PRADAXA BLEEDING DEATHS EXCEED 542 IN US SINCE OCTOBER 2010

PRADAXA (DABIGATRAN) DEATHS EXCEED 542 IN UNITED STATES

PRADAXA DEATHS IN U.S. SINCE OCTOBER 2010 AT LEAST 542 PER ISMP.

PRADAXA was celebrated as a new and relatively care free replacement to WARFARIN or COUMADIN. Granted, patients in need of anti-coagulant therapy had some pre-existing need for a blood thinner. However, since having been approved in October 2010, PRADAXA has been linked to at least 542 deaths in the United States.

On May 31, 2012, the Institute for Safe Medication Practices (ISMP), which works with the U.S. Food & Drug Administration (FDA) evaluating adverse event reports associated with popular drugs, released their “QuarterWatch, Monitoring FDA MedWatch Reports” analyzing New Data from the 3rd and 4th Quarters of 2011. Prior reports noted “safety signals” associated with the launch and rapid adoption of PRADAXA as an anti-coagulant therapy. Their latest analysis continues to raise concerns and red flags over the number of events linked to use of PRADAXA (DABIGATRAN) and dosing. Specifically, ISMP’s found the following from analyzing adverse event reports provided to the FDA:

  • PRADAXA was associated with 3,781 serious adverse event reports.
  • PRADAXA outpaced all regularly monitored drugs in reports of hemorrhage with 2,367 cases reported.
  • PRADAXA was linked to 644 cases of strokes.
  • PRADAXA was linked to 542 patient deaths.
  • PRADAXA was linked to 291 cases of acute renal failure.
  • PRADAXA was suspected in 15 cases of liver failure.

In contrast, WARFARIN or COUMADIN was linked to 1,106 cases overall and only 72 deaths. Comparisons are inevitable, and necessary given that PRADAXA (DABIGATRAN) has been heavily marketed as a superior alternative to WARFARIN and COUMADIN despite their long standing history of clinical use and study. Overall adverse events associated with PRADAXA (DABIGATRAN) outnumbered WARFARIN or COUMADIN threefold.

Public health authorities in Europe, Japan, Australia and New Zealand began to raise questions about the number of adverse events during November of 2011. ISMP’s report appears to confirm cause for alarm and scrutiny as civil litigation has now been initiated in the United States on behalf of patients, or their surviving family members, following adverse events linked to use of PRADAXA (DABIGATRAN).

A FREE CASE EVALUATION is available through the use of the contact from below from the sponsor of this site. 


 

ANALYSIS OF PRADAXA BLEEDS, BLEEDING LEAD TO SAFETY ALERTS

PRADAXA BLEEDS & BLEEDING RAISE SAFETY ALERTS.

International reports of PRADAXA BLEEDS and fatalities emerged in November 2011. PRADAXA (DABIGATRAN EXTILATE) had only been approved for use in the U.S. since October 2010. With actual approval came prescriptions and a significant number of adverse reports and PRADAXA BLEEDS resulting in death. The reports have drawn calls for national concern in the U.S., following international action in Europe, Australia and Japan over uncontrolled bleeding and related events.

The U.S. Food & Drug Administration, (“FDA”) monitors potential safety issues on approved drugs through the Adverse Event Reporting System (“AERS”). PRADAXA (DABIGATRAN EXTILATE) was identified by FDA in “Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) Between July – October 2011“. At the time, FDA noted that the “Potential Signal of Serious Risk/New Safety Information” was “[b]leeding events including hemorrhage with fatal outcome“or PRADAXA BLEEDS. This information was as of October 31, 2011, subsequent communications by FDA are discussed here on PRADAXA BLEEDS.

What number of PRADAXA BLEEDS, involving deaths, or complications, were enough to raise red flags is unclear at the present. However, it appears with use of PRADAXA on the rise, reports of serious adverse events and complications also rose because of the lack of antidote or reversal agent. Additionally, it appears that a fine line exists between the risk versus benefit analysis required for new patients, or those crossing over from established blood thinners that have been available, and managed in clinical practice, for over 50 years.

FREE CASE EVALUATIONS are available from the sponsor of PRADAXA CASES, Gabriel F. Zambrano, P.A.. Gabriel F. Zambrano, P.A., is actively investigating PRADAXA CASES involving death, permanent disability, hospitalization, gastrointestinal hemorrhaging, hemorrhagic stroke and heart attacks.

PRADAXA® BLEEDS SYMPTOMS

PRADAXA®(dabigatran etexilate)- BLEEDS & 260 DEATHS REPORTED AS OF NOVEMBER 2011

Pradaxa®(dabigatran etexilate)

Pradaxa®(dabigatran etexilate) can potentially cause a PRADAXA BLEED from PRADAXA BLOOD.