Partial
Partially Aligned
Patient Risk:
Moderate
Summary
Some elements of the boxed warning content (types of serious neuropsychiatric events and the need to discontinue for new NP symptoms/suicidal thoughts/behavior) are supported by the provided label excerpts, but many additional regulatory, timing, evidentiary, and clinical course details are not supported by the supplied text.
Category Scores
Accurate Statements
Montelukast carries a boxed warning for serious neuropsychiatric events.
WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS; also referenced by 6.2 Postmarketing Experience as [see Boxed Warning, Warnings and Precautions (5.1)].
Serious neuropsychiatric events reported with montelukast include agitation.
WARNING lists agitation; 6.2 lists agitation/aggressive behavior.
Serious neuropsychiatric events reported with montelukast include aggression.
WARNING lists aggression; 6.2 includes aggressive behavior/hostility.
Serious neuropsychiatric events reported with montelukast include irritability.
6.2 lists irritability; WARNING includes agitation/aggression/depression/suicidal thoughts/behavior and other NP symptoms.
Serious neuropsychiatric events reported with montelukast include depression.
WARNING lists depression; 6.2 lists depression.
Serious neuropsychiatric events reported with montelukast include suicidal thoughts or actions.
WARNING includes suicidal thoughts and behavior (including suicide); 6.2 includes suicidal thinking and behavior.
The boxed warning includes serious neuropsychiatric events beyond suicidal thoughts or actions.
WARNING lists multiple event types beyond suicidal thoughts/behavior, including agitation, aggression, depression, and sleep disturbances; 6.2 includes additional psychiatric disorders (e.g., hallucinations, insomnia, irritability).
Unsupported Statements
The FDA added the boxed warning for montelukast in 2020.
Provided label excerpts do not state FDA addition date; 'Revised: 08/2020' is not evidence of when the boxed warning was added.
The FDA added the warning after reviewing reports of completed suicides and severe behavioral changes in adults and children.
No provided label text describes the regulatory review rationale or that it was based on completed suicides and severe behavioral changes in adults/children.
Nightmares are listed in the prescribing information for montelukast.
Provided excerpts list 'sleep disturbances' and 'dream abnormalities' but do not explicitly mention 'nightmares.'
Vivid dreams appear in the prescribing information for montelukast.
Provided excerpts do not explicitly mention 'vivid dreams' (only 'dream abnormalities' are listed).
Rare cases of hallucinations have been reported to the FDA adverse event database.
Provided excerpts list hallucinations in postmarketing experience but do not state 'rare cases' or that reporting was to the FDA adverse event database.
Hallucinations reported with montelukast may be visual.
No provided label text specifies hallucination modality (visual).
Hallucinations reported with montelukast may be auditory.
No provided label text specifies hallucination modality (auditory).
Most patients see improvement within days to weeks after stopping montelukast.
No provided label text provides time-to-improvement after stopping.
Some cases take months to resolve completely after stopping montelukast.
No provided label text provides time-to-resolution after stopping.
Symptoms may take longer to resolve completely if they were misdiagnosed as a separate psychiatric disorder.
No provided label text discusses misdiagnosis affecting resolution time.
Doctors usually instruct patients to stop montelukast immediately if depression develops on montelukast.
Label advises discontinuation when changes/new NP symptoms or suicidal thoughts/behavior occur, but provided excerpts do not explicitly state 'if depression develops' nor use 'doctors usually' framing.
Follow-up care for depression after discontinuing montelukast may include mental health evaluation and monitoring for at least a week after discontinuation.
Provided excerpts instruct patients to discontinue and contact a healthcare provider immediately, but do not specify mental health evaluation or monitoring duration (e.g., 'at least a week').
Some patients may require temporary antidepressant treatment after discontinuing montelukast.
No provided label text mentions antidepressant treatment after discontinuation.
A decision to add the boxed warning was made after a review of post-marketing data showing consistent reports of serious events.
No provided label text describes the decision-making process or that it was based on consistent post-marketing reports.
The serious events reviewed for montelukast included 82 completed suicides.
No provided label text includes numeric details such as '82 completed suicides.'
Contradictions
Important Omissions
The provided label excerpts advise discussing benefits/risks with patients/caregivers and alerting them to changes in behavior/new NP symptoms; the extracted claims do not mention this counseling content.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Moderate
While event types and the general boxed-warning discontinuation/contact guidance are broadly aligned, multiple unsupported claims add specific course/timing, regulatory evidence basis, and monitoring/treatment instructions not contained in the provided label excerpts. These could mislead about expectations and management after discontinuation.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Low |
Recommendation
Partially Aligned
Primary Issue
Many extracted claims include details (year of addition, regulatory rationale, numerical counts, hallucination modality, and time-to-resolution/monitoring) that are not supported by the provided label text.
Suggested Improvement
Restrict claims to text explicitly present in the provided label excerpts (e.g., listed NP event types and the instruction to discontinue and contact a healthcare provider immediately for new NP symptoms or suicidal thoughts/behavior), and remove unsupported specificity not found in the label.