FDA Requires Boxed Warning on Singulair

The FDA required a boxed warning for the allergy medicine Singulair (montelukast) and its generic formulations to strengthen existing warnings about the risk of neuropsychiatric events.

The upgraded warning comes after the agency reviewed data on continued reports of neuropsychiatric events with montelukast, including agitation, depression, sleeping problems and suicidal thoughts and actions. The drug’s labeling was previously updated in 2008 to include information about these reported events.

The warning advises health care providers to avoid prescribing montelukast for patients with mild symptoms, particularly those with allergic rhinitis. The agency is also requiring a new medication guide to be included with each montelukast prescription.