ST LOUIS (MD Consult) - On May 25, 2010, the US Food and Drug Administration (FDA) announced that Ortho-McNeil-Janssen has made changes to the Warnings section of the prescribing information for Ultram (tramadol), a centrally acting synthetic opioid analgesic indicated for the management of moderate to moderately severe chronic pain. The strengthened Warnings information emphasizes the risk of suicide for patients who are addiction prone and for patients who may be taking tranquilizers or antidepressant drugs. The risk of overdosage is also highlighted in the updated label.

 

Tramadol-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation or attempts, as well as in patients with histories of misuse of tranquilizers, alcohol, and other drugs that act within the central nervous system (CNS). Tramadol may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause CNS depression. Serious potential consequences of overdosage with tramadol are CNS depression, respiratory depression, and death. Tramadol has mu-opioid–agonist activity. The drug can be abused and may be subject to criminal diversion.

Patients receiving tramadol should be warned not to exceed recommended doses. They should also be cautioned about the concomitant use of tramadol products and alcohol. Moreover, they should be advised of the additive effects that occur when Ultram is taken with other drugs that cause CNS depression.

 

圣路易斯(MD Consult)——2010年5月25日，美国食品药品管理局(FDA)宣布，Ortho-McNeil-Janssen已对Ultram(曲马多)处方说明的警告部分做了更改，该药是一种作用于中枢的合成型阿片类止痛药，适用于控制中、重度慢性疼痛。强调后的警告说明重点为有成瘾倾向的患者及可能在服用镇静剂或抗抑郁药的患者有自杀风险。用药过量的风险在最新说明书中亦得到强调。

在既往有情感障碍或自杀意念或企图史的患者以及有镇静剂、酒精及其他作用于中枢神经系统(CNS)药物滥用史的患者中已发生了曲马多相关的死亡事件。据推测，曲马多与酒精、其他阿片类药物或可引起CNS抑制的违禁药物联用时可能具有叠加效应。曲马多过量可能导致的严重后果为CNS抑制、呼吸抑制以及死亡。曲马多有μ-阿片受体激动剂活性。该药有滥用可能，并可能用于犯罪性消遣。

 

应警告收到曲马多的患者用药量切勿超过推荐剂量，同时还应提醒其在配伍应用曲马多药品和饮酒时应慎重。此外，还应告知他们在与其他引起CNS抑制的药物同服曲马多时可能会发生叠加效应。