It Has Been Far From Smooth Sailing For Pradaxa During The Two Years It Has Been Available In The United States
(Posted by Tom Lamb at DrugInjuryWatch.com)
As we reported in this earlier article, "Pradaxa Safety Debate Continues During November 2012 With Many Different Conclusions And Positions", there was a flurry of activity in early November 2012 on the issue of whether Pradaxa (dabigatran) is an unsafe drug or a great improvement over Coumadin (warfarin).
In the first part of December 2012 Boehringer Ingelheim Pharmaceuticals, Inc., the drug company responsible for Pradaxa, seems to be trying to assure doctors and patients that its relatively new, and certainly controversial, blood thinner medication is safe.
As background, from the time when FDA approved Pradaxa in October 2010 through August 2012, approximately 3.7 million prescriptions for Pradaxa were dispensed, and approximately 725,000 patients received a dispensed prescription for Pradaxa from U.S. outpatient retail pharmacies during that period.
The recommended dose of Pradaxa is 150 mg given orally twice daily for patients with a creatinine clearance (CrCl) of more than 30 mL/minute. For patients with severe renal impairment and a CrCl of 15 to 30 mL/minute, the recommended dose of Pradaxa is 75 mg orally twice daily. We point out that Pradaxa dosing recommendations cannot be provided for patients with a CrCl of less than 15 mL/minute or to patients receiving dialysis.
Perhaps in an attempt to bolster the safety profile of Pradaxa and/or increase those sales numbers, Boehringer Ingelheim recently issued this December 8, 2012 press release: "New Sub-Analyses Report Pradaxa® (dabigatran etexilate mesylate) May Be Associated With Better Patient Outcomes After a Major Bleeding Event Compared to Warfarin". This new drug company article summarizes data from two retrospective sub-analyses concerning patients treated with Pradaxa or warfarin that was presented at the 54th Annual Meeting of the American Society of Hematology (ASH).
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From the December 8, 2012 Pradaxa press release:
Boehringer Ingelheim Pharmaceuticals, Inc. today announced results from two new post-hoc sub-analyses comparing the clinical management and outcomes of patients who experienced major bleeding while treated with [Pradaxa (dabigatran)] or warfarin. These findings from the RE-LY® trial and four other Phase III trials report outcomes after a major bleed on [Pradaxa (dabigatran)], despite the lack of a specific reversal agent, may be better than after a warfarin-associated bleed. The sub-analyses also indicate that the overall medical resources used to manage bleeding were not greater with [Pradaxa (dabigatran)]....
“Bleeding, especially major bleeding, is a well-recognized concern with all blood thinners. The sub-analyses report that major bleeding outcomes with [Pradaxa (dabigatran)], using standard clinical support measures, appeared to be better than warfarin and required no greater use of medical resources,” said Sam Schulman, M.D., Ph.D., FRCPC(C), professor, Department of Medicine, McMaster University, Ontario, Canada....
Management of bleeding events for [Pradaxa (dabigatran)] or warfarin was based on current standards of clinical care, including: blood transfusion, fresh frozen plasma, vitamin K, prothrombin complex concentrate and recombinant factor VIIa. In the RE-LY sub-analysis alone, patients on [Pradaxa (dabigatran)] were more frequently treated with blood transfusions than those on warfarin (59.2 percent and 49.9 percent, respectively). Patients on [Pradaxa (dabigatran)] were less frequently treated with fresh frozen plasma than those on warfarin (19.8 percent and 30.2 percent, respectively).
We will watch to see if Boehringer Ingelheim issues any additional press releases based on the several Pradaxa data presentations that were made in Oral Sessions and Poster Sessions at the American Society of Hematology (ASH) Annual Meeting and Exposition in Atlanta, Georgia, from December 8 to 11, 2012.
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