![]() ![]() Of these, approximately 2.3 million were children younger than 17 years. In 2018, approximately 9.3 million patients of any age received a dispensed prescription for montelukast from U.S.Common side effects of montelukast include upper respiratory infection, fever, headache, sore throat, cough, stomach pain, diarrhea, earache or ear infection, flu, runny nose, and sinus infection.It is available as tablets, chewable tablets, and oral granules. Montelukast is marketed under the brand name Singulair and as generics.Montelukast blocks substances in the body called leukotrienes to help improve symptoms of asthma and allergic rhinitis.It is used to treat seasonal outdoor allergies in patients 2 years and older, and year-round indoor allergies in patients 6 months and older. Montelukast is also approved to control the symptoms of allergic rhinitis, also known as hay fever, such as sneezing, stuffy nose, runny nose, and itching of the nose. It is approved to prevent exercise-induced asthma in patients 6 years and older. It is a prescription medicine approved to prevent asthma attacks and for the long-term treatment of asthma in adults and children 1 year and older. Montelukast is FDA-approved for asthma and allergies.*The cases were reported to the FDA Adverse Event Reporting System (FAERS) database. We previously communicated about mental health side effects with montelukast in March 2008, January 2009, June 2009, and August 2009. In addition, many health care professionals and patients/caregivers are not aware of the risk of mental health side effects despite the existing warnings in the prescribing information. Due to the wide availability of alternative safe and effective allergy medicines with long histories of safety, we have reevaluated the risks and benefits of montelukast and have determined it should not be the first choice treatment particularly when allergic rhinitis symptoms are mild. 1 (See Data Summary for more information)Īlthough new data regarding the risk of mental health side effects with montelukast are limited, we decided to strengthen the warnings by requiring a Boxed Warning. We also reviewed animal studies, which showed that montelukast given orally reaches the brain in rats. However, the Sentinel study and the observational studies had some limitations which may affect how we interpret the results. The Sentinel study, which studied asthma patients 6 years and older, and other observational studies did not find an increased risk of mental health side effects with montelukast compared to inhaled corticosteroids (ICS). Other reports indicated that mental health side effects developed or continued after stopping montelukast. ![]() Some occurred during montelukast treatment and resolved after stopping the medicine. Consistent with our prior evaluations, a wide variety of mental health side effects have been reported, including completed suicides. We continue to receive reports of mental health side effects reported with montelukast use. Given the available information, we also reevaluated the benefits and risks of use of montelukast. We reviewed case reports submitted to FDA*, conducted an observational study using data from the FDA’s Sentinel System, and reviewed observational and animal studies in the published literature. For patients with asthma, we recommend that health care professionals consider the benefits and risks of mental health side effects before prescribing montelukast. For allergic rhinitis, also known as hay fever, we have determined that montelukast should be reserved for those who are not treated effectively with or cannot tolerate other allergy medicines. We 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.īecause 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. Montelukast prescribing information already includes warnings about mental health side effects, including suicidal thoughts or actions however, many health care professionals and patients/caregivers are not aware of the risk. We are taking this action after a review of available information led us to reevaluate the benefits and risks of montelukast use. Food and Drug Administration (FDA) is strengthening existing warnings about serious behavior and mood-related changes with montelukast (Singulair and generics), which is a prescription medicine for asthma and allergy. ![]()
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