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Consult Pharm. 2010 Nov;25(11):756-9. doi: 10.4140/TCP.n.2010.756.

Long-acting β₂ agonists for asthma: a clinical paradox.

Author information

1
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

Abstract

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.

PMID:
21138824
DOI:
10.4140/TCP.n.2010.756
[Indexed for MEDLINE]

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