Williams Dennis
Division of Pharmacotherapy and Experimental Therapeutics, University of North Carolina at Chapel Hill, Eshelman School of Pharmacy, Chapel Hill, North Carolina 27599-7569, USA.
Consult Pharm. 2010 Nov;25(11):756-9. doi: 10.4140/TCP.n.2010.756.
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.
这一行动是长期以来对这些药物安全性的担忧和争议中的最新举措。这些变更基于美国食品药品监督管理局（FDA）对多项研究的分析，这些研究表明，使用这些疗法的哮喘患者哮喘症状会恶化，并导致住院或死亡。除了标签变更外，FDA还要求制定风险评估和缓解策略（REMS），以促进这些产品的安全使用。REMS包括一份针对患者的用药指南，以及一项针对医护人员进行长效β2受体激动剂（LABAs）合理使用教育的计划。
