ST LOUIS (MD Consult) - On December 16, 2009, The Medicines Company and the US Food and Drug Administration announced a voluntary recall of 11 lots of Cleviprex (clevidipine butyrate) injectable emulsion. The recall is being conducted because visible particulate matter was observed in some vials of the product during a routine annual inspection. The Medicines Company has not received any product complaints or reports of adverse events related to this issue.
Cleviprex is used to reduce blood pressure in cases of acute hypertension when oral therapy is not feasible or desirable.
The affected Cleviprex lots are the following:
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61-978-DW, 61-979-DW, and 61-980-DW (expire 01/2010);
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68-404-DJ, 68-405-DJ, and 68-406-DJ (expire 08/2010);
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69-830-DJ, 63-385-DJ, 63-386-DJ, and 63-266-DJ (expire 03/2011); and
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64-453-DJ (expires 04/2011).
The particulate matter is composed of subvisible inert stainless steel particles measuring approximately 2.5 µm. When present in low numbers as observed, particles of this size are not known to constitute a health hazard. Experimental animal and human data indicate that they are scavenged by macrophages and other cells of the reticuloendothelial system without adverse effects. Although aggregates have not been observed, if the subvisible particles were to aggregate, or if larger particles were present, then they could become visible and could theoretically reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions.
For medical inquiries, adverse event reporting, or quality issues related to Cleviprex, providers are being asked to contact The Medicines Company by telephone at 1-888-977-6326 or by email at .
圣路易斯(MD Consult)——2009年12月16日，Medicines公司和美国食品药品管理局(FDA)宣布主动召回11批Cleviprex (丁酸氯维地平)静脉注射用乳剂。召回的原因为在一次常规年检中某些药瓶中发现可见的微粒物质。Medicines公司尚未收到任何有关此问题的产品投诉或不良事件报告。
Cleviprex可用作急性期高血压患者口服药治疗不可行或不适宜时的降压治疗药。
受累的Cleviprex批次如下：
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61-978-DW、61-979-DW和 61-980-DW (有效期至2010年1月)；
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68-404-DJ、68-405-DJ和 68-406-DJ (有效期至2010年8月)；
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69-830-DJ、 63-385-DJ、63-386-DJ和 63-266-DJ (有效期至2011年3月)；以及
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64-453-DJ (有效期至2011年4月)。
此微粒物质由显微镜下可见的惰性不锈钢微粒(直径接近2.5 µm)构成。尚不知该直径的微粒在为数不多时是否会威胁健康。动物实验及人类试验的数据显示，这些微粒可为巨噬细胞及网状内皮系统的其他细胞所清除，无不良影响。尽管尚未观察到聚合物，但若这些显微镜下可见的微粒发生聚集，或若出现较大微粒，进而演变成肉眼可见物，那么理论上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，或引发急性或慢性炎性反应。
若有与Cleviprex有关的药物咨询、不良事件报告或质量问题，请联系Medicines公司，可致电1-888-977-6326或发电子邮件至。
