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Colchicine Pregnancy and Breastfeeding Warnings

Colchicine is also known as: Colcrys, Mitigare

Colchicine Pregnancy Warnings

Use only if the potential benefit justifies the potential risk to the fetus. AU TGA pregnancy category: D US FDA pregnancy category: C Comments: -Use of adequate contraception should be discussed with women of child -bearing potential.

Teratogenicity has been shown in mice given 1.25 to 1.5 mg/kg and hamsters given 10 mg/kg, 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. Plasma levels of colchicine in a mother receiving 1 mg/day orally for the duration of her pregnancy were 3.15 ng/mL at delivery and an umbilical cord sample was 0.47 ng/mL. The baby weighed 3100 grams and had a normal Apgar score at birth. 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. There are no well-controlled studies in pregnant patients. A summary of 3 studies showed 4 of 14 men taking colchicine developed reversible azoospermia. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Colchicine Breastfeeding Warnings

Colchicine is excreted into human milk. The highest milk levels occur 2 to 4 hours postdose. Limited information suggests that exclusively breastfed infants receive less than 10% of the maternal weight-adjusted dose. While there are no published reports of adverse effects in breast-feeding infants, colchicine can affect gastrointestinal cell renewal and permeability. Caution should be exercised when administering colchicine to breastfeeding women and their infants should be observed for adverse effects.

Caution is recommended. Excreted into human milk: Yes Comments: -This drug has been used without apparent harmful effects in the nursing infant. -Avoiding breastfeeding during times of highest milk levels can minimize the infant dose.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Ben-Chetrit E, Levy M, Eliakim M "Therapeutic rounds. Colchicine therapy for familial Mediterranean fever." Clin Ther 8 (1986): 481,586-7
  3. "Product Information. Mitigare (colchicine)." Hikma Americas, Inc, Memphis, TN.
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  5. Ben-Chetrit E, Levy M "Colchicine prophylaxis in familial Mediterranean fever: reappraisal after 15 years." Semin Arthritis Rheum 20 (1991): 241-6
  6. Kelsall JT, Ohanlon DP "Gout during pregnancy." J Rheumatol 21 (1994): 1365-6
  7. 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
  8. 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
  9. 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
  10. 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
  11. "Product Information. Colcrys (colchicine)." AR Scientific Inc, Philadelphia, PA.
  12. Bremner WJ, Paulsen CA "Colchicine and testicular function in man." N Engl J Med 294 (1976): 1384-5
  13. Merlin HE "Azoospermia caused by colchicine--a case report." Fertil Steril 23 (1972): 180-1
  14. Amoura Z, Schermann JM, Wechsler B, Zerah X, Goodeau P "Transplacental passage of colchicine in familial Mediterranean fever." J Rheumatol 21 (1994): 383
  15. 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

References for breastfeeding information

  1. "Product Information. Colcrys (colchicine)." AR Scientific Inc, Philadelphia, PA.
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  3. "Product Information. Mitigare (colchicine)." Hikma Americas, Inc, Memphis, TN.
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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