Colchicine Pregnancy and Breastfeeding Warnings
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.
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.
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