Department of Emergency Medicine, Madigan Army Medical Center, Tacoma, USA.
Clin Toxicol (Phila). 2011 Jul;49(6):443-7. doi: 10.3109/15563650.2011.564585. Epub 2011 May 18.
The boxed warning is increasingly utilized by the Food and Drug Administration (FDA) as a clinical warning to prescribers of dangerous adverse drug reactions. As these warnings have expanded, we feel the utility and application of boxed warnings are becoming more nebulous. The use of drugs following issuance of a boxed warning has been variable. Droperidol sales decreased 10-fold in the year following the warning, yet there has been essentially no change in the methadone usage over a similar time period after its boxed warning. Including more information, such as estimation of incidence for the adverse drug reaction, would be more clinically useful to the prescriber. Reasonable standards using supplemental databases outside of the FDA (such as national poison center data) could be helpful in developing an integrated and balanced approach to boxed warnings.
方框警告越来越多地被食品和药物管理局（FDA）用作向处方医生发出危险药物不良反应的临床警告。随着这些警告的扩大，我们感到方框警告的实用性和适用性变得更加模糊。在发布方框警告后，药物的使用情况各不相同。在发出警告后的一年中，氟哌利多的销售额下降了 10 倍，但在类似的时间内，美沙酮的使用量基本上没有变化。向处方医生提供更多信息，例如不良反应的发生率估计，将更具临床意义。使用 FDA 以外的补充数据库（如国家中毒中心数据）制定合理的标准，有助于对方框警告采取综合和平衡的方法。
