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Moxifloxacin Pregnancy and Breastfeeding Warnings

Moxifloxacin is also known as: Avelox, Avelox I.V.

Moxifloxacin Pregnancy Warnings

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.

Moxifloxacin has been assigned to pregnancy category C by the FDA. Studies with rats and rabbits have revealed evidence of maternal toxicity, decreased fetal and placental weight, rib and vertebral malformations, and delayed fetal skeletal ossification. Studies using doses of 100 mg/kg/day in cynomolgus monkeys did not reveal evidence of teratogenicity; however, there was an increased incidence of smaller fetal size. There are no controlled data in human pregnancy. Surveillance studies have not reported an increased risk of major birth defects with other quinolones. However, cartilage damage and arthropathies are reported in immature animals exposed to quinolones, giving rise to concern over effects on fetal bone formation. Because safer alternatives are available, some experts consider other quinolones contraindicated during pregnancy, especially during the first trimester. The manufacturer only recommends use of moxifloxacin during pregnancy when benefit outweighs risk.

Moxifloxacin Breastfeeding Warnings

There are no data on the excretion of moxifloxacin into human milk. However, since other fluoroquinolone antibiotics are excreted into human milk, it is likely that moxifloxacin is also excreted. It is excreted into rat milk. Cartilage erosion and arthropathy have been reported in immature animals giving rise to concern over toxic effects in 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 moxifloxacin, taking into account the importance of the drug to the mother.

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