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