Drug Safety Alerts

Montelukast Drug Safety Communication

3/3/2020

On March 3, 2020, the United States Food and Drug Administration (FDA) issued a drug safety communication announcing they are strengthening existing warnings about serious behavior and mood-related changes with montelukast (Singulair® and generics), which is a prescription medicine for asthma and allergy.

The FDA is taking this action after a review of available information led us to reevaluate the benefits and risks of montelukast use. Montelukast prescribing information already includes warnings about mental health side effects, including suicidal thoughts or actions; however, according to the FDA, many health care professionals and patients/caregivers are not aware of the risk. The FDA decided a stronger warning is needed after conducting an extensive review of available information and convening a panel of outside experts, and therefore determined that a Boxed Warning was appropriate.

In the communication, the FDA advised that 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. The FDA further advised that for allergic rhinitis, also known as hay fever, it has determined that montelukast should be reserved for those who are not treated effectively with or cannot tolerate other allergy medicines. For patients with asthma, the FDA recommends that health care professionals consider the benefits and risks of mental health side effects before prescribing montelukast.

The FDA recommends that health care providers 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. Warnings about these side effects are included in the existing prescribing information.

•Advise patients and parents/caregivers that the patient should 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.

•Encourage patients and parents/caregivers to read the Medication Guide they receive with their montelukast prescriptions, which explains the safety risks and provides other important information.

The FDA states that health care professionals should consider the risks and benefits of montelukast when deciding to prescribe or continue patients on the medicine. 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 those listed in the table above. 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.

CVS Caremark® Response: Please note: These products have not been recalled. CVS Caremark® Mail Service Pharmacy will continue to dispense montelukast products.

For more information about this issue, health care providers may call the FDA consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.