PRADAXA (DABIGATRAN) DEATHS EXCEED 542 IN UNITED STATES
PRADAXA was celebrated as a new and relatively care free replacement to WARFARIN or COUMADIN. Granted, patients in need of anti-coagulant therapy had some pre-existing need for a blood thinner. However, since having been approved in October 2010, PRADAXA has been linked to at least 542 deaths in the United States.
On May 31, 2012, the Institute for Safe Medication Practices (ISMP), which works with the U.S. Food & Drug Administration (FDA) evaluating adverse event reports associated with popular drugs, released their “QuarterWatch, Monitoring FDA MedWatch Reports” analyzing New Data from the 3rd and 4th Quarters of 2011. Prior reports noted “safety signals” associated with the launch and rapid adoption of PRADAXA as an anti-coagulant therapy. Their latest analysis continues to raise concerns and red flags over the number of events linked to use of PRADAXA (DABIGATRAN) and dosing. Specifically, ISMP’s found the following from analyzing adverse event reports provided to the FDA:
- PRADAXA was associated with 3,781 serious adverse event reports.
- PRADAXA outpaced all regularly monitored drugs in reports of hemorrhage with 2,367 cases reported.
- PRADAXA was linked to 644 cases of strokes.
- PRADAXA was linked to 542 patient deaths.
- PRADAXA was linked to 291 cases of acute renal failure.
- PRADAXA was suspected in 15 cases of liver failure.
In contrast, WARFARIN or COUMADIN was linked to 1,106 cases overall and only 72 deaths. Comparisons are inevitable, and necessary given that PRADAXA (DABIGATRAN) has been heavily marketed as a superior alternative to WARFARIN and COUMADIN despite their long standing history of clinical use and study. Overall adverse events associated with PRADAXA (DABIGATRAN) outnumbered WARFARIN or COUMADIN threefold.
Public health authorities in Europe, Japan, Australia and New Zealand began to raise questions about the number of adverse events during November of 2011. ISMP’s report appears to confirm cause for alarm and scrutiny as civil litigation has now been initiated in the United States on behalf of patients, or their surviving family members, following adverse events linked to use of PRADAXA (DABIGATRAN).
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