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FDA panel snubs 'partial' Rx-to-OTC switch for Merck's Singulair

 
• By Donna Young

The FDA's Nonprescription Drugs Advisory Committee (NDAC) on 2 May advised against permitting Merck to market Singulair (montelukast), a leukotriene receptor antagonist, as an over-the-counter (OTC) medicine for US adults 18 or older to treat allergies – raising concerns patients with asthma of all ages, including pediatrics, would be tempted to use the product off-label to self-treat rather than seeking the care of a physician for their condition.

The FDA's Nonprescription Drugs Advisory Committee (NDAC) on 2 May advised against permitting Merck to market Singulair (montelukast), a leukotriene receptor antagonist, as an over-the-counter (OTC) medicine for US adults 18 or older to treat allergies – raising concerns patients with asthma of all ages, including pediatrics, would be tempted to use the product off-label to self-treat rather than seeking the care of a physician for their condition.

Many on the NDAC also were concerned about reports of adverse neuropsychiatric events – agitation, aggressive behavior or hostility, anxiousness,...

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