[Effect of fosfomycin-calcium on reproductive performance of rats. II. Fertility test (author's transl)].
Fosfomycin calcium (FOM-Ca) was orally administered to Wistar rats for 60 consecutive days in males and 14 consecutive days in females in varying doses of 140 mg/kg, 700 mg/kg and 1,400 mg/kg, and then the animals were subjected to mating. It was further administered to pregnant female rats for another week to investigate its effects upon the embryos and fetus. The following results were obtained. 1) In parent animals, soft stools were noted in both sexes of the groups with higher doses, but otherwise there was no remarkable abnormality noted. 2) No increase was seen in the rates of development of dead embryos or externally abnormal fetus. 3) Skeletal abnormality was seen only slightly in the animals of the group with 700 mg/kg, but otherwise all the other groups were similar to the control group, showing that there would be no adverse effects by the tested drug upon the fetal skeletal structure. 4) On the ground of the above-mentioned test results, it was claimed that FOM-Ca exerts adverse effects upon the fetus of rats even in the dose of 700 mg/kg and that the safe dose to fetus of rats would be 140 mg/kg. It was also judged that it has no teratogenicity through administration before or at the initial stage of gestation.