DEATHS LINKED TO PRADAXA CLIMB TO 542 IN U.S.
PRADAXA (DABIGATRAN ETEXILATE) remains under close watch by prescribers that know, or have seen, “safety signals” and red-flags associated with use of the drug. A recently released report from the Institute for Safe Medication Practices (ISMP): QuarterWatch, Monitoring FDA MedWatch Reports, Anticoagulants the Leading Reported Drug Risk in 2011, May 31, 2012, evaluates new data from 2011 for the 3rd and 4th Quarters. The reports opens by noting that “the most frequently identified suspect drugs in direct reports to the FDA were the anticoagulants dabigatran (PRADAXA) and warfarin (COUMADIN)”. Ironically, PRADAXA has been marketed as a novel replacement for COUMADIN which has been in use for over 1/2 a century. Whether the results should simply raise more red flags or be interpreted as alarming is subject to interpretation. Regardless, here is the sum of ISMP’s findings and numbers. Please note that, these are “reported” and there is no way to account for yet to be reported, or never reported events:
- 817 where PRADAXA (DABIGATRAN) was the leading suspect in a direct report to the FDA in 2011.
- 3,781 domestic, serious adverse events overall in 2011 including both manufacturer and direct reports.
- 542 patient deaths.
- 2,367 reports of hemorrhage – outpacing all other regularly monitored drugs.
- 291 acute renal failure.
- 644 strokes.
- 15 cases where it was suspect in liver failure.
Comparisons to WARFARIN (COUMADIN) are inevitable as it has been the generic anti-coagulant of choice since 1954 and remains a mainstay in therapy. It accounted for 1,106 cases overall in 2011 and 72 deaths according to ISMP.
You have to openly wonder whether or not “PRADAXA is PROGRESS” as claimed in the aggressive direct to consumer marketing campaigns that bombarded the airwaves and remain available on line.
The numbers, whether underreported or not, speak for themselves. Sadly, they arguably reflect avoidable events, including deaths, with real people that experienced an injury and related issues. Unless, or until, victims come forward how many have really suffered an injury or event will not be known. Recent lawsuits and related litigation against the manufacturer may assist in helping related issues gain widespread recognition and the public health threat presented by this new anticoagulant.
We are actively investigating, and representing, survivors of deceased family members that used PRADAXA (DABIGATRAN) since October 2010. We are also evaluating and investigating cases involving serious personal injuries, or injuries resulting in disabilities from use of PRADAXA (DABIGATRAN). A FREE CASE EVALUATION is available through use of the contact form below.