FDA safety review of Pradaxa continues

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According to a press release on November 2, 2012, the Food and Drug Administration (FDA) is continuing to review data regarding the safety of the pharmaceutical anticoagulant Pradaxa.  Using insurance claims and administrative data, the FDA determined that the bleeding risks associated with new Pradaxa use did not appear to be greater than the bleeding risks associated with new use of warfarin.  The FDA has not changed its recommendations regarding Pradaxa.

However, the FDA has not addressed the issue of the lack of antidote for Pradaxa bleeds. In contrast to other anticoagulant pharmaceuticals such as warfarin (Coumadin, Jantoven, and generics), bleeding associated with Pradaxa cannot be counteracted by the administration of Vitamin K.  Healthcare professionals are urged to carefully follow the dosing recommendations for Pradaxa, especially for patients with renal impairment.

For more information, contact the Ohio Pradaxa lawyers at Clark, Perdue & List. 

Source: Food and Drug Administration MedWatch, “Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication – Safety Review of Post-Market Reports of Serious Bleeding Events,” November 2, 2012.