ObjectivesThe United States Food and Drug Administration (FDA) implemented the Pregnancy and Lactation Labeling Rule (PLLR) in 2015, with new requirements for data in prescription drug labeling. Our purpose is to explore the extent and type of pregnancy and lactation data of newly approved prescription drugs and assess if the presented recommendations are data driven.
Study designIn this descriptive analysis, we reviewed pregnancy and lactation data of all new molecular entities (NMEs) approved between 2001 to 2020 in their most updated labeling. Information was collected regarding the pregnancy and lactation risk statements, the source of pregnancy and lactation data, and the design and methods of pregnancy and lactation studies in the labeling.
ResultsOf the 422 NMEs, the key advisory statement for use of 133 (32%) drugs in pregnancy and 194 (46%) drugs in lactation were classified as "against use." Less than 2% of all drugs had a key advisory statement that supported their use during pregnancy or lactation. The sources of data regarding use in pregnancy were studies in human and animals in 46 (11%) and 348 (82%) drugs, respectively. For use during lactation, data included studies in human and animals in 23 (5%) and 251 (59%) drugs, respectively. The key advisory recommendation was consistent with the available human information in 4 (8%) drugs in pregnancy and 3 (13%) drugs in lactation.
ConclusionsPrescription drug labeling contains limited data to support informed decision making for the use of prescription drugs during pregnancy/lactation. Close collaboration among stakeholders is required to enhance the availability of data in this population.