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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

Teratogenicity has been shown in mice given 1.25 to 1.5 mg/kg and hamsters given colchicine 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. 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. Probenecid crosses the placenta barrier and appears in cord blood. 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. There are no adequate and well controlled studies in pregnant women taking either agent individually or the combination of both drugs together. 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. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Contraindicated US FDA pregnancy category: Not formally assigned -Colchicine: C -Probenecid: B

See references

Colchicine / probenecid Breastfeeding Warnings

Safety has not been established Excreted into human milk: Yes (colchicine); Yes (probenecid) Comments: The effects in the nursing infant are unknown.

Colchicine: Highest milk levels occur 2 to 4 hours post-dose. Limited data suggests that exclusively breastfed infants would receive less than 10% of the maternal weight-adjusted dose. Probenecid: Limited data has shown that maternal doses up to 2 g/day have resulted in low excreted into human milk. There are no studies describing combination use in breastfeeding.

See references

References for pregnancy 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. "Product Information. Colcrys (colchicine)." AR Scientific Inc, Philadelphia, PA.
  3. Batt RE, Cirksena WJ, Lebherz TB "Gout and salt-wasting renal disease during pregnancy." JAMA 186 (1963): 835-8
  4. 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
  5. Merlin HE "Azoospermia caused by colchicine--a case report." Fertil Steril 23 (1972): 180-1
  6. Bremner WJ, Paulsen CA "Colchicine and testicular function in man." N Engl J Med 294 (1976): 1384-5
  7. "Product Information. Benemid (probenecid)." Merck & Co, Inc, West Point, PA.
  8. Adelson MD, Graves WL, Osborne NG "Treatment of urinary infections in pregnancy using single versus 10-day dosing." J Natl Med Assoc 84 (1992): 73-5
  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. Kelsall JT, Ohanlon DP "Gout during pregnancy." J Rheumatol 21 (1994): 1365-6
  11. Ben-Chetrit E, Levy M "Colchicine prophylaxis in familial Mediterranean fever: reappraisal after 15 years." Semin Arthritis Rheum 20 (1991): 241-6
  12. 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
  13. 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
  14. Ben-Chetrit E, Levy M, Eliakim M "Therapeutic rounds. Colchicine therapy for familial Mediterranean fever." Clin Ther 8 (1986): 481,586-7
  15. "Product Information. Colchicine-Probenecid (colchicine-probenecid)." Watson Pharmaceuticals, Corona, CA.
  16. 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
  17. Lee FI, Loeffler FE "Gout and pregnancy." J Obstet Gynaecol Br Commonw 69 (1962): 299-304

References for breastfeeding information

  1. "Product Information. Colchicine-Probenecid (colchicine-probenecid)." Watson Pharmaceuticals, Corona, CA.

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