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?