Nitrofurantoin and congenital abnormalities

Objective: To study human teratogenic potential of oral nitrofurantoin trea tment during pregnancy. Materials an Methods: Pair analysis of cases with c ongenital abnormalities and matched population controls in the population-b ased dataset of the Hungarian Case-Control Surveillance of Congenital Abnor malities, 1980-1996. Results: Of 38,151 pregnant women who had newborn infa nts without any congenital abnormalities (population control group), 774 (3 .4%); of 22,865; case pregnant women who had newborns or fetuses with conge nital abnormalities, 1079 (2.8%) and of 812 pregnant women who had newborns or fetuses with Down's syndrome (patient controls), 23 (2.8%) pregnant wom en were treated with nitrofurantoin. The above differences between populati on controls and cases may be connected with recall bias, because the case-c ontrol pair analysis did not indicate a teratogenic potential of nitrofuran toin use during the second and the third months of gestation, i.e. in the c ritical period for major congenital abnormalities. Conclusion: Treatment wi th nitrofurantoin during pregnancy does not present detectable teratogenic risk to the fetus. (C) 2001 Elsevier Science Ireland Ltd. All rights reserv ed.