ST LOUIS (MD Consult) - On September 24, 2010, the US Food and Drug Administration announced that Amgen is conducting a voluntary recall of certain lots of Epogen and Procrit because the vials may contain extremely thin glass flakes (ie, lamellae). The lamellae result from the interaction of the drug formulation with glass in the vials over the shelf life of the product.

The potential serious adverse events resulting from the use of a sterile injectable product with particulates by the intravenous route include embolic, thrombotic, and other vascular events, and by the subcutaneous route include foreign-body granuloma, local injection-site reactions, and increased immunogenicity. To date, no complaints or adverse events have been reported that can be directly attributed to the presence of glass lamellae.

Epogen and Procrit are indicated for the treatment of anemia related to therapy for chronic renal failure, chemotherapy, and infection with human immunodeficiency virus.

The following is a list of Epogen lots subject to the voluntary recall: http://www.mdconsult.com/das/news/body/220567301-4/drug/0/221724/1.html?pos=fdasafety

 

圣路易斯(MD Consult)——2010年9月24日，美国食品药品管理局(FDA)宣布，美国安进(Amgen)公司正在主动召回某些批次的Epogen和Procrit，起因是药瓶内可能含有极薄的玻璃碎片(即薄片)。薄片可能是由药物与过保质期的玻璃药瓶发生相互作用所产生的。静脉应用含有玻璃颗粒的无菌注射剂可能会发生的严重不良事件包括栓塞事件、血栓形成事件及其他血管事件，而经皮下注射所发生的严重不良事件包括异物肉芽肿、注射部位局部反应和免疫原性增强等。迄今，尚未收到由玻璃薄片直接引起的投诉或不良事件报告。

 

Epogen和Procrit适用于治疗由慢性肾衰、化疗和人类免疫缺陷病毒感染引起的贫血。

有关主动召回的Epogen具体批号请登录以下网址查阅：http://www.mdconsult.com/das/news/body/220567301-4/drug/0/221724/1.html?pos=fdasafety