Teratogenic effect of hydroxyethylrutoside, a flavonoid derivate drug – a population-based case–control study

Abstract

Objective: Hydroxyethylrutoside (HER), a flavonoid derivate drug, used frequently in pregnant women for the treatment of vascular diseases. The aim of this case–control study was to evaluate the teratogenic potential of oral HER treatment in the population-based Hungarian Case–Control Surveillance System of Congenital Abnormalities.

Methods: Comparative analysis of exposure (HER treatment) during pregnancy in the mothers of cases with congenital abnormalities and matched control newborns without any defect in the population-based Hungarian Case–Control Surveillance System of Congenital Abnormalities.

Results: Of the 22 843 cases with congenital abnormalities, 567 (2.5%) had mothers with HER treatment while of 38 151 matched controls, 1143 (3.0%) were born to mothers with HER treatment (OR with 95% CI: 0.8, 0.7–0.9). However, an association of HER treatment during the second and/or third month of pregnancy was found with the higher risk of unilateral ocular coloboma (OR with 95% CI: 5.4, 2.2–12.9) and a new congenital abnormality syndrome including anotia/microtia, poly/syndactyly and caudal (genital and anal) defects (OR with 95% CI: 3.0, 1.3–27.4).

Conclusions: Oral HER treatment during early pregnancy associates with a higher risk for ocular coloboma and for a newly delineated congenital abnormality syndrome.

• Congenital abnormalities
• hydroxyethylrutoside
• new congenital abnormality syndrome
• ocular coloboma
• population-based case–control study
• pregnancy

Acknowledgements

The authors thank Erzsébet H. Puho for her help in the statistical analysis of data.