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: A Georgia LawyerDulera Approved with a Black Box Warning
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.
Full post as published by A Georgia Lawyer on June 28, 2010 (boomark / email).
Cipro
The FDA is seeking to add black box warnings of the risk of tendon rupture associated with Cipro and Levaquin.
The ruptures can involve Achilles tendon, shoulder, hand, bicep or thumb tendons, and is especially increased in patients older than 60, or people who have received kidney, heart or lung transplants, as well as people on steroid therapy...
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