Off-label asthma/peds use concerns FDA for Singulair allergy OTC switch
This article was originally published in Scrip
Executive Summary
Merck is requesting the FDA switch the allergies indication for Singulair (montelukast), a leukotriene receptor antagonist, from prescription to over-the-counter (OTC) for US adults 18 or older, but regulators raised concerns the nonprescription status could result in patients with asthma using the product off-label to self-treat rather than seeking care from a healthcare provider for their condition.