Dissemination of information on potentially fatal adverse drug reactions for cancer drugs from 2000 to 2002: First results from the research on adverse drug events and reports project
Dissemination of information on potentially fatal adverse drug reactions for cancer drugs from 2000 to 2002: First results from the research on adverse drug events and reports project
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DOI：
10.1200/jco.2003.04.537
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发表时间：
2003-10-15
影响因子：
45.3
通讯作者：
Bennett, CL
中科院分区：
文献类型：
--
作者：
Ladewski, LA;Belknap, SM;Bennett, CL
目的：描述的临床表现，发生率，因果关系的证据，和传播媒体的严重癌症药物相关的药物不良反应（ADRs）报告在postmarketing setting.Methods：ADRs被称为严重的，如果他们导致死亡或严重的器官衰竭。对药品说明书（PI）修订版、所谓的致医生信函和期刊文章中的肿瘤药物ADR信息进行评价，以识别2000年至2002年报告的严重ADR。信息传播的时间和内容进行了assessed.Results：25个严重的ADR与22个肿瘤药物批准后确定。这些严重ADR中约有一半与1995年之前批准的药物有关。在医学期刊（17起ADR）、PI修订版（18起ADR）和致医生信（12起ADR）中的文章中描述了ADR。4例ADR的PI修订发生在同行评审出版物后不到1年。对于同一类别药物发生的类似ADR，这些修订通常会有所不同。7例未变更PI的ADR中有5例发生在标签外使用，美国食品药品监督管理局（FDA）政策不建议变更PI。在观察期内没有癌症药物从市场上撤回。结论：我们的研究结果表明，严重的ADR可能会被发现，只要36年后的药物获得FDA批准。这表明需要持续警惕和有效的策略来传播与癌症药物相关的ADR信息。(C)2003年，美国临床肿瘤学会。
Purpose: To describe the clinical findings, occurrence rates, causality evidence, and dissemination media for serious cancer drug-associated adverse drug reactions (ADRs) reported in the postmarketing setting.Methods: ADRs were termed serious if they resulted in death or severe organ failure. ADR information for oncology drugs from package insert (PI) revisions, so-called Dear Doctor letters, and journal articles was evaluated to identify serious ADRs reported from 2000 to 2002. Timing and content of information disseminated was assessed.Results: Twenty-five serious ADRs associated with 22 oncology drugs were identified after approval. Approximately half of these serious ADRs are associated with drugs approved before 1995. ADRs were described in articles in medical journals (17 ADRs), PI revisions (18 ADRs), and Dear Doctor letters (12 ADRs). PI revisions occurred less than 1 year after peer-reviewed publication for four ADRs. These revisions often differed for similar ADRs that occurred with drugs of the same class. Five of the seven ADRs lacking PI changes occurred with off-label use, for which PI change is not recommended by US Food and Drug Administration (FDA) policy. No cancer drug was withdrawn from the market during the observation period.Conclusion: Our findings demonstrate that serious ADRs may be discovered as long as 36 years after a drug receives FDA approval. This suggests a need for continued vigilance and efficient strategies for dissemination of information about ADRs associated with cancer drugs. (C) 2003 by American Society of Clinical Oncology.