Pradaxa Benefit Outweighs Bleeding Risk, FDA Says

Dec. 7, 2011— -- The FDA has announced today that patients taking the anticoagulant Pradaxa to reduce the risk of stroke associated with atrial fibrillation should continue to take the drug as directed, despite post-market reports of severe bleeding.

A report of about 50 cases of fatal bleeding worldwide associated with the drug surfaced in November.

Drugmaker Boehringer Ingelheim said at the time that dabigatran's safety profile was in line with that seen during the RE-LY clinical trial, which compared dabigatran with warfarin in more than 18,000 participants.

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And the FDA noted in Wednesday's announcement that dabigatran's label contains a warning about significant and sometimes fatal bleeds, and noted that in the randomized RE-LY trial, both arms had similar major bleeding rates.

Although the agency is continuing to monitor the situation, at this time it "believes that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label."

In its statement the agency said that patients should not stop taking the drug without consulting a physician because doing so could increase the risk of stroke.

In the meantime, physicians and healthcare professionals should report any adverse events or side effects associated with dabigatran to FDA's MedWatch Safety Information and Adverse Event Reporting Program.