Xarelto Dangers rival Pradaxa

Xarelto dangers rival those of Pradaxa,Xarelto_Bottle_LR according to an Institute of Safe Medication Practices (ISMP) Report (PDF). Xarelto has even surpassed rival blood thinner Pradaxa for prescriptions written and for its number of severe adverse events reported by users.

ISMP Analysis

After reviewing and analyzing the FDA’s adverse event data, the ISMP states that the number of complaints submitted involving Xarelto surpassed Pradaxa last year. At one point, Xarelto generated more adverse event reports involving severe or fatal health problems than any other drug monitored.

ISMP reports that 680 serious adverse events linked to Xarelto were reported in the last year,  compared with 528 for Pradaxa.

The report speculates that rising sales of Xarelto and falling sales of Pradaxa are probably behind the shift. Many doctors have apparently switched from Pradaxa to Xarelto because of adverse events attributed to Pradaxa.

New Drugs, Deadly Problems

Pradaxa and Xarelto are both blood thinners that are part of a new family of anticoagulants known as direct factor Xa inhibitors. They have both been promoted as superior alternatives to warfarin – commonly known by the brand name Coumadin – to prevent strokes in patients suffering from atrial fibrillation.

While warfarin has been the “gold standard” anticoagulant for decades, it can also cause bleeding problems that require careful monitoring. Xarelto and Pradaxa have both been promoted as easier to use and monitor when compared with warfarin, but both Xarelto and Pradaxa lack an approved agent to stop the bleeding problems that they can trigger.

Vitamin K Anecdote vs. No Anecdote

While doctors can effectively administer vitamin K when a warfarin user suffers a hemorrhage or severe bleed, no FDA-approved reversal agent exists for Xarelto or Pradaxa, which means victims can bleed out and die.

With Xarelto, some doctors have recently found off-label treatments to stop the bleeding, but there is still no official reversal agent. Pradaxa’s maker, Boehringer Ingelheim, meanwhile, claims to be on the verge of developing a reversal agent that would make Pradaxa safer. According to the ISMP, there are other safety measures that could make Pradaxa safer.

The ISMP report states: “Newly published data also show that the bleeding risks of [Pradaxa] could be substantially reduced if two therapeutic options available in most advanced countries were approved in the United States. Those options are a lower, 110 mg twice daily (BID) dose, and a laboratory test capable of identifying patients who need a dose adjustment because the effect on thrombin inhibition is either excessive, increasing the risk of severe bleeding, or sub-therapeutic, exposing the patient to a higher risk of stroke or other blood-clot related adverse event.”

ISMP has asked FDA to recommend these options to doctors who prescribe Pradaxa.

The German newspaper Der Speigel (in German) indicates that at least 968 adverse events involving Xarelto were reported to German health officials in the first eight months of 2013, including 72 deaths.

The numbers compare to 750 adverse event reports and 58 deaths throughout all of last year, indicating that the the increase tracks with the rise in use of Xarelto, which has reportedly increased 240% after just a year and a half on the market.

– See more at: http://www.aboutlawsuits.com/xarelto-side-effects-problems-deaths-53000/#sthash.aKb615C1.dpuf

The German newspaper Der Speigel (in German) indicates that at least 968 adverse events involving Xarelto were reported to German health officials in the first eight months of 2013, including 72 deaths.

The numbers compare to 750 adverse event reports and 58 deaths throughout all of last year, indicating that the the increase tracks with the rise in use of Xarelto, which has reportedly increased 240% after just a year and a half on the market.

– See more at: http://www.aboutlawsuits.com/xarelto-side-effects-problems-deaths-53000/#sthash.aKb615C1.dpuf

Xarelto and Pradaxa Lawsuits

Boehringer Ingelheim currently faces more than 2,000 Pradaxa lawsuits filed by individuals who allege that the drug maker failed to warn the medical community that there was no reversal agent.

Federal Pradaxa litigation was consolidated in August 2012 as part of a Multidistrict Litigation (MDL) centralized before U.S. District Judge David R. Herndon in the Southern District of Illinois. An MDL is formed in such cases to reduce the duplication of discovery, avoid conflicting rulings from different judges, give a measure of convenience for the parties, witnesses and the courts. Other Pradaxa lawsuits have been filed against Boehringer Ingelheim in state courts in Illinois, California and Connecticut.

Judge Herndon has thus far scheduled a series of trial dates in the Pradaxa MDL known as bellwether cases. These trials are scheduled to begin between August 2014 and February 2015.

In February, the first Xarelto lawsuit was filed against Johnson & Johnson and Bayer in the Philadelphia County Court of Common Pleas. Allegations raised were very similar to those raised against Johnson & Johnson and Bayer in their making of Pradaxa.

Contact a Lawyer for a Xarelto Lawsuit

Matthews & Associates is prosecuting Pradaxa and Xarelto cases across the country in both state and federal courts. If you or someone you love was injured by Pradaxa or Xarelto, contact an experienced pharmaceutical lawyer today for a free consultation.

Xarelto Dangers rival Pradaxa (return)

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