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Xarelto study shows drug's side effects

Nearly 2,300 federal Xarelto lawsuits are situated before a single multidistrict litigation court in the Eastern District of Louisiana. About 500 more are grouped before a mass tort state court in Philadelphia. Those are not all of the lawsuits alleging that the use of the anticoagulant led to serious, and in some cases fatal, internal bleeding. Just when the scientific evidence against Xarelto is published mainly in plaintiffs' petitions this holiday season, a national professional journal reacquaints medical science with some of the very damning findings.

The December edition - the current edition - of the Journal of the American College of Cardiology re-introduced the ROCKET AF study, which seemingly "propelled," if you will pardon the symbolism, the Janssen Pharmaceutical drug's 2011 approval by the U.S. Food and Drug Administration.

The FDA since 2011 has approved Xarelto for the following purposes:

  • To reduce the risk of deep vein thrombosis, or DVT, and pulmonary embolism, or PE, that might occur following knee replacement or hip replacement surgery
  • To actually treat DVT and PE and to reduce their recurrence following initial treatment
  • To reduce the risk of stroke in people who have a type of abnormal heart rhythm called non-valvular atrial fibrillation

The ROCKET AF study, originally published in 2010, was a clinical trial that tracked Xarelto's side effects on more than 14,000 patients at nearly 1,200 participating sites located in 45 nations. The experiment compared the performance of Xarelto (rivaroxaban) against that of an older blood thinner called warfarin.

A part of the results of that study were explained this way: "There was a significantly higher rate of major or non-major clinical GI bleeding in rivaroxaban- versus warfarin-treated patients."

The authors' conclusion read, in part, "In the ROCKET AF trial, rivaroxaban increased GI bleeding compared with warfarin."

The study has been brought up in one Xarelto lawsuit after another. For instance, a lawsuit filed by the surviving spouse of an Idaho woman who died in 2013 referenced the clinical trial.

The patient died slightly more than a month after using the drug. She "suffered a hemorrhagic stroke and internal bleeding," according to the complaint.

"Defendants' boxed warning," a part of the lawsuit reads, "did not address the increased risk for serious and fatal bleeding, despite the fact that the information listed on their website originating from the Rocket AF clinical trial sponsored by Defendants, states that in comparison to warfarin, patients taking Xarelto have more gastrointestinal bleeds and need more transfusions. In spite of this reference regarding bleeds, the information is still wholly inadequate because this information was not conveyed in the boxed warning on the Xarelto label."

And this part of the allegation leads to defendants' marketing, which has come under federal scrutiny for downplaying Xarelto side effects.

"In the January/February 2013 issue of WebMD magazine," the lawsuit reads, "Defendants placed a print advertisement that resulted in the Office of Prescription Drug Promotion of the U.S. Food and Drug Administration sending a letter stating that their print advertisement was 'false or misleading because it minimizes the risks associated with Xarelto and makes a misleading claim.' ... As a result of Defendants' intense marketing, '[a]bout 130,000 U.S. prescriptions were written for Xarelto in the first three months of 2012' resulting in large profits as Xarelto costs approximately $3,000 a year versus $200 for generic warfarin."

Patients who suffered severe bleeding after using Xarelto have the option of speaking with an attorney about whether they should be compensated for their medical expenses and for other losses. For a free consultation, contact one of the Xarelto attorneys at Reich & Binstock by clicking this link to visit the Contact page of this website. If you prefer to call, the number is 1-866-LAW-2400.

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