Borer Jeffrey S, Pouleur Hubert, Abadie Eric, Follath Ferrenc, Wittes Janet, Pfeffer Marc A, Pitt Bertram, Zannad Faiez
Division of Cardiovascular Pathophysiology, Weill Medical College of Cornell University, 47 East 88th Street, New York, NY 10128-1152, USA.
Eur Heart J. 2007 Aug;28(15):1904-9. doi: 10.1093/eurheartj/ehm209. Epub 2007 Jul 5.
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 non-cardiovascular 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.
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，这凸显了评估新药心血管安全性的重要性，即使这些药物并非用于治疗心血管疾病。评估并确保非心血管药物具有可接受的心血管安全性颇具难度；尽管如此，政府监管机构可能会改变对药物安全信息的要求。本文探讨了我们对于重新思考现行监管政策的建议，强调了建立强制性上市后监测登记处的必要性，并突出了为更全面评估安全问题所需的暴露情况。
