Missing Clinical Trial Data Raises Concerns about Xarelto

When it was first released to the public in 2011, Xarelto was treated like a wonder drug. Since it first came onto the market, it’s estimated that the drug has been prescribed more than 23 million times, netting the manufacturers over $2 billion in sales.


The number of individuals filing Xarelto lawsuits or joining class action lawsuits continues to climb. The anticoagulant drug manufactured by Bayer AG and Johnson & Johnson’s Janssen Pharmaceuticals gained FDA approval in 2011 and quickly became quite popular. At the time it was hailed as a new wonder drug, allowing people who were on it greater freedom than they’d enjoyed while taking any of the other blood thinners previously available. However the shine quickly wore off Xarelto and now it has been named in at least 3,400 lawsuits spanning the United States, with more lawsuits getting filed every single month.

Now, people have raised questions regarding the clinical trials Bayer AG and Johnson & Johnson’s Janssen Pharmaceuticals used prior to seeking FDA approval for Xarelto. Many suspect that the manufacture failed to provide some bits of data that might have prevented it from gaining approval to be sold to the public.

Lawyers have filed paperwork stating that they feel when the New England Medical Journal of Medicine published a report about how Xarelto had performed in clinical trials, some information was missing from the article. The paperwork also maintains that although manufactures, Bayer AG and Johnson & Johnson’s Janssen Pharmaceuticals, were aware of the missing data, they chose to remain silent on the matter, which led credibility to the report.

XARELTO-collage1-300x300In the report, the clinical trial compared how Xarelto and the more traditionally used warfarin dealt with health issues commonly experienced by individuals who used blood thinners. During the clinical trial individuals who had either had strokes or another blood issues took either Xarelto or warfarin. At the end of the trial, the article indicated that Xarelto resulted in fewer fatal bleedings, even though both treatment options produced the same risk of hemorrhaging. Many feel that if doctors had been privy to this one key bit of information, they might not have been so quick to prescribe Xarelto to patients.

Following the clinical trial, one of the devices that had been used to measure the blood clotting process was recalled, forcing Duke to reanalysis the date they’d originally collected. Many experts feel that Duke made a mistake when they failed to compare the freshly analyzed data with the data they’d analyzed with the recalled device to better determine how accurate the original results were. Duke claims that the results are accurate, though it failed to publish the results they collected from the patients who received warfarin during the trial.

Dr. Lisa Schwartz was quick to speak up when she learned about the actual results of the clinical trial. “It just feels like it’s a real ethical breach. If you know the direct answer to this question, then how can you not provide it to be able to give insight?”

When questioned, New England Medical Journal of Medicine, claimed to have not known about the missing data when they published the results.



If you’d like to know more about Xarelto lawsuits, rx injury help is an excellent source of information. If you feel that your health was compromised because you weren’t provided with an adequate understanding about the potentially life threatening side effects connected to Xarelto, contact a lawyer today and learn more about your legal options.