Colchicine for injection has been available in the United States since the 1950s. Although not approved by the Food and Drug Administration (FDA), intravenous (IV) cholchicine has been an accepted treatment for acute gout symptoms. Several additional IV uses have been studied, including treatment of familial Mediterranean fever, pericarditis, primary biliary cirrhosis, amyloidosis, and Behçet's syndrome. More recently, outpatient use of IV administration for chronic back pain has been advocated by alternative medicine providers but is not an accepted practice. Colchicine has well-known toxicities that limit its safe therapeutic use. IV doses that exceed the standard single-use therapeutic dose of 2--4 mg per episode of gout have resulted in life-threatening toxicity. In March 2007, two persons from Washington and Oregon died after receiving IV colchicine for back pain from an alternative medicine clinic in Oregon. This report describes the investigation, which determined that a measuring error by a Texas compounding pharmacy resulted in a fatal colchicine concentration that was eight times greater than the recognized standard level. A subsequent review of medical records revealed that a third death from colchicine toxicity in a patient treated at the Oregon clinic also occurred in March and likely was associated with the same compounding error. These deaths highlight the potential risk from use of IV colchicine for back pain and the possibly fatal consequences of measuring errors in compounding pharmacy products.

译文

注射用秋水仙碱自20世纪50年代开始在美国上市。尽管未经美国食品药品监督管理局 (FDA) 批准,但静脉注射 (IV) 胆碱已被接受治疗急性痛风症状。已研究了其他几种IV用途,包括治疗家族性地中海发热,心包炎,原发性胆汁性肝硬化,淀粉样变性和白塞氏综合征。最近,替代药物提供者提倡门诊使用IV给药治疗慢性背痛,但这并不是公认的做法。秋水仙碱具有众所周知的毒性,限制了其安全的治疗用途。超过每次痛风发作2-4 mg的标准单次使用治疗剂量的IV剂量会导致危及生命的毒性。在2007年3月,来自华盛顿和俄勒冈州的两个人在俄勒冈州的一家替代医学诊所接受IV秋水仙碱治疗背痛后死亡。该报告描述了这项调查,该调查确定德克萨斯州复合药房的测量误差导致致命的秋水仙碱浓度比公认的标准水平高八倍。随后对病历的审查显示,在俄勒冈州诊所接受治疗的患者中,因秋水仙碱毒性而死亡的第三例也发生在3月,并且可能与相同的复合误差有关。这些死亡凸显了使用IV秋水仙碱治疗背痛的潜在风险,以及复合药房产品中测量错误可能导致的致命后果。

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