Sparfloxacin Pregnancy and Breastfeeding Warnings

Brand names: Zagam, Zagam Respipac

Sparfloxacin Pregnancy Warnings

Sparfloxacin has been assigned to pregnancy category C by the FDA. High-dose animal studies revealed no evidence of teratogenicity. However, when studied in rats at maternally toxic doses (9.3 times the maximum human dose based on mg/m2) there was an increased incidence of fetuses with ventricular septal defects. This event was not observed in monkeys or rabbits at maternally toxic doses. 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 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 sparfloxacin contraindicated during pregnancy, especially during the first trimester. The manufacturer only recommends use of sparfloxacin during pregnancy when benefit outweighs risk.

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.

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Sparfloxacin Breastfeeding Warnings

Sparfloxacin is excreted into human 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. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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Further information

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