Safety Labeling Changes for Leukotriene Receptor Antagonists and Decisions Behind a Boxed Warning

Description: This presentation will review the existing data pertaining to neuropsychiatric adverse events with montelukast use and will provide an overview of the decision-making framework underlying the recent labeling changes. The FDA has been aware of post-marketing reports of neuropsychiatric adverse events associated with montelukast use for over a decade. In response to continued concerns from the public, FDA recently conducted another comprehensive review and observational study using claims data in the Sentinel Distributed Database, the results of which were presented at an Advisory Committee meeting in September of 2019. After careful consideration of the available data and feedback received during the FDA Advisory Committee meeting, the FDA required a boxed warning and a revision specifically for the allergic rhinitis indication to reserve use of montelukast for patients who have an inadequate response or intolerance to alternative therapies.