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.

• U.S. Food and Drug Administration. FDA Briefing Materials for the September 27, 2019 Joint Meeting of the Pediatric and Drug Safety and Risk Management Advisory Committees. https://www.fda.gov/media/131035/download.
• U.S. Food and Drug Administration. Transcript of the September 27, 2019 Joint Meeting of the Pediatric and Drug Safety and Risk Management Advisory Committees. https://www.fda.gov/media/132560/download.
• U.S. Food and Drug Administration. "FDA requires Boxed Warning about serious mental health side effects fr asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis." FDA Drug Safety Communication. March 4, 2020. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-boxed-warning-about-serious-mental-health-side-effects-asthma-and-allergy-drug.
• Sansing-Foster V, Haug N, Mosholder A, Cocoros NM, Bradley M, Ma Y, et al. Risk of Psychiatric Adverse Events Among Montelukast Users. J Allergy Clin Immunol Pract. 2021;9(1):385-93.e12.
• Chin S, Clarridge K, Eworuke E, Seymour S. A Boxed Warning for Montelukast: The FDA Perspective The Journal of Allergy and Clinical Immunology: In Practice. 2021. In Press.

• 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.

Physicians, physician assistants, pharmacists, nurses, pharmacist techs, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

• CLARRIDGE, KATHERINE, MD, Medical Officer, FDA - nothing to disclose

• Burke, Kara, PharmD, Team Leader/Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
• Cao, Christian, MPAS, PA-C, Cross-Discipline Safety Advisor, FDA/CDER/OSE/OPE - nothing to disclose
• De Fronzo, Kimberly, RPh, MS, MBA, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose
• Kapoor, Rama, MD, Senior Physician, FDA - nothing to disclose
• Nguyen-Chu, Thanh, PharmD, Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
• Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose

• Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose

Initial Release Date
February 25, 2022

Expiration Date
December 31, 2024