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Colchicine / probenecid Pregnancy and Breastfeeding Warnings

Colchicine / probenecid is also known as: Proben-C, Probenecid and Colchicine

Colchicine / probenecid Pregnancy Warnings

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. Case reports of probenecid use throughout pregnancy for the treatment of hyperuricemia associated with gout and renal dysfunction have not documented probenecid-induced adverse fetal outcome. In addition, one study evaluating the efficacy of single-dose ampicillin plus probenecid for the treatment of urinary tract infection during pregnancy failed to reveal evidence of adverse fetal effects. However, further data are required to fully evaluate the safety of probenecid therapy during pregnancy.

Colchicine-probenecid has not been formally assigned to a pregnancy category by the FDA. Colchicine has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity. Colchicine has been reported to adversely affect spermatogenesis in animals. Reversible azoospermia has been reported. There are no controlled data in human pregnancy. Colchicine crosses the human placenta. Colchicine is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk. Probenecid has been assigned to a pregnancy category B by the FDA. There are no controlled data in human pregnancy. Probenecid is known to cross the placental barrier. Probenecid is only recommended for use during pregnancy when benefit outweighs risk. According to the manufacturer, because of the colchicine component, colchicine-probenecid is considered contraindicated during pregnancy.

Colchicine / probenecid Breastfeeding Warnings

There are no data on the excretion of colchicine-probenecid into human milk. Colchicine is excreted into human milk in small amounts. The manufacturers state that colchicine is considered compatible with breast-feeding by the American Academy of Pediatrics. There are no data on the excretion of probenecid into human milk.

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. Another study showed that the amount of colchicine an infant would receive during the 8 hours following a maternal dosing was about 10% of the mg/kg dose taken by the mother (assuming 100% bioavailability in the infant).

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