FDA: Singulair to Get 'Black Box' Warning THURSDAY, March 5, 2020 (HealthDay News) -- Asthma and allergy drug montelukast -- sold as a generic and under the brand name Singulair -- will get a "boxed warning" over potential ties to neuropsychiatric effects, the U.S. Food and Drug Administration announced Wednesday. Available for Android and iOS devices. The agency's move Wednesday elevates that advisory to its most prominent boxed warning. FDA requires a Boxed Warning about serious mental health side effects for the asthma & allergy drug Singulair (montelukast). Montelukast was first approved by FDA in 1998. As a result, we cannot determine how likely it is that someone will experience these side effects when taking montelukast.To help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving montelukast or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.We reviewed case reports submitted to FDA, conducted an observational study using data from FDA’s We evaluated reporting trends for all neuropsychiatric adverse events associated with montelukast use reported in the We also performed a focused evaluation of completed suicides.
The drug has long carried a warning that it has been linked with an increased risk of "agitation, The agency's move Wednesday elevates that advisory to its most prominent, boxed warning. Some neuropsychiatric events may have been handled by discontinuation of the drug without a health care encounter. Asthma and allergy drug montelukast—sold as a generic and under the brand name Singulair—will get a "boxed warning" over potential ties to neuropsychiatric effects, the … Other reports indicated that mental health side effects developed or continued after stopping montelukast. Montelukast Warning Upgraded — Existing risk information not prominent enough and needs a black box, FDA decides by John Gever, Managing Editor, MedPage Today March 4, 2020 Discover home remedies and which foods may provide treatment for heartburn relief.Read more: Heartburn: Foods to Eat, Foods to Avoid MedicineNet does not provide medical advice, diagnosis or treatment. Drug Safety and Availability
Singulair, also known as montelukast, is widely used to treat allergies and asthma. "The incidence of neuropsychiatric events associated with montelukast is unknown, but some reports are serious, and many patients and health care professionals are not fully aware of these risks. ... (Singulair) after reports of severe mental health side effects prompted the agency to require a Boxed Warning on the drug. The FDA issued a black box warning for Singulair, or the generic form called montelukast sodium, after thousands of serious side effects are reported over 12 years. That's especially true for patients battling seasonal hay For such patients, Seymour said, "there are many other safe and effective medications to treat But one expert in respiratory illness said the true extent of the danger from montelukast remains unclear, because other factors might be at play. The new warning advises health care providers to "avoid prescribing "We recognize that millions of Americans suffer from "The incidence of neuropsychiatric events associated with montelukast is unknown, but some reports are serious, and many patients and health care professionals are not fully aware of these risks," Seymour added in an agency news release.The first such warning added to montelukast labeling came in 2008 after reports of Based on the committee's assessment, "the FDA determined 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," the agency said. Our analysis included only reports submitted to FDA, so there may be additional cases about which we are unaware. Lastly, the study was unable to adjust for socioeconomic status. It is important to know that people respond differently to all medicines depending on their health, the diseases they have, genetic factors, other medicines they are taking, and many other factors. 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. A black box warning (also called a boxed warning) is FDA’s strongest warning, similar to the ones used for cigarettes. Black Box Warning Added to Singulair and Montelukast Generics LabelingWe use cookies to ensure that we give you the best experience possible on our website.