FDA Black Box Warning for Montelukast Due to Risk for Neuropsychiatric Events
Learning Objectives and CME/Disclosure Information
This activity is intended for healthcare providers delivering care to women and their families.
After completing this activity, the participant should be better able to:
1. List the FDA approved indications for use of montelukast in the treatment of asthma 2. Discuss the reasons for the FDA requirement for a boxed warning and Medication Guide for montelukast
Estimated time to complete activity: 0.25 hours
Susan J. Gross, MD, FRCSC, FACOG, FACMG President and CEO, The ObG Project
Disclosure of Conflicts of Interest
Postgraduate Institute for Medicine (PIM) requires faculty, planners, and others in control of educational content to disclose all their financial relationships with ineligible companies. All identified conflicts of interest (COI) are thoroughly vetted and mitigated according to PIM policy. PIM is committed to providing its learners with high quality accredited continuing education activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of an ineligible company.
The PIM planners and others have nothing to disclose. The OBG Project planners and others have nothing to disclose.
Faculty: Susan J. Gross, MD, receives consulting fees from Cradle Genomics, and has financial interest in The ObG Project, Inc.
Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.
Method of Participation and Request for Credit
Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from 03-23-2020 through 03-21-2021, participants must read the learning objectives and faculty disclosures and study the educational activity.
If you wish to receive acknowledgment for completing this activity, please complete the post-test and evaluation. Upon registering and successfully completing the post-test with a score of 100% and the activity evaluation, your certificate will be made available immediately.
For Pharmacists: Upon successfully completing the post-test with a score of 100% and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.
Joint Accreditation Statement
In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
Physician Continuing Medical Education
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Continuing Nursing Education
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Designated for 0.2 contact hours of pharmacotherapy credit for Advance Practice Registered Nurses.
The FDA has issued a Drug Safety Communication and is requiring a ‘boxed warning’ (most prominent warning) for montelukast. The concern relates to neuropsychiatric events associated with the drug, which is used to treat asthma and allergic rhinitis (hay fever). The boxed warning advises health care providers to avoid prescribing montelukast for patients with mild symptoms, particularly those with allergic rhinitis.
FDA-approved (1998) to
Prevent asthma attacks and for long-term treatment of asthma in adults and children 1 year and older
Prevent exercise-induced asthma in patients 6 years and older
Help control the nasal symptoms of seasonal outdoor allergies in patients 2 years and older and year-round indoor allergies in those 6 months and older
Note: Montelukast is not indicated for treatment of bronchospasm in acute asthma attacks, including status asthmaticus
Method of action
Montelukast is a selective leukotriene receptor antagonist of the cysteinyl leukotriene CysLT1 receptors | Inhibits bronchoconstriction from antigen challenge
Following review, there are continuing reports of neuropsychiatric events including the following
Suicidal thoughts and actions
The FDA reassesses risks vs benefits based on these reviews and has found that
…the risks of montelukast may outweigh the benefits in some patients, particularly when the symptoms of the disease are mild and can be adequately treated with alternative therapies
For allergic rhinitis in particular, the FDA has determined that montelukast should be reserved for patients who have not responded adequately to other therapies — or who cannot tolerate these therapies
Healthcare Professional Requirements
Counsel all patients receiving montelukast about mental health side effects, and advise them to stop the medicine and contact a health care professional immediately if they develop any symptoms included but not limited to
Agitation, including aggressive behavior or hostility
Bad or vivid dreams
Disorientation or confusion
Hallucinations (seeing or hearing things that are not really there)
Suicidal thoughts and actions
Tremor or shakiness
Uncontrolled muscle movements
Ask patients about any history of psychiatric illness prior to initiating treatment
Important to monitor patients even without history of psychiatric illness | Events have occurred in patients with and without pre-existing psychiatric disease
Be aware that some patients have reported neuropsychiatric events after discontinuation of montelukast
Only prescribe montelukast for allergic rhinitis in patients who have an inadequate response or intolerance to alternative therapies
A ‘Medication Guide’ is to be given to patients with each montelukast prescription | FDA encourages healthcare professionals to encourage patients to read these guides
Side effects should be reported to FDA’s MedWatch program (healthcare professionals and patients)
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Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
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