Pregnancy outcome in women exposed to dopamine agonists during pregnancy: a pharmacoepidemiology study in EFEMERIS database.

PURPOSE: The objective of this exposed-unexposed study was to evaluate potential effects of dopamine agonists during pregnancy.

METHODS: Data from EFEMERIS, a cohort of 57,408 pregnant women living in South West France, were used to compare exposed and unexposed women. The exposed group included 183 women (0.3 %) who received at least one prescription for one dopamine agonist during pregnancy. These women were individually matched with two unexposed women from the cohort for age and the month-and-year of the start of pregnancy. Pregnancy losses, birth defects, preterm births, low birth weight and psychomotor development were studied.

RESULTS: Bromocriptine was the most frequently prescribed dopamine agonist, followed by cabergoline and quinagolide. Most (75 %) of the dopamine agonists were prescribed at the beginning of pregnancy (first trimester). There was no difference between the two groups concerning pregnancy history and demographic data. After adjustment for potential confounders, prescription and dispensation of dopamine agonists was associated with an increased risk of pregnancy loss [PORa = 3.7; 95 % confidence interval (CI) 1.8-7.4] and preterm birth (PORa = 3.6; 95 % CI 1.5-8.3). The prevalence of birth defects and low birth weight was not significantly different between the two groups. No difference in psychomotor development at either 9 or 24 months was observed between the two groups.

CONCLUSION: This study suggests that prenatal exposure to dopamine agonists may be associated with an increased risk of pregnancy loss and preterm birth.