Safety Labeling Changes for Leukotriene Receptor Antagonists and Decisions Behind a Boxed Warning
Starts On: Fri, 2/25/22: 12:00 AM EST
Ends On: Tue, 12/31/24: 11:45 PM EST
Type: Enduring Material
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.
- This warning banner provides privacy and security notices consistent with applicable federal laws, directives, and other federal guidance for accessing this Government system, which includes (1) this computer network, (2) all computers connected to this network, and (3) all devices and storage media attached to this network or to a computer on this network.
- This system is provided for Government-authorized use only.
- Unauthorized or improper use of this system is prohibited and may result in disciplinary action and/or civil and criminal penalties.
- Personal use of social media and networking sites on this system is limited as to not interfere with official work duties and is subject to monitoring.
- By using this system, you understand and consent to the following:
- The Government may monitor, record, and audit your system usage, including usage of personal devices and email systems for official duties or to conduct HHS business. Therefore, you have no reasonable expectation of privacy regarding any communication or data transiting or stored on this system. At any time, and for any lawful Government purpose, the government may monitor, intercept, and search and seize any communication or data transiting or stored on this system.
- Any communication or data transiting or stored on this system may be disclosed or used for any lawful Government purpose.