A population-based case-control teratologic study of nalidixic acid.
OBJECTIVE
Quinolones, mainly nalidixic acid, are frequently used in Hungary to treat bacterial infections in pregnant women, but so far no controlled epidemiological studies of congenital abnormalities among infants born to women treated with nalidixic acid during pregnancy have been reported.


METHODS
The analysis of oral nalidixic acid use during pregnancy in the mothers of cases with congenital abnormalities and in their matched population controls without congenital abnormality was carried out in the population-based dataset of the Hungarian Case-Control Surveillance of Congenital Abnormalities between 1980 and 1996. The study included 22865 women who had newborns or fetuses with congenital abnormalities, and 38151 pregnant women who had newborn infants without any defects (controls).


RESULTS
In the case group, 242 (1.1%) and in the control group, 377 (1.0%) pregnant women were treated with nalidixic acid (crude OR: 1.1 with 95% CI: 0.9-1.3). Seventeen different congenital abnormality groups were evaluated and a higher prevalence of pyloric stenosis was found in seven case infants born to mothers who received nalidixic acid treatment during the last months of pregnancy (adjusted OR: 11.0 with 95% CI: 1.3-91.4).


CONCLUSIONS
Treatment with nalidixic acid during pregnancy may increase the risk of pyloric stenosis, though the chance effects cannot be excluded.
Czeizel
A E
AE
Foundation for the Community Control of Hereditary Diseases - Department of Human Genetics and Teratology, National Center for Epidemiology, Budapest, Hungary. czeizel@mail.interware.hu
Sørensen
H T
HT
Rockenbauer
M
M
Olsen
J
J
D000014:Abnormalities, Drug-Induced / Q000453:epidemiology / Q000209:etiology*; D000328:Adult; D000890:Anti-Infective Agents / Q000009:adverse effects*; D001424:Bacterial Infections / Q000188:drug therapy; D016022:Case-Control Studies; D005260:Female; D006801:Humans; D006814:Hungary / Q000453:epidemiology; D009268:Nalidixic Acid / Q000009:adverse effects*; D011159:Population Surveillance; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy; D011263:Pregnancy Trimester, Third; D015995:Prevalence; D011707:Pyloric Stenosis / Q000139:chemically induced* / Q000151:congenital* / Q000453:epidemiology; D012042:Registries; D012307:Risk Factors; D013723:Teratogens
D000890:Anti-Infective Agents; D013723:Teratogens; D009268:Nalidixic Acid