Tag Archives: dabigatran etexilato

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.

 

AFFIRMED APRIL 2012: SAFETY SIGNALS & RED FLAGS

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On April 5, 2012, ISMP (“INSTITUTE FOR SAFE MEDICATION PRACTICES”) released their trademarked QuarterWatch and updated information relating to PRADAXA (DABIGATRAN EXTILATE). ISMP’s latest analysis affirmed their prior analysis and concerns over the potential for overdosing of the anti-coagulant leading to cases reported to the U.S. Food & Drug Administration (“FDA”). Their analysis begs the question: Is PRADAXA PROGRESS as advertised ?

IS PRADAXA "PROGRESS" AS ADVERTISED OR NOT?

ISMP’s data revealed that DABIGATRAN was the suspect in 856 reported cases of adverse events in FDA’s MedWatch Adverse Event Reports (AERS). ISMP and FDA recently announced their joint partnership in preventing medication errors and information sharing lending even more support to ISMP’s ability to identify problems and red flags. ISMP analyzed data for the 2nd Quarter of 2011, which includes a snapshot of information following the October 2010 approval and introduction of PRADAXA in the United States. ISMP’s analysis included a “new quarterly total” of 117 reported patient deaths. This is a noteworthy statistic because reports are voluntary and some patient deaths may not have been associated with PRADAXA at the time as widespread reports of international deaths and case reports did not emerge until November 2011 and March 2012 respectively. PRADAXA CASES identified by ISMP include 511 reported cases of hemorrhage, thus reinforcing their concerns that older patients may be overdosing on the new anti-coagulant.

ISMP PRADAXA UPDATE - APRIL 2012.

Again, adverse events may be underreported because there is an expectation that bleeding, or hemorrhage, is associated with anti-coagulant treatments. This may lead to underreporting. This theme will be explored through the initiation of PRADAXA CASES in civil court lawsuits involving fatalities, disabling and serious injuries. ISMP’s data identifies PRADAXA as being associated with more adverse events than any other monitored drug. Can the manufacturer, BOEHRINGER INGELHEIM, claim this does not raise a litany of red flags ? In December 2012, FDA articulated calls for post-marketing surveillance of the new anti-coagulant. This was followed by January 2012 label changes discussed here. Sadly, the eager acceptance and use of PRADAXA between October 2010 and January 2012 may have exposed a patient population to higher risks and adverse events that were arguably avoidable.

CASE EVALUATIONS are available here through the sponsor of this site.

 

ADVERTENCIA: PRADAXA SANGRADO 2012

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ADVERTENCIA: PRADAXA SANGRADO 2012

La experiencia clinica en pacientes de edad avanzada (mas de 75 anos de edad) y PRADAXA (DABIGATRAN ETEXILATO) es limitada. Tratamiento con PRADAXA en pacientes con insuficiencia renal grave esta contraindicado. PRADAXA puede producir episodios de sangrado mayor or grave. Es posible que pueden producir discapacidad, ser potentcialmente mortales o incluso producir la muerte.