Moxifloxacin Pregnancy and Breastfeeding Warnings
Moxifloxacin Pregnancy Warnings
Animal studies have revealed evidence of fetotoxicity; no evidence of teratogenicity in rats (oral and IV doses) or cynomolgus monkeys (oral doses). In rats, reduced fetal weights, slightly delayed fetal skeletal development, maternal toxicity, and minor effects on placental weight and appearance were observed with oral doses (0.24 times the maximum recommended human dose [MRHD] based on AUC) or IV doses (about 2 times MRHD based on body surface area). In a pre- and postnatal development study in rats, slight increases in pregnancy duration and prenatal loss, reduced pup birth weight and neonatal survival, and therapy-related maternal mortality during gestation were observed with oral doses. In rabbits, reduced fetal weights, increased incidence (fetal and litter) of rib and vertebral malformations, delayed fetal skeletal ossification, increased incidence (fetal) of prominent liver lobulation, and maternal toxicity (including mortality, abortions, markedly reduced food consumption, reduced water intake, weight loss, hypoactivity) were observed with IV doses (about equal to oral MRHD based on AUC). In cynomolgus monkeys, increased incidence of smaller fetal size was observed with oral doses (2.5 times MRHD based on AUC). Animal studies suggest placental drug transfer. 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. 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. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
AU: Use is not recommended. UK: Use is contraindicated. US: This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: C Comments: Based on animal data, this drug may cause fetal harm.
Moxifloxacin Breastfeeding Warnings
Cartilage erosion and arthropathy have been reported in immature animals giving rise to concern over toxic effects in the developing joints of nursing infants; however, some studies suggest risk is low. Absorption of the small amounts of fluoroquinolones in milk may be blocked by the calcium in milk; data insufficient to prove or disprove.
LactMed: Short-term use is considered acceptable; however, use of an alternate drug is preferred. -AU, US: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. -GB: Use is contraindicated. Excreted into human milk: Yes (small amounts) Comments: The effects in the nursing infant are unknown.
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