Safety profile of medication used during pregnancy: results of a multinational European study.

PURPOSE: The present study describes the safety profile of medications used during pregnancy across European countries and examines maternal factors associated with the use of risky medications during pregnancy.

METHODS: This study is based on a multinational, web-based study conducted in 15 European countries from October 2011 to February 2012. Information about maternal demographics, illnesses, and medication use during pregnancy was collected via an electronic questionnaire. Pregnant women and new mothers with a child less than 1-year-old could participate. The Swedish, Australian, and U.S. risk classification systems were used to evaluate medication safety. Descriptive statistics and generalized estimating equation models were used.

RESULTS: A total of 587 medications were reported by the study sample (n = 6657). Sixty-nine percent of the women used medications classified as safe, 28% used medications classified as risky, and 3% used medications with no classification available. Both socio-demographic and medical factors were associated with the use of risky medications during pregnancy. Having a chronic disorder was the factor with the strongest association with the use of risky medications during pregnancy (adjusted odds ratio = 3.99, 95% confidence interval 3.54-4.49).

CONCLUSIONS: The majority of women used medications classified as safe to use during pregnancy. However, a considerable proportion of women still used medications classified as risky. Having a chronic disorder was an important driver for using risky medications. Such use may still be appropriate when considering the woman's underlying condition. Pre-pregnancy counselling is important to ensure safe medication use for both mother and child. © 2017 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd.