Klontz Karl C, DeBeck Heidi J, LeBlanc Pamela, Mogen Kathryn M, Wolpert Beverly J, Sabo Jonathan L, Salter Monique, Seelman Sharon L, Lance Susan E, Monahan Caitlin, Steigman David S, Gensheimer Kathleen
U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Analytics and Outreach, College Park, MD.
U.S. Food and Drug Administration, Office of Foods and Veterinary Medicine, Coordinated Outbreak Response and Evaluation Network, College Park, MD.
Public Health Rep. 2015 Sep-Oct;130(5):526-32. doi: 10.1177/003335491513000515.
Liver disease is a potential complication from using dietary supplements. This study investigated an outbreak of non-viral liver disease associated with the use of OxyELITE Pro(TM), a dietary supplement used for weight loss and/or muscle building.
Illness details were ascertained from MedWatch reports submitted to the U.S. Food and Drug Administration (FDA) describing consumers who ingested OxyELITE Pro alone or in combination with other dietary supplements. FDA's Forensic Chemistry Center analyzed samples of OxyELITE Pro.
From February 2012 to February 2014, FDA received 114 reports of adverse events of all kinds involving consumers who ingested OxyELITE Pro. The onset of illness for the first report was December 2010 and for the last report was January 2014. Thirty-three states, two foreign nations, and Puerto Rico submitted reports. Fifty-five of the reports (48%) described liver disease in the absence of viral infection, gallbladder disease, autoimmune disease, or other known causes of liver damage. A total of 33 (60%) of these patients were hospitalized, and three underwent liver transplantation. In early 2013, OxyELITE Pro products entered the market with a formulation distinct from products sold previously. The new formulation replaced 1,3-dimethylamylamine with aegeline. However, the manufacturer failed to submit to FDA a required "new dietary ingredient" notice for the use of aegeline in OxyELITE Pro products. Laboratory analysis identified no drugs, poisons, pharmaceuticals, toxic metals, usnic acid, N-Nitroso-fenfluramine, pyrrolizidine alkaloids, aristocholic acid, or phenethylamines in the products.
Vigilant surveillance is required for adverse events linked to the use of dietary supplements.
肝脏疾病是使用膳食补充剂可能引发的并发症。本研究调查了一起与使用OxyELITE Pro（一种用于减肥和/或增肌的膳食补充剂）相关的非病毒性肝脏疾病暴发事件。
从提交给美国食品药品监督管理局（FDA）的MedWatch报告中确定疾病详情，这些报告描述了单独服用OxyELITE Pro或与其他膳食补充剂联合服用的消费者。FDA法医化学中心对OxyELITE Pro的样本进行了分析。
2012年2月至2014年2月，FDA收到114份涉及服用OxyELITE Pro的消费者的各类不良事件报告。第一份报告的发病时间为2010年12月，最后一份报告的发病时间为2014年1月。33个州、两个外国和波多黎各提交了报告。其中55份报告（48%）描述了在无病毒感染、胆囊疾病、自身免疫性疾病或其他已知肝损伤原因的情况下出现的肝脏疾病。这些患者中共有33例（60%）住院治疗，3例接受了肝移植。2013年初，OxyELITE Pro产品进入市场，其配方与之前销售的产品不同。新配方用aegeline替代了1,3 - 二甲基戊胺。然而，制造商未向FDA提交关于在OxyELITE Pro产品中使用aegeline的所需“新膳食成分”通知。实验室分析在产品中未发现药物、毒物、药品、有毒金属、扁枝衣酸、N - 亚硝基芬氟拉明、吡咯里西啶生物碱、马兜铃酸或苯乙胺。
对于与使用膳食补充剂相关的不良事件需要进行警惕的监测。
