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.