A New York Times journalist found evidence that could demonstrate that Bayer and Johnson & Johnson (J&J), the pharmaceutical companies that manufacture Xarelto (rivaroxaban), already knew about the serious dangers associated with the medication. The number of lawsuits filed recently reached an impressive amount. Over 5,000 total litigations have been brought to court, with at least 500 of them alleging patients’ deaths. Among the various side effects of Xarelto, the bleeding accidents did, in fact, represent the vast majority. Since that they cannot be reversed because no antidote is available, many patients under treatment with this drug suffered significant harm and even permanent injuries.
The drug’s safety and effectiveness were tested in a famous clinical trial, the ROCKET-AF trial, which compared rivaroxaban to Warfarin. Findings from this trial provided sufficient evidence to demonstrate that Bayer’s blood thinner was the better choice to prevent strokes and blood clots formation in patients with Atrial Fibrillation. Thanks to the results of this trial, the United States Food and Drug Administration (FDA) granted approval to the drug on July 2011. Earlier this year, in February 2016, researchers from the Duke Institute that performed the ROCKET-AF trial, provided a new in-depth analysis of the new blood thinner’s efficacy and safety outcomes after five years of use. The results of this new point-of-care monitoring have been published in The New England Journal of Medicine and confirmed previous findings of rivaroxaban’s purported superiority over Warfarin.
However, it seems that the Duke Insitute researchers withheld relevant laboratory data. A footnote in a legal briefing allegedly showed that Bayer and J&J were accomplices with the Duke researchers in hiding precious information from the editors of the science journal. The idea that the Big Pharma was concealing some data from the peer reviewers can be the proof of something needs to be hidden about the drug’s dangers. Xarelto lawyers wish to know the truth on behalf of their clients, as this outstanding truth may as well be used in court as a substantial evidence about Bayer’s negligence in warning the public about the medication’s dangers.
Article written by: Dr. Claudio Butticè, Pharm.D.
Published: 2016/04/13
