FDA Backs Xarelto Despite Flawed Clinical Trial
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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.