Rifampin Pregnancy and Breastfeeding Warnings
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.
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.
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