The objective of the study was to check the effect of
oxoline acid, a bactericidal
drug for the treatment of
urinary tract infection during pregnancy, on
congenital abnormalities of informative offspring and fetal development. Human data of
oxoline acid use during pregnancy have not been reported, but the use of this
quinolone derivative is not recommended during pregnancy by the US Food and Drug Administration. The teratogenic and fetotoxic potential of
oxoline acid was evaluated in the population-based large data set of the Hungarian Case-Control Surveillance of
Congenital Abnormalities between 1980 and 1996. Observed and expected numbers of
congenital abnormalities were compared in the newborn infants and fetus of case mothers with
oxoline acid treatment. In addition, gestational age and
birthweight were evaluated in control newborn infants born to mothers with or without
oxoline acid treatment. Of 38,151 newborn infants without any
congenital abnormalities (control group), 13 (0.03%) had mothers who were treated with
oxoline acid, while of 22,843 cases with
congenital abnormalities, five (0.02%) had mothers who were treated with
oxoline acid during pregnancy (POR with 95% CI: 0.6, 0.2-1.8). The comparison of observed and expected number of different
congenital abnormalities did not show the teratogenic potential of
oxoline acid. There was a 0.9 weak shorter gestational age without a smaller
birthweight in the newborn infants born to mothers with
oxoline acid treatment. Our data did not indicate teratogenic and fetotoxic effect of
oxoline acid, however, the number of cases and controls was limited.