为了更合理地使用阿片类镇痛药，2013年1月美国食品药品监督管理局（FDA）公布了“防滥用的阿片类药物——评价和说明书”指导原则（草案），2014年4月FDA发布了给缓释/长效（ER/LA）阿片类药物申请书持有者的公开信。概要介绍这两个文件中对防滥用阿片类药物说明书的防滥用性质描述的要求，对ER/LA阿片类药物安全性资料更新的要求，希望通过这两个文件对我国药品生产企业相应说明书的起草和更新有所启发和帮助，防止药物滥用及不良反应。

In order to rationally use opioid analgesics, FDA released the “Guidance for Industry Abuse-Deterrent Opioids-Evaluation and Labeling-Draft” in January, 2013 and issued an open letter to ER/LA opioid application holders in April, 2014, which introduces the requirements for the descriptions of abuse-deterrent properties in abuse-deterrent opioid labeling in the guidance. The requirements for the ER/LA opioid analgesics safety labeling change in the letter are introduced in this paper. It is expected that the two new requirements of FDA on the labeling are helpful to the drug production enterprises drafting and updating the corresponding labeling and also have the inspiration to the drug regulatory organizations in our country.