December 7th, 2011

FDA Undertakes Safety Review of Dabigatran (Pradaxa)

The FDA announced today that it is initiating a safety review of dabigatran (Pradaxa, Boehringer Ingelheim). The review was prompted by reports of serious bleeding events in people taking the drug.

Bleeding complications, the FDA acknowledges, are a “a well-recognized complication of all anticoagulant therapies.” The agency says it is “working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected.”

The FDA notes that it is difficult to compare bleeding complications between dabigatran and warfarin, since complications associated with the older warfarin may be less likely to provoke an adverse event report.

2 Responses to “FDA Undertakes Safety Review of Dabigatran (Pradaxa)”

  1. VAZHA AGLADZE, MD., PhD says:

    As I remember, Dabigatran’s one of the best advantage was, that it doesn’t require INR frequent monitoring…or any monitoring at all…

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  2. Douglas Sheena, MD says:

    Unfortunately, it is both an advantage, and a disadvantage. On the plus side, patients can avoid monthly (or more frequent) blood tests to evaluate their anticoagulation status.

    On the minus side, there is no practical way to determine if the patient is overanticoagulated until they start bleeding.

    Also on the minus side, if the bleeding is life-threatening (e.g., intracranial hemorrhage), no one is really sure how to treat it.

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