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Ofloxacin Pregnancy and Breastfeeding Warnings

Ofloxacin is also known as: Floxin, Floxin IV

Ofloxacin Pregnancy Warnings

Ofloxacin has been assigned to pregnancy category C by the FDA. Animal studies using high doses have revealed evidence of fetotoxicity and teratogenicity. There are no controlled data in human pregnancy. Surveillance studies have not reported an increased risk of major birth defects. However, cartilage damage and arthropathy are reported in immature animals giving rise to concern over effects on bone formation in the developing fetus. Because safer alternatives are available, some experts consider ofloxacin contraindicated during pregnancy, especially during the first trimester. The manufacturer only recommends use of ofloxacin during pregnancy when benefit outweighs risk.

Of 549 cases reported by the European Network of Teratology Information Services involving fluoroquinolone exposure (including ofloxacin), congenital malformations were reported in 4.8%; however, this was not higher than the background rate.

Ofloxacin Breastfeeding Warnings

Ofloxacin is excreted into human milk. Breast milk concentrations approximate maternal serum concentrations. 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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