Long-acting β₂ agonists for asthma: a clinical paradox.
This action is the most recent in a long history of concerns and controversies about the safety of these agents. The changes are based on FDA's analyses of studies that demonstrated a worsening of asthma symptoms and resulting in hospitalization or death in asthma patients using the therapies. In addition to the labeling changes, FDA also requires a risk evaluation and mitigation strategy (REMS) to facilitate the safe use of the products. REMS includes a medication guide for patients and a plan to educate health care professionals about the appropriate use of LABAs.
Division of Pharmacotherapy and Experimental Therapeutics, University of North Carolina at Chapel Hill, Eshelman School of Pharmacy, Chapel Hill, North Carolina 27599-7569, USA. dwilliams@unc.edu
Dennis
D
Williams
D000280:Administration, Inhalation; D000293:Adolescent; D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D002648:Child; D003692:Delayed-Action Preparations; D004348:Drug Labeling; D004359:Drug Therapy, Combination; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration
D058666:Adrenergic beta-2 Receptor Agonists; D018927:Anti-Asthmatic Agents; D003692:Delayed-Action Preparations