The use of evidence in pharmacovigilance -: Case reports as the reference source for drug withdrawals
The use of evidence in pharmacovigilance -: Case reports as the reference source for drug withdrawals
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DOI：
10.1007/s002280100265
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发表时间：
2001-04-01
影响因子：
2.9
通讯作者：
Trilla, A
中科院分区：
文献类型：
--
作者：
Arnaiz, JA;Carné, X;Trilla, A
目的：出于安全原因从市场上撤回一种药物是一个严肃的、有时甚至是复杂的决定。方法：根据西班牙药品管理局提供的数据，对1990年1月至1999年12月期间因安全原因从西班牙市场撤出的所有药品进行鉴定。药物不良反应(ADR)按停药年份、受影响的器官/系统和据称的反应类型(Rawlins和Thompson分类)分类。对文献进行系统综述。结果：共有22种药物因安全原因退出市场。在22例病例中，有18例(82%)支持停药的证据来自个别病例报告、病例系列或随机临床试验和病例报告提供的数据的组合。肝脏反应(8例)和心脏反应(5例)占总撤药的59%(13/22)。在22例中，有10例(45%)的停药明显是由于B型反应。只有4次撤药是基于观察性研究的证据，并引入了一个对照组。结论：病例报告是出于安全原因将药物从市场上撤走的主要信息来源。有必要提高支持与意外和严重不良反应有关的药物停药过程的证据质量。使用大型数据库进行队列或嵌套病例对照分析是研究A类不良反应的最有效和最可靠的方法，在不同国家实施这类数据库可以使研究人员有效地进行这类研究，从而提高有关不良反应的信息质量。
Objective: Withdrawal of a drug from the market for safety reasons is a serious and sometimes complex decision. The scientific evidence supporting drug withdrawals in the past years is critically appraised,Methods: With data provided by the Spanish Medicines Agency, all drugs withdrawn from the Spanish market for safety reasons from January 1990 to December 1999 were identified. The adverse drug reactions (ADRs) were classified by the year of withdrawal, by the organ/system affected and by the alleged type of reaction (Rawlins and Thompson classification). A systematic review of the literature was performed.Results: A total of 22 drugs were withdrawn from the market due to safety reasons. In 18 of 22 cases (82%), the evidence supporting the drug withdrawal came from individual case reports, cases series or the combination of data provided by randomised clinical trials and case reports. Hepatic (eight cases) and cardiac (five cases) reactions accounted for 59% (13 of 22) of the total withdrawals. In 10 of 22 (45%) cases, drug withdrawal was clearly due to type-B reactions. Only four withdrawals were based on evidence from observational studies inducting a comparison group.Conclusion: Case reports are the main source of information used to withdraw a drug from the market for safety reasons. It is necessary to improve the quality of evidence supporting the withdrawal process of drugs linked to unexpected and severe ADRs. The use of large databases to perform cohort or nested case-control analyses is the most efficient and reliable method to study type-A class effect ADRs, The implementation of such databases in different countries could increase the quality of the information on ADRs by allowing researchers to conduct efficiently these type of studies.