Merck Singulair Allergy Switch Must Address Neuropsychiatric Concerns
This article was originally published in The Tan Sheet
Executive Summary
FDA will ask the Nonprescription Drug Advisory Committee May 2 to weigh the risks and benefits of switching Merck’s Singulair Allergy 10 mg montelukast sodium for allergy relief. Among the agency’s concerns about potential neuropsychiatric events and off-label use by children and asthmatics.