Cardiovascular safety of drugs not intended for cardiovascular use: need for a new conceptual basis for assessment and approval
Cardiovascular safety of drugs not intended for cardiovascular use: need for a new conceptual basis for assessment and approval
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DOI：
10.1093/eurheartj/ehm209
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发表时间：
2007-08-01
影响因子：
39.3
通讯作者：
Zannad, Faiez
中科院分区：
文献类型：
--
作者：
Borer, Jeffrey S.;Pouleur, Hubert;Zannad, Faiez
最近，几种用于非心血管疾病的药物因心血管风险而停止销售，这突出了评估新药的心血管安全性的重要性，即使这些新药不适用于心血管疾病。评估和确保可接受的心血管安全性的非心血管药物是困难的，尽管如此，政府监管机构可能会改变药物安全性信息的要求。本文探讨了我们对重新思考当前监管政策的建议，强调了强制性上市后监测登记的必要性，并强调了必要的暴露，以满足对安全性问题进行更大评估的需要。
Recently, several drugs for non-cardiovascular diseases have ceased marketing because of cardiovascular risk, highlighting the importance of evaluating the cardiovascular safety of new drugs even if not intended for cardiovascular diseases. Assessing and ensuring acceptable cardiovascular safety of noncardiovascular drugs is difficult; nonetheless, governmental regulatory agencies are likely to change the requirements for drug safety information. This article explores our recommendations for rethinking current regulatory policies, emphasizing the need for mandatory post-marketing surveillance registries and highlighting the exposures necessary to subserve the need for greater assessment of safety issues.