FDA Backs Xarelto Despite Flawed Clinical Trial

Thornton Law Firm is no longer accepting new Xarelto cases.

By: Marilyn McGoldrick, Esq.

Published on February 1, 2017

Recently, issues were raised concerning the results of a clinical trial for the blood thinning drug Xarelto. It was discovered that a medical device used during the study was faulty and was later recalled. The effect this may have had on the study is especially concerning as more than 13 million prescriptions have been written for the drug nationwide.

Original Xarelto Clinical Trial

The results of the clinical trial in question were published in 2011. That study led to the approval of the drug’s use in patients with atrial fibrillation who were at risk of suffering a stroke. The study included over 14,000 patients and concluded that Xarelto and its predecessor Warfarin both prevented strokes. It also concluded that there was no major difference between the two medications in regards to the risk of major bleeding, although bleeding in the brain occurred less in the group which took Xarelto.

However, in 2014 a medical device used to test for blood clotting during the study was later recalled for giving inaccurate results, a problem that dated back to 2002.

Reviewing the Trial

Although Duke University’s Clinical Research Institute, which conducted the original trial, recently published a letter stating that researchers had reanalyzed the results and stood by their original conclusions, concerns still remain regarding the drug’s risks. For instance, one medical journal hypothesizes that the use of faulty equipment during the study may have led doctors to think the Warfarin levels in certain patients were lower than they actually were. As a result of this misleading data, some patients may have been given additional doses. According to the journal’s editor, this could explain why the older drug caused more bleeding than Xarelto in the trial.

Both the European Medicines Agency and the US Food and Drug Administration reviewed the results of the reanalyzed trial and concluded that the drug was safe. Still, multiple plaintiffs have come forward claiming that the drug’s manufacturer, Bayer, and its marketer, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, failed to warn users of the risks of bleeding associated with Xarelto.

Contact Thornton Law Firm, LLP to Speak With a Dedicated Defective Drug Attorney

If you have experienced internal bleeding as a result of taking Xarelto, you may have a claim for damages. Please contact Thornton Law Firm, LLP at (888) 341-1405 to speak with an experienced attorney who can help you seek the compensation you deserve. All legal claims have short time limits, so do not delay seeking legal advice.

Xarelto Anticoagulant May Be Next Nationwide MultiDistrict Litigation

Thornton Law Firm is no longer accepting new Xarelto cases.

By Marilyn T. McGoldrick, Esq.

Posted on Oct 30, 2014

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The Judicial Panel on MultiDistrict Litigation has been asked to certify a new MultiDistrict Litigation for the plaintiffs alleging injuries and death caused by prescription anticoagulant Xarelto. Since Xarelto was approved by the Food and Drug Administration (FDA) in 2011, doctors and patients have been reporting a number of serious side effects, including severe gastrointestinal and rectal bleeding, causing decreased hemoglobin levels requiring blood transfusions. In 2012 alone, 2,018 adverse events were recorded by the FDA’s MedWatch reporting system, including 151 deaths from uncontrolled bleeding.

Bayer_Logo.svgXarelto (generic name, rivaroxaban) is approved to prevent or treat pulmonary embolism (PE) and deep vein thrombosis (DVT). It is also prescribed to patients with atrial fibrillation to prevent strokes.Patients who have had knee or hip replacement surgery are often prescribed Xarelto to prevent the formation of blood clots. The drug is manufactured by Bayer HealthCare AG and licensed for distribution by Janssen Pharmaceuticals, Inc.

It is suspected that Xarelto leads to significant incidence of gastrointestinal and rectal bleeding that can lead to decreased hemoglobin levels requiring blood transfusions. Most serious Xarelto injuries and deaths arise from internal bleeding. Potential signs of Xarelto internal bleeding are:

  •        Prolonged bleeding from cuts
  •        Unusual swelling or bleeding
  •        Heavy or prolonged menstrual flow
  •        Frequent nose bleeds
  •        Coughing or vomiting up blood
  •        Blood in urine and/stools
  •        Unusual bruising

Xarelto is in a class of drugs called new oral anticoagulants (NOACs) which were sold as alternatives to Coumadin (warfarin) as treatments for a variety of blood clot disorders. The other drugs in the NOAC class are Pradaxa and Eliquis, and all three NOACs do not require regular blood monitoring, which is required of warfarin users. The maker of Pradaxa settled a similar class action in 2014 for $650 million dollars,

Xarelto has been heavily advertised in the media, including being the #1 product advertised in medical journals in 2013. Almost 1 million prescriptions for Xarelto were written in 2013, resulting in almost $2 billion dollars in sales.

If you or someone you love has used Xarelto and suffered serious injury resulting from internal bleeding, our Xarelto injury lawyers can help. Please call our experienced defective drug litigation attorneys at 888-341-1405 or tell us your story here for a free no obligation consultation.

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