8个批次1 mg吸塑包装的Coumadin被召回

ST LOUIS (MD Consult) - On July 12, 2010, Bristol-Myers Squibb (BMS) announced that it is conducting a voluntary recall of 3 lots of physician sample blister packs of Coumadin 1-mg tablets and 5 lots of Coumadin 1-mg tablet hospital unit dose blister packs that have been distributed in the United States. This recall does not involve Coumadin 1-mg tablets supplied in bottles, nor does it involve any other strengths and dosage forms of the product.

The lot numbers for the recalled products are the following: 9A48931A, 9A48931B, and 9A48931C for the sample packs; and 8F34006B, 8K44272A, 8K46168A, 9F44437A, and 9K58012B for the hospital packs. Expiration dates on the recalled products range from June 2011 to November 2012.

The manufacturer determined that some of a product (isopropanol) used in the tablets to maintain the active ingredient (coumadin) in a crystalline state may not meet certain specifications. Theoretically, this issue could create variance in therapeutic levels of the active ingredient in persons taking the drug. A decrease in the level of the active ingredient could increase the risk of thrombosis, which could lead to myocardial infarction or stroke. An increase in the level of the active ingredient could heighten the risk for hemorrhage.

To date, BMS has not received any reports of adverse events related to this issue.

Medical inquiries about the recall can be directed to BMS by telephoning 1-800-321-1335 (option 5). Any adverse reactions may be reported to the MedWatch Program of the US Food and Drug Administration.

圣路易斯(MD Consult)­——2010年7月12日，百时美施贵宝(BMS)公司宣布，该公司正在美国范围内开展对1 mg吸塑包装的Coumadin药片的召回工作，主动召回3个批次的医师用样品和5个批次的医院用药品。此次召回不包括1 mg Coumadin瓶装药及该药品的其他任何规格或剂型。

被召回的批号如下：9A48931A、9A48931B和 9A48931C(样本包装)；8F34006B、8K44272A、8K46168A、9F44437A以及9K58012B(医院用的包装)。被召回药品的有效期为2011年6月至2012年11月。

生产厂家确定，药片中维持有效成分(coumadin)保持结晶状态所使用的某种药品成分(异丙醇)可能未达到规定。理论上，这会使服药者体内有效成分的治疗水平产生差异。有效成分水平降低会增加血栓形成的风险，继而导致心肌梗死或卒中，而有效成分水平升高会增加出血风险。

迄今，BMS尚未收到任何与此问题有关的不良事件报告。

与召回有关的医学问题可直接通过致电1-800-321-1335(选择5)反馈至BMS。对任何不良反应均可直接上报至美国食品药品管理局(FDA)的MedWatch Program。