Panel Recommends Against OTC <em>Singulair </em>Due To Off-Label Use Risk

Panel Recommends Against OTC Singulair Due To Off-Label Use Risk

02 May 2014

• By Elizabeth Crawford

FDA’s Nonprescription Drug Advisory Committee votes against recommending approval after weighing the risks and benefits of switching Merck’s Singulair Allergy 10 mg montelukast sodium for allergy relief.

A panel of experts discouraged FDA from switching Merck & Co. Inc.’s Singulair Allergy from Rx to OTC because the risk of off-label use and neuropsychiatric adverse events do not outweigh the “modest” benefit of allergy relief.

At a May 2 meeting of FDA’s Nonprescription Drug Advisory Committee, 11 of the 15 members voted that 10 mg...