The Safety of Asthma Medications During Pregnancy and Lactation: Evidence Gaps and How to Fill Them

University Of California, San Diego, La Jolla CA

Investigators

Linked publications, trials & patents

Abstract

Project Summary In 2015, the U.S. Food and Drug Administration (FDA) introduced the Pregnancy and Lactation Labeling Rule, a new system that removed the pregnancy letter ratings (A,B,C,D,X) from all Prescribing Information and replaced them with a narrative summary of animal and human gestational safety data and clinical considerations. Asthma is the most common potentially serious medical problem to occur during pregnancy. The revised Prescribing Information highlights a critical need for high quality human safety data to inform the use of asthma medications during pregnancy and lactation. Randomized controlled trials in this population are not sufficiently feasible to address all evidence gaps in this population. Well-designed observational studies are needed to fill evidence gaps and guide clinical decision-making during pregnancy. Progress in the care of asthma during pregnancy requires multi-stakeholder meetings to prioritize the most important evidence gaps, including individuals with a history of asthma during pregnancy, their caregivers, clinicians, professional societies, the pharmaceutical industry, patient advocacy organizations, payers, policymakers, and research methodologists. To our knowledge, these groups do not have a formal venue in which to work together to review progress in the field, identify and prioritize research activities in the discovery and delivery sciences, and develop collaborations to fill the most important evidence gaps. The overall goal of this conference is to convene relevant stakeholders to develop a research agenda regarding the safety of asthma medications during pregnancy and lactation. We will submit for peer-reviewed publication a workshop report within 12 months of the start of the project period. More importantly, this meeting will catalyze the development of a multi-stakeholder consortium.