Is colchicine safe for use during pregnancy?

Colchicine Safety During Pregnancy

Colchicine is safe for use throughout pregnancy and is strongly recommended as compatible with pregnancy by current rheumatology guidelines. 1

Evidence-Based Recommendation

The 2020 American College of Rheumatology (ACR) guidelines for reproductive health in rheumatic diseases provide the most definitive guidance on this topic, explicitly stating that colchicine is strongly recommended as compatible for use throughout pregnancy 1. This recommendation is based on substantial clinical experience and safety data.

Safety Profile During Pregnancy

• Colchicine crosses the placenta but has not been associated with increased risk of:

  • Fetal malformations
  • Miscarriage (in fact, studies show lower miscarriage rates in women taking colchicine) 2
  • Adverse pregnancy outcomes

• The FDA classifies colchicine as Pregnancy Category C, indicating that it should be used "only if the potential benefit justifies the potential risk to the fetus" 3

• A 2018 systematic review and meta-analysis found that colchicine use throughout pregnancy:

  • Was not associated with increased incidence of miscarriage
  • Was not associated with increased major fetal malformations
  • Actually showed significantly lower incidence of miscarriage in women taking colchicine 2

Specific Recommendations for Different Conditions

For Familial Mediterranean Fever (FMF)

• Colchicine should not be discontinued during conception, pregnancy, or lactation 1
• Continuing colchicine prevents febrile attacks and reduces renal complications 4
• No evidence of impact on birthweight or gestational age in FMF patients 2

For Pericardial Diseases

• European Society of Cardiology (ESC) guidelines note that colchicine is considered contraindicated during pregnancy and breastfeeding in some manufacturer brochures
• However, they acknowledge that no adverse events during pregnancy and fetal development have been reported in women with FMF treated with colchicine during pregnancy 1

Important Considerations

Dosing and Monitoring

• Standard therapeutic doses should be maintained (typically 1.2-2.4 mg/day for FMF)
• Avoid doses exceeding 0.5 mg/kg, as high doses can be toxic 5
• Monitor renal function, as colchicine clearance is decreased in patients with impaired renal function 3

Drug Interactions

• Avoid co-administration with CYP3A4 and P-glycoprotein inhibitors such as:
  • Macrolide antibiotics (clarithromycin, erythromycin)
  • Ketoconazole
  • Cyclosporine
  • Grapefruit juice 5

Breastfeeding Considerations

• Colchicine is excreted into breast milk
• Breastfed infants receive less than 10% of the maternal weight-adjusted dose
• No published reports of adverse effects in breastfeeding infants
• Considered compatible with breastfeeding, though caution is advised 3

Common Pitfalls to Avoid

1. Discontinuing colchicine unnecessarily: Stopping colchicine during pregnancy may lead to disease flares and complications that pose greater risks than continuing the medication.

2. Failing to monitor for drug interactions: Certain medications can increase colchicine concentrations and toxicity risk.

3. Confusing manufacturer warnings with clinical evidence: Despite some manufacturer warnings, clinical evidence supports colchicine's safety in pregnancy.

4. Not adjusting dosing in renal impairment: Patients with renal dysfunction require careful monitoring and potential dose adjustment.

In conclusion, colchicine can be safely continued throughout pregnancy when clinically indicated, with the benefits of disease control generally outweighing potential risks. This recommendation is strongly supported by current rheumatology guidelines and clinical evidence.