FDA backs previous stance on Pradaxa bleeding risks

Federal health officials have issued an update on its stance on the new blood thinner drug Pradaxa, indicating the risk of severe bleeding associated with the drug is no more significant than any other drugs available on the market for the same purpose.

This stance goes against a lot of current research that found Pradaxa to carry a more significant risk of severe bleeding episodes – namely gastrointestinal and cerebral hemorrhaging – than drugs that had been available for years on the market, like Coumadin (warfarin). The Food and Drug Administration announced this finding after a review of insurance claims and a check of of its Mini-Sentinel pilot of the Sentinel Initiative, the agency announced in a Drug Safety alert recently. 

In that statement, the FDA notes, “he results of this assessment indicate that bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin, which is consistent with observations from the large clinical trial used to approve Pradaxa (the RE-LY trial).”

The FDA said this stance is no different than a previous one the agency took late last year on Pradaxa’s safety. The agency still acknowledges that Pradaxa users face a risk of severe bleeding but it is no more than that faced by patients on similar drugs used for that purpose. The FDA believes Pradaxa is safe however, when it is prescribed as directed.

In December of last year, the FDA echoed the findings of numerous clinical studies that associated Pradaxa with an increased risk of severe bleeding episodes, including fatal incidents of gastrointestinal and cerebral hemorrhaging. It is believed that Pradaxa has been the cause of more than 250 deaths during its short time on the market but it was not known whether that total was expected or if it was higher than company marketing the drug, Germany-based Boehringer Ingelheim, had envisioned during the drug’s initial phases on the market.

The FDA said in its most recent statement that the agency is continuing to investigate whether those bleeding episodes are happening more than expected.

Pradaxa, unlike its predecessors, does not have an antidote and patients suffering from atrial fibrillation who rely on the drug to thin blood to prevent clots that could lead to stroke, heart attack, or death, could be setting themselves up for an irreversible bleeding episode. Even the most minor cut or internal bleeding episode can spark an uncontrollable bleeding episode that can become life-threatening if it is not controlled. Since Pradaxa does not have an antidote, it is difficult for healthcare professionals to curb these bleeding episodes in many cases.

In its statement, the FDA found that it “continues to believe 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.”

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