Brigham & Women's Hospital, 850 Boylston Street, Chestnut Hill, MA 02467, USA.
Pain Med. 2010 Mar;11(3):369-78. doi: 10.1111/j.1526-4637.2010.00811.x.
Opioid/acetaminophen combination products are widely prescribed for the management of moderate to moderately severe pain. Acetaminophen, when improperly used, can lead to liver damage and even acute liver failure. In June 2009, an FDA advisory committee recommended elimination of prescription acetaminophen combination products because of the risk of hepatotoxicity associated with use of these medications. The FDA advisory committee reviewed numerous observational studies and adverse event reporting data. The aims of this article are to: 1) provide a summary and epidemiologic critique of the studies and evidence the FDA advisory committee reviewed; 2) examine the potential consequences, such as poorly managed pain or a shift to treatment with other medications with greater potential toxicity and/or restricted availability, if the FDA follows the advisory committee vote; and 3) outline alternate strategies the FDA should consider for reducing hepatotoxicity associated with opioid/acetaminophen combination products.
阿片类药物/对乙酰氨基酚复方制剂被广泛用于治疗中度至重度疼痛。如果使用不当，对乙酰氨基酚会导致肝损伤甚至急性肝衰竭。2009 年 6 月，FDA 顾问委员会建议淘汰处方用对乙酰氨基酚复方制剂，因为这些药物的使用与肝毒性风险有关。FDA 顾问委员会审查了大量观察性研究和不良事件报告数据。本文的目的是：1）总结和评估 FDA 顾问委员会审查的研究和证据；2）如果 FDA 遵循顾问委员会的投票结果，检查潜在的后果，例如疼痛管理不善或转向使用其他毒性更大和/或可用性更受限制的药物；3）概述 FDA 应考虑的减少阿片类药物/对乙酰氨基酚复方制剂相关肝毒性的替代策略。
