DABIGATRAN IS PRADAXA, A BLOOD THINNER RECENTLY THE SUBJECT
OF LAWSUITS AND INVESTIGATIONS OVER ADVERSE EVENTS SINCE 2010.
PRADAXA is a trademarked anti-coagulant or blood thinner that is manufactured by BOEHRINGER INGELHEIM. The drug contains DABIGATRAN ETEXILATE (hereinafter “DABIGATRAN“) and has been celebrated as a new treatment for patients suffering from AFib or Atrial Fibrilation. AFib is a condition where the upper chambers of the heart beat out of sync and can lead to potentially fatal blood clots. DABIGATRAN is approved for other uses outside of the United States. However, the U.S. Food & Drug Administration has only approved the use of DABIGATRAN for nonvalvular AFib in the U.S., and other use in the U.S. is not FDA approved and known as “off-label”.
DABIGATRAN, as PRADAXA, has only been in use since October 2010. However, it has been linked to an extraordinary number of “adverse events”, including deaths. As of November 2011, DABIGATRAN had been linked to over 260 deaths worldwide and had become the growing subject of scrutiny by public health authorities. In the U.S., use of the drug had generated hundreds of adverse event reports including:
- 120 Deaths
- 25 Cases of Permanent Disability
- 543 Cases Requiring Hospitalization
The above were reported by the ISMP Medication Safety Alert, QUARTERWATCH (First Quarter 2011) Signals for Dabigatran. ISMP publishes QUARTERWATCH in an effort to improve patient safety by identifying “signals” that may represent important drug safety issues. ISMP defines “signal” as evidence they judge to be substantial enough to warrant publication and which may require further investigation.
ISMP identified 932 DABIGATRAN related events, through an analysis of FDA records, and 505 of those involved hemorrhage. The data, according to ISMP exceeded, reports of hemorrhage for WARFARIN or COUMADIN, the very anti-coagulant that DABIGATRAN and PRADAXA were designed to replace or compete against.
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