Animal studies have revealed evidence of fetotoxicity; no evidence of teratogenicity in rats (oral and IV doses) or cynomolgus macaques (oral doses). In rats, reduced fetal weights and slightly delayed fetal skeletal development were seen with oral doses (up to 500 mg/kg/day or 0.24 times the maximum recommended human dose [MRHD] based on AUC), while maternal toxicity and minor effects on fetal and placental weights and placental appearance were observed with IV doses of 80 mg/kg/day (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 at oral doses of 500 mg/kg/day. In rabbits, reduced fetal weights, delayed fetal skeletal ossification, increased fetal and litter incidence of rib and vertebral malformations, increased fetal incidence 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 of 20 mg/kg/day (about equal to oral MRHD based on AUC). In cynomolgus macaques, increased incidence of smaller fetal size was observed with oral doses of 100 mg/kg/day (2.5 times MRHD based on AUC). Animal studies suggest placental drug transfer occurs. 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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Use is not recommended.
-According to some authorities: Use is contraindicated.
-According to some authorities: 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: Not assigned.

Risk summary: Based on animal data, this drug may cause fetal harm; no human data available on use of this drug to inform a drug-related risk.

Comments:
-If this drug is used during pregnancy, the patient should be apprised of the potential harm to the fetus.

See references

According to preclinical evidence, small amounts of this drug may be secreted in 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; 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: Use is considered acceptable with monitoring of the infant for possible effects on the gastrointestinal flora (e.g., diarrhea or candidiasis [thrush, diaper rash]); however, use of an alternate drug with safety data available is preferred.
-According to some authorities: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
-According to some authorities: Use is contraindicated.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-No data available regarding use of this drug during breastfeeding.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered

See references