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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research

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

Step Status
Educational Content
Starts On: Fri, 2/25/22: 12:00 AM EST
Ends On: Tue, 12/31/24: 11:45 PM EST
Type: Enduring Material
Credits: 1
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.
  • Identify the spectrum of neuropsychiatric adverse events, including serious neuropsychiatric events associated
    with montelukast use.
  • List the different sources of safety data that contributed to the understanding of the risk of neuropsychiatric
    events with montelukast.
  • Describe the revised labeling recommendations for use of montelukast in patients with allergic rhinitis.
Additional Information: Review the Activity Announcement for additional details: Announcement Form

Additional Resources: Slides