This past fall, news broke that a study published in the New England Journal of Medicine comparing the safety and effectiveness of Xarelto and warfarin may be tainted due to a faulty measuring device and missing data.
Now, questions are arising about whether the makers of Xarelto, Bayer and Johnson & Johnson, were complicit in keeping the data from the journal’s editors.
Xarelto is the best-selling drug in a new class called Novel Oral Anticoagulant Drugs (NOADs), which are designed to replace the traditional blood thinner warfarin with fewer dietary restrictions and blood testing needs.
All three drugs in this class: Xarelto, Pradaxa and Eliquis – come with bold marketing claims that they are as safe or safer than warfarin. However, all have been plagued with safety concerns and thousands of patient lawsuits since their launches from 2010 to 2012.
To date, the FDA has received over 6,500 reports of patients suffering internal bleeding while using Xarelto, and nearly 900 reports of patient death.
And, after a record $650 million settlement to Pradaxa bleeding victims last year, attention has turned to new lawsuits against Xarelto for similar internal bleeding injuries that are scheduled to start early next year.
Against this backdrop comes claims that Bayer and Johnson & Johnson, who jointly market Xarelto, may have concealed the fact that the clinical trials published in NEJM, which helped the drug gain FDA approval, had missing data.
Bayer and J&J conducted the three-year clinical trials for Xarelto through Duke University’s Clinical Research Institute, using more than 14,000 patients. In September, it was discovered that a blood-testing device used on the control group of patients taking warfarin had malfunctioned.
In a letter claiming the faulty device was inconsequential, Duke researchers then failed to disclose a finding that data from 5,000 patients had been sent to a different laboratory during the trial, and not submitted to NEJM for the published study.
The New England Journal of Medicine has said that it was not aware of the missing data for 5,000 study participants before this month.
Lawyers for those families injured by Xarelto bleeding claim the companies helped conceal the data from the NEJM by not disclosing its absence, at the same time they had submitted it to the FDA and European Medicines Agency to seek approval.
For more information on the warnings and side effects related to Xarelto, or to speak with a lawyer about the ongoing litigation, contact us today.
Thomas, K. Document Claims Drug Makers Deceived a Top Medical Journal. The New York Times. (March 1, 2016). Retrieved from www.nytimes.com
Marcus, M. Did heart drug makers withhold data from leading medical journal? CBS News. (March 2, 2016). Retrieved from www.cbsnews.com
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