FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs of all health care professionals and students, including physicians, physician assistants, nurses, pharmacists, and pharmacy technicians. Interact with FDA staff from a variety of divisions and learn more about the FDA and drug regulation!
On Tuesday, May 18, 2021, CDER's Office of Communication, Division of Drug Information (DDI) hosted a webinar titled: FDA Drug Topics: Safety Labeling Changes for Leukotriene Receptor Antagonists and Decisions Behind a Boxed Warning. This webinar reviewed the existing data pertaining to neuropsychiatric adverse events with montelukast use and provided 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.
View Presentation: https://collaboration.fda.gov/pwxiyom432sf/
Download Presentation Slides: Safety Labeling Changes for Leukotriene Receptor Antagonists and Decisions Behind a Boxed Warning (PDF - 2.01MB)
Activity Outline and Continuing Education Information: Safety Labeling Changes for Leukotriene Receptor Antagonists and Decisions Behind a Boxed Warning (PDF - 163KB)
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