FDA禁止机械心脏瓣膜患者使用达比加群

圣路易斯(MD Consult)——2012年12月19日，美国食品药品管理局(FDA)发布了一则接受机械人工心脏瓣膜植入术以预防主要血栓形成事件的患者使用抗凝血药Pradaxa(达比加群酯)的警告。欧洲一项临床试验最近被终止，原因是与使用华法林相比，使用Pradaxa的机械心脏瓣膜患者更多出现卒中、心梗和血栓形成，Pradaxa使用者瓣膜手术术后出血比例也高于华法林使用者。

FDA目前正在要求Pradaxa制造商在该药物说明书禁忌证中加入机械心脏瓣膜患者。Pradaxa没有被批准用于心脏瓣膜问题导致房颤的患者。医务专业人员应立即对正在服用Pradaxa的所有机械心脏瓣膜患者更换其他药物。

目前尚未对人造生物瓣膜患者使用Pradaxa的情况进行评价，因此无法对该类患者提出推荐意见。

Pradaxa已被批准用于减少非瓣膜房颤患者卒中和全身性栓塞风险。

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ST LOUIS (MD Consult) - On December 19, 2012, the US Food and Drug Administration (FDA) issued a warning about use of the anticoagulant Pradaxa (dabigatran etexilate mesylate) in patients with mechanical prosthetic heart valves as a means of preventing major thromboembolic events. A clinical trial in Europe was recently stopped because Pradaxa users were more likely to experience stroke, myocardial infarction, and blood clot formation on mechanical heart valves than were users of warfarin. Pradaxa users also experienced more bleeding after valve surgery than warfarin users.

The FDA is now requiring Pradaxa's manufacturer to include a contraindication in the drug's label for use of the drug in patients with mechanical heart valves. Pradaxa is not approved for patients with atrial fibrillation caused by heart valve problems. Health care professionals should promptly transition any patient with a mechanical heart valve who is taking Pradaxa to another medication.

The use of Pradaxa in patients with bioprosthetic valves has not been evaluated and cannot be recommended.

Pradaxa is approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.