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Colchicine Pregnancy and Breastfeeding Warnings

Colchicine is also known as: Colcrys, Mitigare

Colchicine Pregnancy Warnings

Colchicine has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity. There are no controlled data in human pregnancy. There are no adequate and well-controlled studies with colchicine in pregnant women. Colchicine crosses the human placenta. While not studied in the treatment of gout flares, data from a limited number of published studies found no evidence of an increased risk of miscarriage, stillbirth, or teratogenic effects among pregnant women using colchicine to treat familial Mediterranean fever (FMF). Colchicine should be used during pregnancy only when the potential benefits outweigh the potential risks.

One report found plasma levels of colchicine in a mother and an umbilical cord sample taken at delivery to be 3.15 and 0.47 ng/mL, respectively. The mother had received colchicine 1 mg orally once a day for the duration of the pregnancy. The baby weighed 3100 grams and had a normal Apgar score at birth. There have been a number of anecdotal reports of pregnant women who have taken colchicine without adverse fetal effects. A study of 231 pregnancies in 116 women treated with colchicine before or during pregnancy did not show an increased frequency of fetal defects. Another study of eleven pregnancies in women treated with colchicine throughout the pregnancy resulted in 9 healthy babies and 2 miscarriages. Occasional cases of trisomy or aneuploidy have been reported in patients being treated with colchicine for gout. A causal relationship is uncertain. Some early studies suggested an increase in Down's syndrome, but that association appears to be coincidental. In a study of 28 women with familial Mediterranean fever (FMF) who were taking colchicine, 25% had miscarriages and 36% had periods of infertility. These rates were high but similar to rates reported for women with FMF without colchicine. All 16 babies born to the FMF women on colchicine were healthy. Pregnant patients with FMF who are receiving colchicine, may need to be monitored to determine renal function during pregnancy. A summary of 3 studies showed 4 of 14 men taking colchicine developed reversible azoospermia. When tested in mice given 1.25 to 1.5 mg/kg and hamsters given 10 mg/kg, colchicine was shown to be teratogenic.

See references

Colchicine Breastfeeding Warnings

One report of a mother receiving colchicine 0.6 mg orally twice a day found that colchicine levels in breast milk were similar to levels in the plasma and much lower than levels in maternal urine. The nursing infant showed no adverse effects through the age of 6 months.

Colchicine is excreted into human milk. Limited information suggests that exclusively breastfed infants receive less than 10 percent of the maternal weight-adjusted dose. While there are no published reports of adverse effects in breast-feeding infants of mothers taking colchicine, colchicine can affect gastrointestinal cell renewal and permeability. The manufacturer warns that caution should be exercised when administering colchicine to breastfeeding women and their infants should be observed for adverse effects.

See references

References for pregnancy information

  1. Ben-Chetrit E, Levy M, Eliakim M "Therapeutic rounds. Colchicine therapy for familial Mediterranean fever." Clin Ther 8 (1986): 481,586-7
  2. Ben-Chetrit E, Levy M "Colchicine prophylaxis in familial Mediterranean fever: reappraisal after 15 years." Semin Arthritis Rheum 20 (1991): 241-6
  3. Kelsall JT, Ohanlon DP "Gout during pregnancy." J Rheumatol 21 (1994): 1365-6
  4. Guillonneau M, Aigrain EJ, Galliot M, Binet MH, Darbois Y "Colchicine is excreted at high concentrations in human breast milk." Eur J Obstet Gynecol Reprod Biol 61 (1995): 177-8
  5. Fukutani K, Ishida H, Shinohara M, Minowada S, Niijima T, Hijikata K, Izawa Y "Suppression of spermatogenesis in patients with Behcet's disease treated with cyclophosphamide and colchicine." Fertil Steril 36 (1981): 76-80
  6. Bremner WJ, Paulsen CA "Colchicine and testicular function in man." N Engl J Med 294 (1976): 1384-5
  7. Ehrenfeld M, Brzezinski A, Levy M, Eliakim M "Fertility and obstetric history in patients with familial Mediterranean fever on long-term colchicine therapy." Br J Obstet Gynaecol 94 (1987): 1186-91
  8. Merlin HE "Azoospermia caused by colchicine--a case report." Fertil Steril 23 (1972): 180-1
  9. Amoura Z, Schermann JM, Wechsler B, Zerah X, Goodeau P "Transplacental passage of colchicine in familial Mediterranean fever." J Rheumatol 21 (1994): 383
  10. Mordel N, Birkenfeld A, Rubinger D, Schenker JG, Sadovsky E "Successful full-term pregnancy in familial Mediterranean fever complicated with amyloidosis: case report and review of the literature." Fetal Diagn Ther 8 (1993): 129-34
  11. Rabinovitch O, Zemer D, Kukia E, Sohar E, Mashiach S "Colchicine treatment in conception and pregnancy: two hundred thirty- one pregnancies in patients with familial Mediterranean fever." Am J Reprod Immunol 28 (1992): 245-6

References for breastfeeding information

  1. Guillonneau M, Aigrain EJ, Galliot M, Binet MH, Darbois Y "Colchicine is excreted at high concentrations in human breast milk." Eur J Obstet Gynecol Reprod Biol 61 (1995): 177-8
  2. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  3. Milunsky JM "Breast-feeding during colchicine therapy for familial Mediterranean fever." J Pediatr 119 (1991): 164
  4. Mordel N, Birkenfeld A, Rubinger D, Schenker JG, Sadovsky E "Successful full-term pregnancy in familial Mediterranean fever complicated with amyloidosis: case report and review of the literature." Fetal Diagn Ther 8 (1993): 129-34
  5. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):

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