for familial Mediterranean fever or rheumatic conditions.[1-5]

“Summary of Use during Lactation”, LactMed record “Colchicine” (LM348), quoted verbatim. Everything LactMed reports about Colchicine while breastfeeding.

8.2 Lactation Risk Summary Colchicine is present in human milk (see Data) . Adverse events in breastfed infants have not been reported in the published literature after administration of colchicine to lactating women. There are no data on the effects of colchicine on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for colchicine and any potential adverse effects on the breastfed child from colchicine or from the underlying maternal condition. Data Limited published data from case reports and a small lactation study demonstrate that colchicine is present in breastmilk. A systematic review of literature reported no adverse effects in 149 breastfed children. In a prospective observational cohort study, no gastrointestinal or other symptoms were reported in 38 colchicine-exposed breastfed infants.

Prescribing label, section “8.2 Lactation”: colchicine (oral), A-S Medication Solutions. Label on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.