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Rifampin Pregnancy and Breastfeeding Warnings

Rifampin is also known as: Rifadin, Rifadin IV, Rimactane

Rifampin Pregnancy Warnings

FDA pregnancy category: C Potential benefit should outweigh the potential risk.

Animal studies have revealed evidence of embryotoxicity and teratogenicity. Congenital malformations (mainly spina bifida) were increased in the offspring of rats given rifampin during organogenesis at oral doses about 1 to 2 times the maximum recommended human dose (based on body surface area comparisons). Cleft palate was increased in fetuses of mice given oral doses about 0.2 to 0.8 times the maximum recommended human dose (based on body surface area comparisons). Imperfect osteogenesis and embryotoxicity were reported in rabbits given oral doses up to about 3 times the maximum recommended human dose (based on body surface area comparisons). There are no controlled data in human pregnancy. Rifampin crosses the human placenta and appears in cord blood. Data reveal a fetal:maternal serum concentration ratio of 0.23. Reports of the use of rifampin during pregnancy generally involve multiple drug therapy. In a review of 204 pregnancies during which exposure to rifampin occurred, 7 malformations were thought to be due to drug therapy, including anencephaly (1 case), hydrocephalus (2 cases), limb malformations (3 cases), and renal tract abnormalities (1 case). Postnatal hemorrhages in the mother and infant have been associated with the use of rifampin during the last few weeks of pregnancy; administration of vitamin K may be indicated. The initial therapy of active tuberculosis in pregnant patients recommended by the Centers for Disease Control includes rifampin. Rifampin is also recommended by the American Thoracic Society. 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

Rifampin Breastfeeding Warnings

Rifampin is excreted into human milk. Due to the potential for serious adverse effects in nursing infants, the decision should be made to either discontinue nursing or discontinue the drug based on the importance of the therapy to the mother.

See references

References for pregnancy information

  1. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  2. Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
  3. Steen JSM, Stainton-Ellis DM "Rifampicin in pregnancy." Lancet 2 (1977): 604-5
  4. Rocker I "Rifampicin in early pregnancy." Lancet 2 (1977): 48
  5. Lessnau KD, Qarah S "Multidrug-resistant tuberculosis in pregnancy: case report and review of the literature." Chest 123 (2003): 953-6
  6. Bromberg YM, Salzberger M, Bruderman I "Placental transmission of isonicotinic acid hydrazide." Gynaecologia 140 (1955): 141-4
  7. "Product Information. Rifadin (rifampin)." Hoechst Marion-Roussel Inc, Kansas City, MO.
  8. Eggermont E, Logghe N, Van De CAsseye M, et al. "Haemorrhagic disease of the newborn in the offspring of rifampicin and isoniazid treated mothers." Acta Paediatr Belg 29 (1976): 87-90
  9. American Thoracic Society, Centers for Disease Control "Treatment of tuberculosis and tuberculosis infection in adults and children." Am Rev Respir Dis 134 (1986): 355-63
  10. CDC "Initial therapy for tuberculosis in the era of multidrug resistance. Recommendations of the advisory council for the elimintion of tuberculosis." MMWR Morb Mortal Wkly Rep 42 (1993): 1-8
  11. Lowe CR "Congenital defects among children born to women under supervision or treatment for pulmonary tuberculosis." Br J Prev Soc Med 18 (1964): 14-6
  12. Snider DE Jr, Layde PM, Johnson MW, Lyle MA "Treatment of tuberculosis during pregnancy." Am Rev Respir Dis 122 (1980): 65-79
  13. Holdiness MR "Transplacental pharmacokinetics of the antituberculosis drugs." Clin Pharmacokinet 13 (1987): 125-9
  14. Medchill MT, Gillum M "Diagnosis and management of tuberculosis during pregnancy." Obstet Gynecol Surv 44 (1989): 81-4

References for breastfeeding information

  1. "Product Information. Rifadin (rifampin)." Hoechst Marion-Roussel Inc, Kansas City, MO.
  2. Snider DE, Powell KE "Should women taking antituberculosis drugs breast-feed?" Arch Intern Med 144 (1984): 589-90
  3. Vorherr H "Drug excretion in breast milk." Postgrad Med 56 (1974): 97-104

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