GATIFLOXACIN

Fetal Risk Summary

Gatifloxacin is a synthetic, broad-spectrum, fluoroquinolone antibacterial agent. It is in the same antiinfective class as ciprofloxacin, enoxacin, lomefloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin, sparfloxacin, and trovafloxacin. Gatifloxacin is available in both oral and injectable formulations (1).

In reproduction studies with rats and rabbits, oral doses up to 0.7 and 1.9 times the maximum human dose based on exposure determined by the area under the plasma concentration curve (MHD), respectively, were not teratogenic (1). Rat fetal toxicity (delayed skeletal ossification, including wavy ribs) was noted at doses (0.7 times the MHD, and skeletal malformations occurred at about 1.0 times the MHD. Additional evidence of rat fetal toxicity, at doses 1.0 times the MHD given late in pregnancy and continuing during lactation, included increases in postimplantation loss and neonatal and perinatal death. No adverse fetal effects were seen at doses of 0.2 and 1.9 times the MHD, respectively, in rats or rabbits. No adverse effects on fertility or reproduction were observed in rats at oral doses up to about 1.0 times the MHD (1).

It is not known if gatifloxacin crosses the human placenta. The molecular weight of the hydrate (about 402) is low enough that transfer to the fetus should be expected.

No reports describing the use of either the IV or oral forms of gatifloxacin during human pregnancy have been located. The animal toxicity observed at doses equivalent to the maximum human exposure should be considered before this antiinfective is used in pregnant women. Moreover, some reviewers have concluded that all fluoroquinolones should be considered contraindicated in pregnancy (e.g., Ciprofloxacin and Norfloxacin), because safer alternatives are usually available.

Breast Feeding Summary

No reports describing the use of gatifloxacin in human lactation have been located. The molecular weight (about 402 for the hydrated form) suggests that the agent will be excreted into breast milk. Gatifloxacin is excreted in the milk of lactating rats (1). The effects of this exposure on a nursing infant are unknown. Because of the potential for serious adverse effects, women taking gatifloxacin should probably not breast feed.

Reference