First epidemiological data for venotonics in pregnancy from the EFEMERIS database.

Objective There are few published data about possible effects of veinotonics in pregnant women. The present study investigates potential adverse drug reactions of veinotonics in pregnancy. Method EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire d’Assurance Maladie) and outcomes (data from Maternal and Infant Protection Service and Antenatal diagnostic Centre). Women who delivered from 1 July 2004 to December 2007 in Haute-Garonne and were registered in the French Health Insurance Service have been included in the EFEMERIS database. We compared pregnancy outcomes and newborn health between women exposed to veinotonics during pregnancy and unexposed women. Results We found that 8998 women (24%) had received at least one prescription for venotonic agents during their pregnancy, corresponding to the period of organogenesis in 1200 cases. We compared data for these women with those for the 27,963 women for whom these drugs were not prescribed during pregnancy. The most widely used veinotonics were hesperidin, diosmin and troxerutin. Pregnancies led to 98.4% versus 93.6% of live births, 0.2% versus 0.2% of postnatal deaths and 1.6% versus 6.4% of pregnancy termination (miscarriage, ectopic pregnancy, medical termination, intrauterine death) in exposed and non-exposed groups, respectively. The risks of pregnancy termination (HR = 0.71 (0.60–0.84)) and prematurity (HR = 0.82 (0.73–0.93)) remained significantly lower in the women exposed to venotonics than in unexposed women. In the group of newborns whose mother had a prescription of veinotonics during organogenesis, 39 out of 1200 (3.4%) had a malformation versus 789 (3.0%) in the control group (ORa = 1.134 (0.873–1.472)). The risk of neonatal diseases was not increased by exposure to venotonic agents in the third trimester (4.9% versus 6.1% for the controls, ORa = 1.07 (0.95–1.20)). Conclusion We found no increased risk of adverse pregnancy outcome among women exposed to veinotonics compared with unexposed pregnant women. [ABSTRACT FROM AUTHOR]