![]() ![]() 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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