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Norfloxacin Pregnancy and Breastfeeding Warnings

Norfloxacin is also known as: Noroxin

Norfloxacin Pregnancy Warnings

Norfloxacin has been assigned to pregnancy category C by the FDA. High-dose animal studies have revealed evidence of embryolethality. There are no controlled data in human pregnancy. Surveillance studies have not reported an increased risk of major birth defects. However, cartilage damage and arthropathies have been reported in immature animals giving rise to concern over effects on fetal bone formation. Because safer alternatives are generally available, some experts consider norfloxacin contraindicated during pregnancy, especially during the first trimester. The manufacturer only recommends use of norfloxacin during pregnancy when benefit outweighs risk.

Of 549 cases reported by the European Network of Teratology Information Services involving fluoroquinolone exposure (including norfloxacin), congenital malformations were reported in 4.8%; however, this was not higher than the background rate. In the Michigan Medicaid study, major birth defects were reported in 5 of 139 exposed neonates. Berkovitch et al. reviewed 35 pregnancies in women who received norfloxacin or ciprofloxacin during the first trimester for the treatment of urinary tract infections. No malformations were reported among these infants. When compared to infants not exposed to quinolones, there was no difference in the acquisition of developmental milestones and no joint problems or walking delays.

Norfloxacin Breastfeeding Warnings

It is not known whether norfloxacin is excreted into human milk. However, since other fluoroquinolone antibiotics are excreted into human milk, it is likely that norfloxacin is also. 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. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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