The Food and Drug Administration (FDA) has upgraded to a boxed warning its previous warning about serious behavior and mood-related changes associated with the asthma drug montelukast (Singulair). The agency made this decision based on a review of submitted case reports, an observational study of FDA Sentinel System data, and observational and animal studies published in the literature.
In case reports submitted to the FDA, 82 cases of suicide were associated with montelukast use; in the 34 containing sufficient documentation, many patients had additional contributing factors of depression or self-harm. Animal studies showed that montelukast was detectable in brain tissue, proving it crossed the blood-brain barrier. The FDA's review of Sentinel System data found that various mental health adverse effects could occur with montelukast use; some disappeared after the medication was stopped but some continued.
Despite this limited new information, the FDA felt this reclassification of montelukast's warning would encourage health care providers to prescribe other approved treatments for asthma or allergies before prescribing montelukast. The agency also concluded that providers and patients did not appear to recognize the potential risk of mental health complications with montelukast. Six of the case reports specifically mentioned that providers had not given patients any information about the potential psychiatric effects of the drug.
The FDA suggests that montelukast be used to treat allergic rhinitis (hay fever) only if the patient cannot be treated with other medications. Nurses and NPs should assess patients for mental health issues prior to starting montelukast and report any adverse effects of the drug to the FDA MedWatch system: http://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-repo.
Patients and their families should stop montelukast and contact their health care provider if they experience behavior or mood-related changes (see Potential Behavior or Mood-Related Changes with Montelukast Therapy). To read the Drug Safety Communication regarding montelukast, go to http://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-boxed-warning.