UPDATE: (March 3, 2016) – According to a recent New York Times report, Bayer, Johnson & Johnson and those who ran clinical trials at Duke University that eventually led to the FDA approval of Xarelto may have lied to editors at the New England Journal of Medicine.
At issue is a medical device (see Feb. 23 “update” below) that measured the levels of blood thinner in patients involved in the clinical trials. There are serious concerns that those running the clinical trials knew the device was defective but failed to reveal that information. According to the Times, documents produced in pending Xarelto lawsuits suggest that the editors of the New England Journal of Medicine inquired of those running the clinical trials as to whether there were lab tests that confirmed the accuracy of the device (i.e., confirmed it was not defective but instead gave accurate, reliable readings). The editors were told there was not, when in actuality there were such tests. The reason? These Xarelto clinical trial “problems” were first reported in the the BMJ in December, with researchers warning that the device may have led to an underestimation of the rate of Xarelto bleeding complications in comparison to Warfarin. (i.e., making Xarelto appear to be safer – profits over people. ).
UPDATE: (Feb. 23, 2016) – According to a report published by the New York Times on Monday, the U.S. Food & Drug Administration (“FDA”) is actively investigating the clinical trials of Xarelto known as “ROCKET-AF”. According to the article, the FDA has queried Johnson & Johnson in detail over a medical device used in the clinical trial, and about whether they had any indication the one they were using might have been defective – compromising the study and resulting in flawed results as to the safety and efficacy of Xarelto. The malfunctioning device might have led doctors to give patients the wrong dose of a comparison drug, leading to additional bleeding episodes with the comparison drug and giving an unfair advantage to Xarelto (i.e., making Xarelto appear to be safer).
The clinical trial, performed between 2006 and 2010, was led by Dr. Robert M. Califf who is currently President Obama’s nominee for head of the FDA, and involved more than 14,000 patients worldwide.
Xarelto , like Eliquis, is an oral blood thinner that has been linked to a high rate of serious internal bleeding incidents and deaths. Approved for use in patients suffering from atrial fibrillation and recovering from hip and knee replacement surgeries, Xarelto is intended to prevent strokes by reducing the body’s ability to form blood clots.
The most popular anticoagulant is Coumadin (Warfarin) which has been around since 1956. As an older drug that no longer has patent protection it has become a “generic” drug. As a generic drug, pharmaceutical companies, such as the makers of Xarelto (Bayer) have long searched for a Coumadin replacement. Consequently, Xarelto and Eliquis have been aggressively marketed as providing the same or slightly better results than Coumadin in preventing strokes and other blood clot related events, but as superior to Coumadin in that weekly or monthly blood tests are not required.
However, when a patient develops internal bleeding or a hemorrhage while taking Coumadin (Warfarin), the bleed can be stopped with a dose of Vitamin K. When a bleeding event happens with a patient taking Xarelto, it is often uncontrollable, increasing the risk of serious injury or death.
Although Xarelto may allow patients to make fewer doctor visits than older anticoagulants, many agree with the authors of a study published in the Journal of Neurosurgery in August 2014: “Despite their convenience, efficacy and lower (brain bleed) risk, a major limitation of the targeted OACs (oral anticoagulants i.e. Xarelto and Eliquis) is that there is currently no specific antidote for any of the agents.”
If you or a loved one has suffered gastrointestinal bleeding, bleeding of other internal organs, cerebrovascular bleeding or a stroke after taking Xarlelto, contact us online or call immediately at 1-866-252-3535.