Of 549 cases reported by the European Network of Teratology Information Services involving exposure to other fluoroquinolones, congenital malformations were reported in 4.8%; however, this was not higher than the background rate.

Gatifloxacin has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of maternal toxicity, decreased fetal and placental weight, and delayed fetal skeletal ossification. There are no controlled data in human pregnancies. Because safer alternatives are generally available, some experts consider other fluoroquinolones contraindicated during pregnancy, especially during the first trimester. The manufacturer only recommends use of gatifloxacin during pregnancy when benefit outweighs risk.

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It is not known if gatifloxacin is excreted into human milk. However, since other fluoroquinolone antibiotics are excreted into human milk, it is likely that gatifloxacin 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 effects in nursing infants, a decision should be made to discontinue nursing or discontinue administration of gatifloxacin, taking into account the importance of the drug to the mother.

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