Consultant Pharmacist Forum

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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.

Keywords: Asthma; Chronic obstructive pulmonary disease; Long-acting β2 agonists

Document Type: Research Article

DOI: http://dx.doi.org/10.4140/TCP.n.2010.756

Publication date: November 1, 2010

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