An assessment of the publicly disseminated evidence of safety used in decisions to withdraw medicinal products from the UK and US markets
An assessment of the publicly disseminated evidence of safety used in decisions to withdraw medicinal products from the UK and US markets
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DOI：
10.2165/00002018-200629020-00008
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发表时间：
2006-01-01
期刊：
影响因子：
4.2
通讯作者：
Shakir, SAW
中科院分区：
文献类型：
--
作者：
Clarke, A;Deeks, JJ;Shakir, SAW
背景资料：本研究的目的是评估用于支持出于安全原因撤回药品的决定的公开传播证据，以及对危害进行系统性审查的相关影响。方法：从英国药品管理局的网站上确定了因安全原因从英国和美国市场撤回的药品（现在称为药品和保健产品管理局）和美国FDA。从每次产品撤回时与公众和医疗保健专业人士的沟通中识别出相关科学证据。根据研究设计和结果对每个产品撤回决定的证据进行分类。结果：1999-2001年期间撤回了11种产品。两种产品（18%）和两种产品（18%）的比较观察性研究引用了随机试验证据。来自自发报告的证据支持撤回8种产品（73%），其中4种产品（36%）显然仅基于自发报告撤回。只有两个产品（18%）被撤回的证据，病人相关的结果从comparative study.Conclusions：这是罕见的，证据以外的自发报告被引用支持药物撤回。产品撤回的严重影响要求提高支持此类公共卫生决策的证据水平。一旦怀疑存在重要的安全性危害，前瞻性研究可能不可行，并可能被视为不道德。前瞻性研究可以加强证据基础，并应计划在每种药物首次上市时开始。系统性综述不太可能得出与药物相关的损害证据，除非它们包括自发报告和替代结局。
Background: The objective of this study was to assess the publicly disseminated evidence used to support decisions to withdraw medicinal products for safety reasons, and related implications for the conduct of systematic reviews of harm.Methods: Medicinal products withdrawn from the UK and US markets for safety reasons were identified from websites of the UK Medicines Control Agency (now known as the Medicines and Healthcare products Regulatory Agency) and the US FDA. Related scientific evidence was identified from communications made to the public and healthcare professionals at the time of each product withdrawal. Evidence for each product withdrawal decision was classified according to study design and outcome.Results: Eleven products were withdrawn during 1999-2001. Randomised trial evidence was cited for two products (18%) and comparative observational studies for two products (18%). Evidence from spontaneous reports supported the withdrawal of eight products (73%), with four products (36%) apparently withdrawn on the basis of spontaneous reports alone. Only two products (18%) were withdrawn on evidence for a patient relevant outcome from comparative studies.Conclusions: It is rare that evidence other than spontaneous reports is cited in support of drug withdrawals. The serious implications of product withdrawal mandate the elevation of the level of evidence that supports such public health decisions. Once suspicions of important safety hazards have emerged, prospective studies may be unfeasible and may be seen as unethical. Prospective studies can strengthen the evidence base and should be planned to commence when every drug is first marketed. Systematic reviews are unlikely to elicit evidence of harm associated with a drug unless they include spontaneous reports and surrogate outcomes.