[Drug Safety Communication, March 4, 2020] – FDA is strengthening existing warnings about serious behavior and mood-related changes with montelukast, which is a prescription medicine for asthma and allergy. Because of the risk of mental health side effects, the benefits of montelukast may not outweigh the risks in some patients, particularly when the symptoms of disease may be mild and adequately treated with other medicines. For allergic rhinitis, also known as hay fever, the agency advises restricting the use of montelukast to those who are not treated effectively with or cannot tolerate other allergy medicines. For patients with asthma, it recommends that health care professionals should consider the benefits and risks of mental health side effects before prescribing montelukast.
Patients should stop montelukast and discuss with a health care professional right away if they experience behavior or mood-related changes while taking the medicine. These may include:
- 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
Health care professionals should:
- Ask patients about any history of psychiatric illness prior to initiating treatment.
- Consider the risks and benefits of montelukast when deciding to prescribe or continue patients on the medicine.
- Advise all patients of the risk of neuropsychiatric events when prescribing montelukast.
- Advise patients to stop taking montelukast and contact a health care professional immediately if changes in behavior or new neuropsychiatric symptoms, suicidal thoughts or behavior occur.
- Monitor all patients treated with montelukast for neuropsychiatric symptoms. Events have occurred in patients with and without pre-existing psychiatric disease.