A population-based case-control teratologic study of oral oxytetracycline treatment during pregnancy

Objective: To study human teratogenic potential of oral oxytetracycline tre atment during pregnancy. Materials and Methods: The pair analysis of cases with congenital abnormalities and matched healthy controls in the large pop ulation-based dataset of the Hungarian Case-Control Surveillance of Congeni tal Abnormalities, 1980-1996. Results: Of 38,151 pregnant women who had bab ies without any defects in the study period (control group), 214 (0.6%) wer e treated with oral oxytetracycline. Of 22,865 pregnant women who had offsp ring with congenital abnormalities, 216 (0.9%) were treated with oxytetracy cline (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 sec ond 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 car diovascular malformations. Conclusion: Treatment with oxytetracycline durin g the second months of pregnancy presents a teratogenic risk to the fetus. (C) 2000 Elsevier Science Ireland Ltd. All rights reserved.