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 montelukast sodium could not be used safely in the OTC...