Tag Archives: DABIGATRAN EXTILATE

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.

 

A PRADAXA CASES VIDEO – WHY NOW?

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PRADAXA (DABIGATRAN EXTILATE) was approved for use in the United States in October of 2010. In a relatively short period of time it has gained the attention, both negative and positive, of public health authorities in the United States, Canada, Europe, Japan, Australia & New Zealand, because of a significant number of fatalities associated with bleeding events. As of this time, April 2012, an accurate count is not available. However, as of November 2011 the anti-coagulant had been associated with over 260 deaths worldwide. Published reports estimate over 100 deaths in the United States from the time it was approved in October 2010 through the 1st Quarter of 2011. These statistics prompted the FDA to issue a safety communication and announce that it was conducting post marketing surveillance of PRADAXA bleeding events and adverse event reports.

In January 2012, new warnings or revised warnings were approved for use in the U.S. in conjunction with prescriptions of PRADAXA (DABIGATRAN EXTILATE). These new and revised warnings only add to questions about why the warnings were not stronger at the time the product was approved and what was known by the manufacturer, BOEHRINGER INGELHEIM, in conjunction with modifications and use in patients with compromised kidney functioning. We will elaborate and discuss the “new” warnings in a separate post on this site.

FREE CASE EVALUATIONS are available from the sponsor of this site.

PRADAXA: Dosing in USA is 75 mg or 150 mg only as of April 2012.

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.

 

 

PRADAXA CASES OF DEATH REPORTED

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PRADAXA® CASES_LAWSUITS_BLEEDS

PRADAXA® CASES OF DEATH REPORTED AS 260 IN NOVEMBER 2011.

PRADAXA LINKED TO 260 DEATHS WORLDWIDE AS OF NOVEMBER 2011
PRADAXA cases involving deaths were reported in November of 2011 as totaling 260 “reported” PRADAXA CASES.  As a result, PRADAXA LAWSUIT investigations have been initiated.  It is anticipated that PRADAXA LAWSUITS will be filed throughout 2012 as a result of PRADAXA CASES where patients have bled irreversibly and uncontrollably leading to their deaths.

REUTERS reported on the potential “safety signal” and rise in PRADAXA CASES in a story published on November 12, 2011, entitled “BOEHRINGER SAYS ABOUT 260 DEATHS RELATED TO PRADAXA“. The REUTERS report notes that this was allegedly “still below the rate that emerged in the clinical trials that led to the drug’s approval”. However, REUTERS also reported that the company had previously “said that 50 reported deaths were a reasonable order of magnitude”. Whether there are in fact more PRADAXA CASES involving deaths or disability is open to question given that as of November 2011 it appeared the company had grossly underestimated the global number of potential deaths.

PRADAXA CASES are being investigated by the sponsor of this site, Gabriel F. Zambrano, P.A..  FREE CASE EVALUATIONS of potential PRADAXA CASES are available upon request through the use of the form below.

Pradaxa® CASES LAWSUITS BLEEDS BLEEDING