FDA对抗高血压药品说明书增加降低血压改善心血管预后内容的要求

FDA's requirement for antihypertensive drug labeling increasing content of lowering blood pressure and improving cardiovascular outcomes

美国食品药品管理局(FDA)于2017年3月发布了"高血压适应症:药品说明书中有关心血管预后描述"的指导原则,要求抗高血压药品说明书增加有关降低血压可预防严重心血管事件的内容,详细规定了说明书适应证和临床研究项目的标准描述,其目的是促进高血压患者合理使用抗高血压药物,把血压降低到目标水平,改善预后。介绍该指导原则主要内容并列举实例,期盼我国抗高血压药生产厂家和药品监管部门能借鉴FDA的这种做法,共同努力尽快修订我国抗高血压说明书,使患者受益。

FDA issued Guidance for Industry Hypertension Indication： Drug Labeling for Cardiovascular Outcome Claims in March 2017, requires that antihypertensive drug labeling should increase the content that lowering blood pressure can prevent serious cardiovascular events, provide a standard description of the INDICATIONS AND USAGE and CLINICAL STUDIES section in labeling in detail. The aim is to encourage the rational use of antihypertensive drugs in hypertensive patients, to reduce blood pressure to the target level, and to improve the outcomes. This paper introduces the main contents of guidance and enumerates a example, and look forward to that antihypertensive drug manufacturers and drug regulatory authorities can learn from this practice of FDA, and work together to revise antihypertensive drug labeling as soon as possible in our country, so as to benefit patients.