Adverse Events of Xarelto now Outnumber Pradaxa’s

Blood thinner, Xarelto, has surpassed its rival, Pradaxa, in both the number of prescriptions written and the number of severe adverse events reported by its users, according to the findings of a new analysis.

In the latest issue of the Institute of Safe Medication Practices (ISMP) Report, which reviews and analyzes adverse event data submitted to the U.S. Food and Drug Administration (FDA), the number of complaints submitted involving Xarelto has surpassed Pradaxa, which once generated more adverse events involving severe or fatal health problems than any other drug monitored by the group.

As doctors switch from Pradaxa due to the serious adverse side effects reported, sales of Xarelto have increased and Pradaxa’s sales fell. However, doctors are now discovering that Xarelto may be just as dangerous.

According to the ISMP, there were 680 serious adverse events reports linked to Xarelto, compared to only 528 for Pradaxa just this last year. The reports involving Xarelto problems are increasing, while reported Pradaxa side effects are declining, researchers found.

Both Pradaxa and Xarelto are part of a new family of anticoagulants known as direct factor Xa inhibitors. The blood thinners have been promoted as superior alternatives to warfarin, which is commonly known by the brand name Coumadin, for prevention of strokes among patients with atrial fibrillation.

While warfarin has been the most popular anticoagulant for many decades, it is also known to be a risky drug that can cause bleeding problems, requiring careful monitoring during treatment to maintain the appropriate dose. Xarelto and Pradaxa are promoted as easier to use, but lack an approved reversal agent that can be administered to stop excessive bleeding problems.

When a user of warfarin experiences a hemorrhage of severe bleed, doctors are able to counteract the blood thinning effects of the medication with a dose of vitamin K. However, there are currently no FDA-approved reversal agents for Xarelto or Pradaxa, leaving doctors unable to control bleeding in many cases. This has resulted in a significant increase in the number of adverse events involving severe hemorrhages and deaths associated with the medications.

There have been thousands of reports of injuries and hundreds of deaths associated with Pradaxa use since it was introduced in October 2010. The FDA received at least 3,781 reports involving serious injuries associated with the use of Pradaxa during 2011, including 2,367 reports of hemorrhage and 542 deaths.

With Johnson & Johnson and Bayer’s Xarelto, however, some doctors have recently found off-label treatments to stop the bleeding, though there is no official reversal agent. Pradaxa manufacturer, Boehringer Ingelheim, claims it is on the verge of developing a reversal agent that would make their drug much safer. However, there are other safety measures that could make Pradaxa even safer, according to the ISMP.

“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,” the ISMP report 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 urged the FDA to recommend these options to doctors prescribing Pradaxa, according to the report.

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.

Since August 2012, the federal Pradaxa litigation has been consolidated as part of a multidistrict litigation (MDL), which is centralized before U.S. District Judge David R. Herndon in the Southern District of Illinois to reduce duplicative discovery, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts. The company also faces Pradaxa lawsuits in state courts in Illinois, California and Connecticut.

As part of the coordinated management of the cases in the federal court system, Judge Herndon has scheduled a series of early trial dates in the Pradaxa MDL, known as bellwether cases. These trials were set to begin between August 2014 and February 2015, with the outcomes designed to help the parties gauge how juries are likely to respond to certain evidence and testimony that may be repeated throughout a large number of cases. However, Judge Herndon pushed back the trial dates about 30 days and established a new order for the cases to go before the juries. The first case is expected to begin September 15, 2014 and the last bellwether case scheduled to begin March 23, 2015.

Following the bellwether trials, if the parties do not make progress toward reaching Pradaxa settlement agreements, it is possible that Judge Herndon will begin remanding hundreds of cases back to U.S. District Courts where they were originally filed for separate trial dates.

For more information, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).

Related Posts