European Journal of Obstetrics & Gynecology and Reproductive Biology
Nitrofurantoin and congenital abnormalities
Introduction
Nitrofurantoin is an antimicrobial agent used for the treatment and prevention of urinary tract infections. About 4% of pregnant women with covert bacteriuria, acute cystitis and pyelonephritis were treated by nitrofurantoin in Hungary during the 1980s. Therapeutic doses of nitrofurantoin are unlikely to pose a substantial teratogenic risk, but the available data are insufficient to state that there is no risk [1], [2], [3]. We report data from the population-based dataset of the Hungarian Case-Control Surveillance of Congenital Abnormalities (HCCSCA) [4] on the safety of nitrofurantoin in pregnancy.
Section snippets
Materials and methods
The Hungarian Congenital Abnormality Registry (HCAR) is a national-based registry of cases with congenital abnormality (CA) [5]. Notification of CAs is mandatory for physicians, and most are reported by obstetricians (in Hungary practically all deliveries occur in inpatient obstetric clinics) and pediatricians (who are working in the neonatal units of inpatient obstetric clinics and various inpatient and outpatient pediatric clinics). Autopsy was obligatory for all infant deaths and usual in
Results
During the study period, 2,146,574 babies were born in Hungary, hence 38,151 population controls represented 1.8% of the Hungarian births. In the population control group, 1079 (2.8%) pregnant women had nitrofurantoin treatment. The case group consisted of 22,865 malformed offspring and 774 (3.4%) pregnant women were treated by nitrofurantoin during pregnancy (crude OR: 1.2 with 95% CI=1.1–1.3). Of 812 patient controls, 23 (2.8%) had mothers with nitrofurantoin treatment during pregnancy (crude
Discussion
We estimated the teratogenic effect of oral nitrofurantoin treatments during pregnancy in cases with CA and in their matched controls as well as in patient controls. The critical evaluation of our data did not indicate a detectable teratogenic risk of nitrofurantoin.
The strengths of the HCCSCA are (i) the large population-based dataset; (ii) including 1876 pregnant women with oral nitrofurantoin treatment because this drug was used frequently in Hungary for the treatment of urinary tract’s
Acknowledgements
This project was supported by the EuroMap concerted action in the Biomed 2 Work programme, Contract No. BMH4-97-2430 and the Danish Medical Research Council (Grant No. 9700 677).
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