ST LOUIS (MD Consult) - On March 17, 2010, The Medicines Company announced that it is voluntarily expanding the recall of Cleviprex (clevidipine) injectable emulsion because a potential exists that some vials contain particulate matter. According to the manufacturer, Cleviprex is an intravenous dihydropyridine calcium-channel blocker, which is used to provide rapid antihypertensive management in critical situations.

In December 2009, The Medicines Company and the US Food and Drug Administration issued a notice about a nationwide recall of 11 lots of Cleviprex for the same reason. Particulate matter that had been observed in some vials was found to be primarily composed of inert stainless steel particles of approximately 2.5 μm in diameter. Experimental animal and human data indicate that these particles are scavenged by macrophages and other cells of the reticuloendothelial system. However, the presence of these particles could theoretically reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions. Resultant reductions in blood supply to tissues could lead to ischemia or functional insufficiency in the brain, kidney, liver, heart, or lungs.

The four additional Cleviprex lots being recalled are the following:

 

·         68-407-DJ (expires 08/2010);

·         68-408-DJ (expires 08/2011);

·         71-101-DJ (expires 11/2011); and

·         71-106-DJ (expires 11/2011).

 

The affected lots of Cleviprex should be returned to the manufacturer. For medical inquiries, adverse-event reporting, or quality issues related to Cleviprex, health care professionals may contact The Medicines Company by telephone at 1-888-977-6326.

 

圣路易斯(MD Consult)——2010年3月17日，Medicines公司宣布扩大Cleviprex (丁酸氯维地平)注射用乳剂的主动召回范围，原因为一些药瓶中可能仍含有微粒物质。根据生产商报告，Cleviprex是一种静脉用二氢吡啶类钙通道阻滞剂，用于紧急状况下迅速降低血压。

2009年12月，Medicines公司与美国食品药品管理局联合发布通告，以相同原因在全国范围内召回11个批次的Cleviprex。在一些药瓶中观察到的微粒物质主要由直径约2.5 μm的惰性不锈钢微粒组成。动物试验及人体内研究资料提示，这些微粒可被巨噬细胞和网状内皮系统的其他细胞所清除。但在理论上，这些微粒的存在可减少毛细血管的血流量，从而可对某些组织造成机械性损伤，也可能引发急性或慢性炎性反应。这些微粒物质引起的组织供血减少可能导致脑、肾、肝、心脏以及肺部缺血或功能损伤。

这次宣布召回的是以下4个批次的Cleviprex：

 

·         68-407-DJ(有效期至2010年8月);

·         68-408-DJ (有效期至2011年8月);

·         71-101-DJ(有效期至2011年11月);以及

·         71-106-DJ(有效期至2011年11月)

 

应将以上受累批次的Cleviprex返还生产商。若有与Cleviprex相关的药物咨询、不良事件报告或质量问题，医护人员可致电1-888-977-6326联系Medicines公司。