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Summary

Description
English: A boxed warning required since 2020, strengthened from a regular warning issued in 2009, for montelukast (listed as brand name Singulair) due to continually receiving reports of neuropsychiatric events, including suicide. These warnings have been used since 1979.

WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS

Serious neuropsychiatric (NP) events have been reported with the use of SINGULAIR. The types of events reported were highly variable, and included, but were not limited to, agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior (including suicide). The mechanisms underlying NP events associated with SINGULAIR use are currently not well understood [see Warnings and Precautions (5.1)].

Because of the risk of NP events, the benefits of SINGULAIR may not outweigh the risks in some patients, particularly when the symptoms of disease may be mild and adequately treated with alternative therapies. Reserve use of SINGULAIR for patients with allergic rhinitis who have an inadequate response or intolerance to alternative therapies [see Indications and Usage (1.3)]. In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and risks before prescribing SINGULAIR.

Discuss the benefits and risks of SINGULAIR with patients and caregivers when prescribing SINGULAIR. Advise patients and/or caregivers to be alert for changes in behavior or new NP symptoms when taking SINGULAIR. If changes in behavior are observed, or if new NP symptoms or suicidal thoughts and/or behavior occur, advise patients to discontinue SINGULAIR and contact a healthcare provider immediately [see Warnings and Precautions (5.1)].

See here for more information.
Date
Source Page 73 from FDA Drug Topics: Safety Labeling Changes for Leukotriene Receptor Antagonists and Decisions Behind a Boxed Warning, originally a raster and recreated as an SVG. Any mentions of Singulair were blurred since it is a registered trademark of Merck & Co.
Author Food and Drug Administration
Permission
(Reusing this file)

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Captions

Boxed warning for montelukast about adverse mental health side effects

Items portrayed in this file

depicts

montelukast

Singulair

File history

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Date/TimeThumbnailDimensionsUserComment
current01:10, 22 December 2023Thumbnail for version as of 01:10, 22 December 20231,471 × 780 (951 KB)BeywheelzLetItRipFixed missing parentheses
08:36, 21 December 2023Thumbnail for version as of 08:36, 21 December 20231,471 × 780 (950 KB)BeywheelzLetItRipUploaded a work by {{w|Food and Drug Administration}} from Page 73 from [https://www.fda.gov/media/148762/download FDA Drug Topics: Safety Labeling Changes for Leukotriene Receptor Antagonists and Decisions Behind a Boxed Warning], originally a raster and recreated as an SVG with UploadWizard
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