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Ciprofloxacin Pregnancy and Breastfeeding Warnings

Ciprofloxacin is also known as: Cipro, Cipro Cystitis Pack, Cipro I.V., Cipro XR, Proquin XR

Ciprofloxacin Pregnancy Warnings

Animal studies failed to reveal embryotoxicity or teratogenicity, although maternal toxicity in some animal studies resulted in increased incidence of abortion. There are no controlled data in human pregnancy. However, ciprofloxacin has been shown to distribute into amniotic fluid. Concentrations reported were 57% (at 2 to 4 hours post dose) to 1000% (at 10 to 12 hours post dose) of that found in maternal serum. A review by the Teratogen Information System concluded that a substantial risk is unlikely; however, there were insufficient data to state that there is no risk. Cartilage damage and arthropathies associated with ciprofloxacin have been reported in immature animals of various species, giving rise to concern over its possible toxic effects on human fetal bone formation. Because safer alternatives are generally available, some experts consider ciprofloxacin contraindicated during pregnancy, especially during the first trimester. Of 549 cases reported by the European Network of Teratology Information Services involving fluoroquinolone exposure (including ciprofloxacin), congenital malformations were reported in 4.8%; however, this was not higher than the background rate. In the U.S. Michigan Medicaid surveillance study of 229,101 pregnancies, major birth defects were reported in 3 of 132 exposed neonates. An association between ciprofloxacin and congenital defects is not supported by these data. Berkovitch and colleagues reviewed 35 pregnancies in women who received norfloxacin or ciprofloxacin during the first trimester for urinary tract infection. No malformations were observed among the infants of these women. There were no joint problems or walking delays, and when compared to nonexposed infants, there was no apparent difference in the acquisition of milestones. In mass casualty settings after release of biological weapons, the Working Group on Civilian Biodefense has recommended ciprofloxacin as the drug of choice for postexposure prophylaxis and treatment of anthrax, and as an alternative for tularemia and plague. The risk is outweighed by the high fatality rates from these infections. 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.

FDA pregnancy category: C Ciprofloxacin should not be used during pregnancy unless the potential benefit justifies the potential risk to both fetus and mother.

Ciprofloxacin Breastfeeding Warnings

Ciprofloxacin is excreted into human milk. Concentrations found in breast milk have ranged from 85% (at 24 hours post dose) to 214% (at 4 hours post dose) of maternal serum concentration. In one case report, a 2-month-old girl developed perforated pseudomembranous colitis following ingestion of ciprofloxacin via the mother's milk and subsequently required a bowel resection. In addition, quinolone-induced cartilage erosion and arthropathies that have been observed in juvenile animals render some concern over its possible toxic effects on the developing joints of nursing infants. Ciprofloxacin is considered compatible with breast-feeding by the American Academy of Pediatrics. Because of the potential for serious adverse effects in nursing infants, a decision should be made to discontinue nursing or discontinue administration of ciprofloxacin, taking into account the importance of the drug to the mother.

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