Monday, June 28, 2010

Dulera Approved with a Black Box Warning

FDA approved Merck's Dulera, a combination inhaler, for asthma patients 12 years and older.

Dulera consists of an inhaled corticosteroid and a long-acting beta agonist, and shares an active ingredient with Merck's Asmanex and Nasonex (mometasone furoate), and Foradil (formoterol fumarate). Dulera carries FDA's most severe safety warning, the black box label, which in this case warns patients about the potential for asthma-related death associated with long-acting beta agonists, or LABAs.

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