Nitrofurantoin and congenital abnormalities.
OBJECTIVE
To study human teratogenic potential of oral nitrofurantoin treatment during pregnancy.


METHODS
Pair analysis of cases with congenital abnormalities and matched population controls in the population-based dataset of the Hungarian Case-Control Surveillance of Congenital Abnormalities, 1980-1996.


RESULTS
Of 38,151 pregnant women who had newborn infants without any congenital abnormalities (population control group), 774 (3.4%); of 22,865 case pregnant women who had newborns or fetuses with congenital abnormalities, 1079 (2.8%) and of 812 pregnant women who had newborns or fetuses with Down's syndrome (patient controls), 23 (2.8%) pregnant women were treated with nitrofurantoin. The above differences between population controls and cases may be connected with recall bias, because the case-control pair analysis did not indicate a teratogenic potential of nitrofurantoin use during the second and the third months of gestation, i.e. in the critical period for major congenital abnormalities.


CONCLUSIONS
Treatment with nitrofurantoin during pregnancy does not present detectable teratogenic risk to the fetus.
Czeizel
A E
AE
Department of Human Genetics and Teratology, Foundation for the Community Control of Hereditary Diseases, National Centre for Epidemiology, Torokvesz Lejto 32, 1026, Budapest, Hungary. czeizel@interware.hu
Rockenbauer
M
M
Sørensen
H T
HT
Olsen
J
J
D000014:Abnormalities, Drug-Induced / Q000453:epidemiology*; D000328:Adult; D000892:Anti-Infective Agents, Urinary / Q000009:adverse effects*; D016022:Case-Control Studies; D005260:Female; D006801:Humans; D006814:Hungary / Q000453:epidemiology; D008423:Maternal Age; D009582:Nitrofurantoin / Q000009:adverse effects*; D011247:Pregnancy; D011248:Pregnancy Complications / Q000453:epidemiology; D015203:Reproducibility of Results
D000892:Anti-Infective Agents, Urinary; D009582:Nitrofurantoin