為了更合理地使用阿片類鎮(zhèn)痛藥，2013年1月美國食品藥品監(jiān)督管理局（FDA）公布了“防濫用的阿片類藥物——評價和說明書”指導(dǎo)原則（草案），2014年4月FDA發(fā)布了給緩釋/長效（ER/LA）阿片類藥物申請書持有者的公開信。概要介紹這兩個文件中對防濫用阿片類藥物說明書的防濫用性質(zhì)描述的要求，對ER/LA阿片類藥物安全性資料更新的要求，希望通過這兩個文件對我國藥品生產(chǎn)企業(yè)相應(yīng)說明書的起草和更新有所啟發(fā)和幫助，防止藥物濫用及不良反應(yīng)。

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.