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2013年9月,美国FDA宣布将更改包括用于慢性疼痛治疗的各种缓释/长效阿片类镇痛药说明书,并要求生产厂商进行上市后研究。更改信息旨在控制这些药物的成瘾、滥用和误用,以及过量使用和致死危险。缓释/长效阿片类药品包括氢吗啡酮、吗啡、氧可酮、氧吗啡酮和他喷他多。对说明书的变更包括剂量、用法、警告和注意事项、药物相互作用、特定人群用法、患者咨询信息和用药指导。对缓释/长效阿片类镇痛药的风险评估与缓解策略(REMS)也将做相应修改,以反映最新
In September 2013, the U.S. FDA announced that it will make changes to various extended-release / long-acting opioid analgesics, including those for chronic pain management, and will require manufacturers to conduct post-marketing studies. The change is intended to control the addiction, abuse and misuse of these drugs as well as the dangers of overuse and lethality. Sustained-release / long-acting opioids include hydromorphone, morphine, oxycodone, oxymorphone and tapentadol. Changes to the instructions include dosages, usage, warnings and precautions, drug interactions, usage of specific populations, patient counseling information, and medication instructions. The Risk Assessment and Mitigation Strategy for Sustained-Release / Long-acting Opiate Analgesics (REMS) will also be revised to reflect the latest