Tag Archives: PRADAXA VS WARFARIN

PRADAXA LAWSUIT UPDATE JULY 2012

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 PRADAXA (DABIGATRAN ETEXILATE) LAWSUIT UPDATE

Legal cases against BOEHRINGER INGELHEIM, the manufacturer of PRADAXA (DABIGATRAN ETEXILATE) have begun to gain momentum in the United States. As a result, a petition to organize the litigation in a Multi-District Litigation (MDL) in the Federal court system was filed. Naturally, this lead to interested parties presenting arguments, before the Judicial Panel on Multi-District Litigation (JPML), requesting particular venues. Regardless of where the JPML directs the formation of an MDL, it is clear that PRADAXA BLEEDS and related cases will become the subject of litigation nationwide.

Following the publicization of international concerns in November 2011, as well as repeated reports from the ISMP (highlighted below), it is possible that sales of the anti-coagulant may be slowing as word spreads to providers, prescribers and patients of the dangers associated with the use of the novel anti-coagulant.

PRADAXA SALES CLIFF - LAWSUIT UPDATE JULY 2012.

PRADAXA SALES CLIFF - LAWSUIT UPDATE JULY 2012.

The graphic above, from DRUGS.com, appears to show a drop off in “units”. Whether this downward trend will continue through 2012 remains to be seen. If it is related to growing suspicions and concerns over the future of PRADAXA (DABIGATRAN ETEXILATE) is unclear. Based upon IMSP’s past evaluation of FDA data tying the anti-coagulant to adverse events this trend is not surprising.

FREE PRADAXA CASE EVALUATIONS  ARE AVAILABLE THROUGH THE USE OF THE CONTACT FORM BELOW FROM THE SPONSOR OF THIS SITE.

IS PRADAXA "PROGRESS" AS ADVERTISED OR NOT?

 

PRADAXA RED FLAGS CONCERN HEART DOCTORS

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PRADAXA DEATHS & BLEEDING RAISE RED FLAGS FOR HEART DOCTORS

REUTERS REPORTS ON PRADAXA DEATHS, BLEEDING & LAWSUITS CAUSING CONCERN TO PHYSICIAN PRESCRIBERS.

In a June 14, 2012, REUTERS, entitled: ”TOP HEART DOCTORS FRET OVER NEW BLOOD THINNERS“, Randsell Pierson reports on the serious concerns and trepidation being raised by medical providers and prescribers over “new” blood thinners. PRADAXA (DABIGATRAN) was the first “new generation” blood thinner marketed as a lifestyle change for users because it required little monitoring or dietary changes. However, it has proven to have life altering consequences when the effects of the blood thinner combine with a trauma, or underlying disease, which complicates the outcome drastically and can lead to death. A competitive, and potentially dangerous, problem surrounding PRADAXA (DABIGATRAN) and other new blood thinners is illustrated by the aggressive marketing competing pharmaceutical companies have created to promote their new branded products. Citing the ISMP (Institute for Safe Medication Practices) data discussed in our post below, REUTERS examines, in part, the origin of the problem and again highlights the fact that PRADAXA (DABIGATRAN) has no antidote or quick reversal agent.

While the article quotes physicians, the physicians do not address the fact that ISMP’s data has confirmed 542 deaths and PRADAXA (DABIGATRAN) tops the list of drugs linked to adverse event reports as discussed below. All drugs come with risks. However, you cannot agree to accept the risks, or consequences, if the manufacturer is not providing the warning or information to prescribers so they can in turn pass it on to patients. This is a subtle point to some, but it is at the heart of PRADAXA CASES and ongoing lawsuits. Dr. Richard Besdine, Director of the Center for Gerontology at Brown University, is quoted as stating “[i]f there’s an adverse event lurking in the closet for a new drug, it’s most likely to come out in patients that are old and frail and taking multiple medications. They’re the canary in the coal mine“. Would you want to volunteer to become the canary in the coal mine or advance warning of the potential consequences?

FREE CASE EVALUATIONS are available for patients that have suffered serious injuries, or bleeding events from the use of PRADAXA (DABIGATRAN) through use of the contact form below.

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.