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First epidemiological data for venotonics in pregnancy from the EFEMERIS database
Isabelle Lacroix1, Anna-Belle Beau2, Caroline Hurault-Delarue2
1Service de Pharmacologie Clinique, CHU de Toulouse, Université de Toulouse, Toulouse isabelle.lacroix@univ-tlse3.fr.
Phlebology
|June 11, 2015
Summary
This study found no increased risk of adverse pregnancy outcomes for pregnant women using veinotonics. Veinotonics were associated with lower risks of pregnancy termination and prematurity.
Area of Science:
- Pharmacovigilance
- Obstetrics
- Perinatology
Background:
- Limited data exist on veinotonic safety during pregnancy.
- Veinotonics are commonly prescribed for venous insufficiency.
- Assessing adverse drug reactions in pregnancy is crucial for maternal and fetal health.
Purpose of the Study:
- To investigate potential adverse drug reactions associated with veinotonic use in pregnant women.
- To compare pregnancy outcomes and newborn health between women exposed and unexposed to veinotonics.
Main Methods:
- Utilized the EFEMERIS database, integrating drug prescriptions and pregnancy outcomes.
- Included women who delivered between July 2004 and December 2007 in Haute-Garonne.
- Compared outcomes for 8,998 women exposed to veinotonics with 27,963 unexposed women.
Main Results:
- Veinotonics, including hesperidin, diosmin, and troxerutin, were used by 24% of pregnant women.
- Exposed women showed significantly lower risks of pregnancy termination (HR=0.71) and prematurity (HR=0.82).
- No increased risk of malformations (ORa=1.134) or neonatal diseases (ORa=1.07) was observed.
Conclusions:
- No increased risk of adverse pregnancy outcomes was found in women exposed to veinotonics.
- Veinotonic use during pregnancy appears safe regarding major adverse outcomes.
- Further research may explore specific veinotonic agents and their long-term effects.
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