Tag Archives: MedWatch

DEATHS LINKED TO PRADAXA CLIMB TO 542 – MAY 2012 UPDATE

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DEATHS LINKED TO PRADAXA CLIMB TO 542 IN U.S.

ISMP CONFIRMS 542 DEATHS LINKED TO PRADAXA WITH MORE ADVERSE EVENTS REPORTED IN 2011.

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.

IS PRADAXA "PROGRESS" AS ADVERTISED OR NOT?

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.

 

PRADAXA SAFETY UPDATE & ALERT – QuarterWatch

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FDA MedWatch Analysis of PRADAXA CASES by QuarterWatch.

QuarterWatch, Monitoring FDA MedWatch Reports, is published by the Institute for Safe Medication Practices. QuarterWatch is a trademarked and independent publication that monitors all domestic, serious adverse drug events reported to the U.S. Food & Drug Administration (“FDA”). An Executive Summary, dated January 12, 2012, examined available data from the FDA, Adverse Reporting System, (AERS), and related MedWatch reports for signals and findings regarding PRADAXA (DABIGATRAN EXTILATE). QuarterWatch noted 500 reports of fatal, disabling or other severe hemorrhages or PRADAXA CASES. QuarterWatch defines the term “signal” as evidence of sufficient weight to justify an alert to the public and scientific community, warranting further investigation. It also reported the manufacturer was continuing to work with the FDA to provider “better guidance to physicians about treating the oldest patients”. Their analysis suggested that elderly patients were at risk for severe bleeds resulting in harm not benefit to this undefined population. The authors of QuarterWatch suggested that review of PRADAXA (DABIGATRAN EXTILATE) and adverse effects on high risk patients need to be a national priority.

Notably, QuarterWatch also questioned a potential relationship between PRADAXA CASES, dosing and the age of patients. Another trend suggests that while prescriptions surged so did reports of serious adverse drug events. As a result, in the 1st Quarter of 2011, QuarterWatch, summarized findings as revealing data that justified their concerns.

The sponsor of this site, Gabriel F. Zambrano, P.A., is investigating PRADAXA CASES that include deaths, permanent disability, hospitalization, gastrointestinal hemorrhaging, hemorrhagic stroke and heart attacks. FREE CASE EVALUATIONS are available through use of the contact form below.

PRADAXA CASES & BLEEDING SYMPTOMS/SIDE EFFECTS.