Use of cephalosporins during pregnancy and in the presence of congenital abnormalities: A population-based, case-control study

OBJECTIVE: Our purpose was to study the human teratogenic potential of ceph alosporin treatment during pregnancy. STUDY DESIGN: Pair analysis of cases with congenital abnormalities and matc hed controls without congenital abnormalities was performed. The population -based data set of the Hungarian Case-Control Surveillance of Congenital Ab normalities, 1980-1996, was used. The participants included 22,865 pregnant women who had fetuses or newborn infants with congenital abnormalities, 38 ,151 pregnant women who had infants without any defects (population control group), and 812 mothers who were delivered of babies affected with Down sy ndrome (patient controls). RESULTS: In the case group, 308 (1.35%) pregnant women were treated with ce phalosporin. In the population and patient control groups, 440 (1.15%) and 16 (1.97%) pregnant women had similar treatments. The somewhat higher use o f cephalosporins, mainly oral cephalexin, in the case and patient control g roups was explained by recall bias. The comparison of the occurrence of med ically documented cephalosporin treatments during the second to third month s of gestation tie, the critical period for major congenital abnormalities) in different congenital abnormality groups with the referent data of the t otal population control group and the patient control group did not indicat e a detectable human teratogenic potential of the studied drug. CONCLUSION: Treatment with the studied cephalosporins during pregnancy does not seem to present a detectable teratogenic risk to the fetus. However, f urther studies are needed to clarify the teratogenic and fetal toxic effect s of different cephalosporins separately.