Fluoxetine and infantile hypertrophic pylorus stenosis: A signal from a birth defects - Drug exposure surveillance study

Background: One of the objectives of a birth defects registry is to detect possible new teratogens at an early stage. A surveillance study in which combinations of specific birth defects and drugs used in the first trimester of pregnancy are systematically evaluated is one of the methods to identify possible new risk factors for malformations. Objectives: To report on an association found in such a surveillance study. Methods: The database of a population-based birth defects registry (birth years 1997-2007) was systematically screened for combinations of drugs and malformations that were disproportionately present compared to the rest of the database. Combinations with at least 3 exposed cases and a p