Willy Mary E, Li Zili
Office of Drug Safety, Food and Drug Administration, Rockville, MD 20857, USA.
Pharmacoepidemiol Drug Saf. 2004 Apr;13(4):201-6. doi: 10.1002/pds.856.
The objective of this study was to evaluate the informativeness and consistency of product labeling of hepatotoxic drugs marketed in the United States.
We searched the Physicians' Desk Reference-2000 for prescription drugs with hepatic failure and/or hepatic necrosis listed in the labeling. We used a six-item checklist to evaluate the 'informativeness' and consistency of the labeling content. An informativeness score equaled the proportion of checklist items present in each drug's labeling.
Ninety-five prescription drugs were included in the study. Eleven (12%) of the drugs had information related to hepatic failure in a Black Boxed Warning, 52 (54%) in the Warnings section and 32 (34%) in the Adverse Reactions section of the label. The mean informativeness score was 35%; the score was significantly higher, 61%, when the risk was perceived to be high. The informativeness of labeling was not affected by the time of the labeling, but differed across the Center for Drug Evaluation and Research (CDER) Review Division responsible for the labeling.
The information provided in labeling is variable and affected by many factors, including the perceived level of risk and review division strategy. Product labeling may benefit from current FDA initiatives to improve the consistency of risk-related labeling.
本研究的目的是评估在美国上市的肝毒性药物产品标签的信息性和一致性。
我们在《医师案头参考-2000》中搜索标签中列出有肝衰竭和/或肝坏死的处方药。我们使用一份六项清单来评估标签内容的“信息性”和一致性。信息性得分等于每种药物标签中出现的清单项目的比例。
95种处方药纳入研究。其中11种（12%）药物在黑框警告中有与肝衰竭相关的信息，52种（54%）在警告部分，32种（34%）在标签的不良反应部分。平均信息性得分为35%；当风险被认为较高时，得分显著更高，为61%。标签的信息性不受标签时间的影响，但因负责标签的药品评价和研究中心（CDER）审评部门而异。
标签中提供的信息各不相同，且受许多因素影响，包括感知的风险水平和审评部门策略。产品标签可能会受益于美国食品药品监督管理局（FDA）当前为提高风险相关标签的一致性而采取的举措。
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