Objective: The safety of drotaverin use during pregnancy is not yet proven, thus the objective of the study was the evaluation of this drug for its effect on fetal development. Method: The dataset of the Hungarian Case-Control Surveillance of Congenital Abnormalities, 1980-1991, was analyzed. Results: During the study period, 9.5% of 30 663 pregnant women who had healthy babies (negative control group), 9.4% of 17 300 pregnant women who had babies with congenital abnormalities (index patient group), and 8.0% of 667 pregnant women who had babies with Down's syndrome (positive control group), were treated with drotaverin. The main reasons for drotaverin use were threatened abortion during the second or third month and threatened preterm delivery in the last months of pregnancy. The analysis of index patient-matched control pairs did not show a higher use of drotaverin treatment among mothers of index patients with different congenital abnormality groups. The use of drotaverin was significantly lower in the group of cleft palate. Conclusion: The use of drotaverin had no detectable teratogenic effect.
|Number of pages||9|
|Journal||Prenatal and Neonatal Medicine|
|Publication status||Published - dec. 1 1996|
ASJC Scopus subject areas
- Pediatrics, Perinatology, and Child Health