A population-based case-control study of oral griseofulvin treatment during pregnancy.

AIM: To study the teratogenicity of oral griseofulvin during pregnancy.

METHODS: The data of the population-based Hungarian Case-Control Surveillance of Congenital Abnormalities between 1980 and 1996 and the Hungarian Congenital Abnormality Registry between 1970 and 2002 were evaluated.

RESULTS: In total, 38,151 pregnant women who delivered newborn infants without any defects (control group) and 22,843 pregnant women who had fetuses or newborns with congenital abnormalities were included in the study. Seven (0.03%) case and 24 (0.06%) control pregnant women were treated with the griseofulvin (crude odds ratio with 95% confidence interval: 0.49, 0.21-1.13). A teratogenic potential of griseofulvin was not indicated by a comparison of the expected and observed number of different congenital abnormalities. A higher mean birth weight was found in control newborn infants born to mothers with griseofulvin treatment compared with the data of control newborn infants without this treatment. In addition, 55 conjoined twins were evaluated in the data set of the Hungarian Congenital Abnormality Registry, and no conjoined twins had mother with griseofulvin treatment during pregnancy.

CONCLUSION: Our data do not indicate a detectable teratogenic risk of oral griseofulvin treatment during pregnancy; however, the numbers of cases and controls were limited. Therefore, international collaboration is needed for the final conclusion.