A population-based case-control teratologic study of oral oxytetracycline treatment during pregnancy.
OBJECTIVE
To study human teratogenic potential of oral oxytetracycline treatment during pregnancy.


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


RESULTS
Of 38,151 pregnant women who had babies without any defects in the study period (control group), 214 (0.6%) were treated with oral oxytetracycline. Of 22,865 pregnant women who had offspring with congenital abnormalities, 216 (0.9%) were treated with oxytetracycline (OR with 95%: 1.7, 1.4-2.0). Different approaches in the study showed a higher rate of medically documented oxytetracycline treatment in the second months of gestation in neural-tube defects (OR with 95%: 9.7, 2.0-47.1), cleft palate (17.2, 3.5-83.5) and multiple congenital abnormalities (12.9, 3.8-44.3) including mainly the combination of neural-tube defects and cardiovascular malformations.


CONCLUSIONS
Treatment with oxytetracycline during the second months of pregnancy presents a teratogenic risk to the fetus.
Czeizel
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WHO Collaborating Centre for the Community Control of Hereditary Diseases, Department of Human Genetics and Teratology, National Centre for Epidemiology, Budapest, Hungary.
Rockenbauer
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M
D000014:Abnormalities, Drug-Induced / Q000453:epidemiology*; D000328:Adult; D000900:Anti-Bacterial Agents / Q000009:adverse effects*; D016022:Case-Control Studies; D002972:Cleft Palate / Q000453:epidemiology; D005260:Female; D006330:Heart Defects, Congenital / Q000453:epidemiology; D006801:Humans; D006814:Hungary; D007021:Hypospadias / Q000453:epidemiology; D016015:Logistic Models; D008297:Male; D009436:Neural Tube Defects / Q000453:epidemiology; D010118:Oxytetracycline / Q000009:adverse effects*; D011159:Population Surveillance; D011247:Pregnancy; D011248:Pregnancy Complications / Q000453:epidemiology*; D018570:Risk Assessment
D000900:Anti-Bacterial Agents; D010118:Oxytetracycline