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Underreporting of Hemorrhagic and Thrombotic Complications of Pharmaceuticals to the U.S. Food and Drug Administration: Empirical Findings for Warfarin Clopidogrel Ticlopidine and Thalidomide from the Southern Network on Adverse Reactions (SONAR)

机译：对美国食品和药物管理局的药物和药物血栓和血栓形成的报告：来自南方网络的WarfarinClopidogrelTiclopidine和沙利度胺对不良反应（Sonar）的实证研究

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摘要

The U.S. Food and Drug Administration's (FDA) Adverse Event Reporting System (AERS), familiarly known as “MedWatch,” is the nation's primary tool for postmarket pharmaceutical safety surveillance. This system relies on adverse events voluntarily reported by health care providers and consumers either directly to the FDA or to drug manufacturers, which are required to prepare and forward the information to the agency. Little is known about how frequently adverse events are reported. Previous estimates range from 1 to 31% depending on the event, drug, and time period. We used published incidence studies to calculate reporting rates for hemorrhage, emergency hospitalization, and venous thromboembolism (VTE) associated with four drugs. We estimated annual reporting rates of 1.07% for 33,171 emergency hospitalizations of patients older than 65 years associated with warfarin, 0.9% for 13,363 hospitalizations of clopidogrel and ticlopidine, and 1.02% for an estimated 67,200 hemorrhage cases associated with warfarin. We also estimated a 9-year reporting rate of 2.3% for VTE associated with thalidomide. The incidence of these hematologic adverse drug events is high and reporting rates are low, and near the lower boundary of the 1 to 15% range seen for other events.
机译：美国食品药品监督管理局（FDA）的不良事件报告系统（AERS），通常称为“ MedWatch”，是美国上市后药品安全监控的主要工具。该系统依赖于医疗保健提供者和消费者自愿向FDA或药品制造商自愿报告的不良事件，这些不良事件需要准备并将信息转发给该机构。关于不良事件的报道频率知之甚少。根据事件，药物和时间段，先前的估计范围为1％到31％。我们使用已发表的发病率研究来计算与四种药物相关的出血，急诊住院和静脉血栓栓塞（VTE）的报告率。我们估计，与华法林相关的65171岁以上的患者的33,171例紧急住院的年度报告率为1.07％，氯吡格雷和噻氯匹定的13,363例住院的0.9％，而与华法林相关的67,200例出血病例的1.02％。我们还估计与沙利度胺相关的VTE的9年报告率为2.3％。这些血液学不良药物事件的发生率很高，报告率很低，并且接近其他事件所见的1％至15％范围的下限。

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