SUMMARY:

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.

Montelukast

• 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

Drug Safety

• Following review, there are continuing reports of neuropsychiatric events including the following
  • Agitation
  • Depression
  • Sleeping problems
  • 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
  • Attention problems
  • Bad or vivid dreams
  • Depression
  • Disorientation or confusion
  • Feeling anxious
  • Hallucinations (seeing or hearing things that are not really there)
  • Irritability
  • Memory problems
  • Obsessive-compulsive symptoms
  • Restlessness
  • Sleepwalking
  • Stuttering
  • Suicidal thoughts and actions
  • Tremor or shakiness
  • Trouble sleeping
  • 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)

Learn More – Primary Sources

FDA Requires Stronger Warning About Risk of Neuropsychiatric Events Associated with Asthma and Allergy Medication Singulair and Generic Montelukast