Case Study: Improving Upon Prior Evidence to Impact Policy
In 2018, we conducted a large observational study examining ondansetron use in early pregnancy and risk of structural birth defects using a medical claims database. Our unique approach addressed limitations of prior epidemiological studies and addressed misclassification bias often present in administrative claims data.
We found a statistically significant increased risk of specific congenital malformations in offspring when mothers were exposed to medically administered ondansetron in the first trimester. Our research was acclaimed by other experts in the field for its outstanding study design and brought to light safety concerns regarding ondansetron use during pregnancy, leading to further investigation into this matter.
As a result of our study (and others that followed), the European Medicines Agency has changed the policy on ondansetron use in pregnancy.