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FDA Safety Announcement for Pradaxa Ignores Lack of Reversal Agent

3 comments

On Friday, the FDA released an updated Drug Safety Communication regarding the anticoagulant Pradaxa, manufactured by Boehringer Ingelheim. According to the Communication, the FDA has examined insurance claims and administrative data to compare bleeding rates between Pradaxa and warfarin (known mostly by the brand name Coumadin). The FDA reports that bleeding rates do not appear to be higher with Pradaxa therapy than with warfarin therapy. The FDA reports that these findings are consistent with the RE-LY trial, which was a large clinical trial that served as the basis for the approval of Pradaxa.

On the same day that the FDA released its updated Drug Safety Communication, the New York Times published an article calling Pradaxa a "promising drug with a flaw." The article recounts the short history of Pradaxa, and mentions the fact that, though the drug has generated more than a billion dollars in revenue, it has been linked to more than 500 deaths in the two years it has been on the market. The article also points out that, while the incidence of bleeding may be no higher for patients on Pradaxa, the FDA has not addressed the lack of a reversal agent for Pradaxa. Because there is no reversal agent, physicians may have great difficulty reversing a bleed that occurs in a patient on Pradaxa.

More than 100 lawsuits have been filed across the country by patients claiming they were injured by taking Pradaxa. The vast majority of those claim injuries related to bleeds that could not be reversed easily.

As the FDA points out in its Communication, it is continuing to evaluate data and review Pradaxa. We encourage continued review and close scrutiny of the data. If the bleeding data is the same, why would a well-controlled patient need to be moved from warfarin to Pradaxa?

3 Comments

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  1. Steve K says:
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    Key thing to remember is that Pradaxa significantly reduces the risk of stroke. To be exact it’s a 35% relative risk reduction. Do you not see that as a benefit?

  2. Chuck,MD says:
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    Well, maybe if you were a physician instead of a lawyer you would understand the answer to your question: “…why would a well controlled patient need to be moved from warfarin to pradaxa”. The answer is simple: easier monitoring and administration and more predictable dose/drug level relationship. Pradaxa has never claimed to be a drug with lower bleeding risk. Common sense dictates that any anti-coagulant or “blood thinner” increases bleeding risk. With that said, I do agree that the lack of an antidote is concerning and I do think that is the one reason to consider using warfarn, despite it’s own flaws, over pradaxa.

  3. Steven Davis says:
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    Sorry for the delay in responding to these comments. The holidays and my day job got in the way.

    Steve K – The 35% relative risk reduction is an absolute risk reduction of less than 1%, and the greatest reduction was in patients not adequately thinned by warfarin. While any absolute risk reduction is a benefit, a reduction of less than 1% very small, and does not appear to outweigh the risks of Pradaxa.

    Chuck, MD – Easier isn’t always better. How can a phyician know if a patient on Pradaxa is properly anticoagulated? Pradaxa was approved based on one study, and it was less than the gold standard. What if, instead of simply “never claiming to be a drug with a lower bleeding risk”, the bleeding risk is actually greater on Pradaxa than on warfarin? Data from the single trial indicates that the bleedeing risk is greater on Pradaxa than on warfarin among patients whose INR is well-controlled by warfarin. Would a patient whose blood is adequately thinned by warfarin risk switching to Pradaxa just to avoid the tests if it is clear that there is no reversal agent and that the risk of bleeding is greater on Pradaxa? I’m sure some would, but I suspect most would not. In any event, the company must tell the truth about its product.