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  6. Safety Labeling Changes for Leukotriene Receptor Antagonists and Decisions Behind a Boxed Warning
  1. FDA Pharmacy Student Experiential Program

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

FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present our FDA Drug Topic series of educational webinars targeting the needs of all health care professionals, including physicians, physician assistants, nurse practitioners, nurses, pharmacists, pharmacy technicians, and certified public health professionals. 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.

Instructions for Learners to complete home study activities, complete evaluation, and print certificate:

  1. Navigate to https://ceportal.fda.gov/
  2. If you have an account, please login
  3. If you do not have an account, click on “Create an account!”
  4. Once you’re logged in, please complete your profile if you haven't done so already 
  5. Navigate to the “Web-based Courses” tab
  6. Select the activity you want to complete
  7. Click on the “Enroll” button. As you complete all the steps listed in the box, a green checkmark will appear
  8. Begin the activity by clicking on the link at the bottom of the page
  9. After viewing the presentation, click on “Complete Post-test”
  10. After successful completion of the Post-test, click on “Complete Evaluation”
  11. After completion of the evaluation, you may view/print your statement of credit and/or certificate of completion  

Requirements for receiving CE credits:

Review the activity, complete the post-test and evaluation. Upon completion, learners may view or print their statement of credit.

For those of you who are pharmacists or pharmacy technicians: The FDA CE Team will report your credit to the National Association of Boards of Pharmacy—otherwise known as “NABP”—provided you add your NABP ID and date of birth to your profile in the FDA CE Portal. The only official Statement of Credit is the one you pull from CPE Monitor.  If you do not see your credit reflected on the CPE Monitor after 45 days after completion of the activity, please contact FDACETeam@fda.hhs.gov. The CPE Monitor sets a strict 60-day limit on uploading credits.

Initial release date: February 25, 2022
Expiration date: December 31, 2024

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