Is colchicine (nonsteroidal anti-inflammatory drug) safe to use during pregnancy?

Colchicine Safety in Pregnancy

Colchicine should be continued throughout pregnancy and does not require discontinuation during conception, pregnancy, or lactation, as current evidence demonstrates no increased risk of major fetal malformations or adverse pregnancy outcomes. 1

Key Recommendation

The most recent 2025 EULAR/PRES guidelines explicitly state that colchicine should NOT be discontinued during conception, pregnancy, or lactation, and that current evidence does not justify amniocentesis. 1 This represents a critical update from older manufacturer warnings that incorrectly listed pregnancy as a contraindication. 1

Evidence Supporting Safety

Pregnancy Outcomes

• No increased risk of major congenital malformations has been demonstrated with colchicine use during pregnancy. 1, 2
• No increased risk of miscarriage when colchicine is continued; in fact, one meta-analysis found significantly lower miscarriage rates in women taking colchicine compared to those who discontinued it. 2
• The 2025 systematic review and meta-analysis specifically informing EULAR recommendations found "no major complications in the reproductive system and offspring" with colchicine exposure. 1

Disease Control Considerations

• Untreated FMF during pregnancy carries significant risks: increased odds of preterm delivery (OR 1.67), with trends toward fetal growth restriction and hypertensive disorders. 1
• Maintaining inflammation control during pregnancy with safe drugs is the appropriate clinical decision, as disease activity poses greater risk than medication exposure. 1

Dosing and Monitoring

Standard Dosing

• Maximum recommended doses remain 3 mg daily in adults and 2 mg daily in children for FMF treatment. 1
• No dose adjustment is required during pregnancy for standard therapeutic doses. 1

Male Fertility

• Men do not need to stop colchicine at recommended doses when planning conception, based on current data and expert consensus. 1
• Colchicine is listed as compatible for use in men attempting conception. 1

Lactation Safety

Colchicine is compatible with breastfeeding. 1

• Only one controlled study with low risk of bias examined 37 colchicine-exposed breastfed infants and found no abnormal growth. 1
• Exclusively breastfed infants receive less than 10% of the maternal weight-adjusted dose. 3
• Practical recommendation: Take colchicine immediately after breastfeeding to minimize infant exposure. 1

Critical Drug Interactions During Pregnancy

Colchicine has a narrow therapeutic index and potentially fatal interactions with CYP3A4 and P-glycoprotein inhibitors. 1

High-Risk Combinations to Avoid:

• Macrolide antibiotics (clarithromycin, erythromycin) - can increase colchicine levels 200-300%. 1, 4
• Azole antifungals (ketoconazole). 1, 4
• Immunosuppressants (cyclosporine) - particularly important in transplant patients. 1
• Statins - increased myopathy risk. 4
• Protease inhibitors (ritonavir). 1

Common Pitfalls to Avoid

Misconception About Contraindication

• The most significant barrier to appropriate care is the outdated belief that colchicine is contraindicated in pregnancy. 1
• Some manufacturer brochures incorrectly list pregnancy as a contraindication, contradicting current evidence-based guidelines. 1
• Healthcare providers must educate obstetricians that colchicine is safe during pregnancy. 1

Amniocentesis Not Indicated

• Routine amniocentesis is NOT recommended for women taking colchicine during pregnancy. 1
• Older literature suggesting chromosomal anomaly screening is not supported by current evidence. 5

Pregnancy Planning

• Pregnancy should ideally be planned during disease quiescence, but colchicine should be continued throughout. 1
• Do not attempt to taper or discontinue colchicine when pregnancy is achieved. 1

FDA Classification Context

The FDA labels colchicine as Pregnancy Category C, stating "should be used during pregnancy only if the potential benefit justifies the potential risk." 3 However, this conservative classification does not reflect the substantial body of evidence from FMF populations demonstrating safety, which forms the basis for the more definitive EULAR recommendations. 1

Toxicity Prevention During Pregnancy

Risk Factors for Toxicity:

• Exceeding recommended doses (>3 mg/day in adults). 1
• Renal or hepatic impairment - colchicine elimination half-life can increase up to sevenfold in liver cirrhosis. 1
• Concomitant interacting medications as listed above. 1

Patient Education Essential:

• Educate patients about colchicine's narrow therapeutic index to prevent accidental overdose. 1
• Ensure awareness of drug interactions, particularly with antibiotics commonly prescribed during pregnancy. 1