WALTHAM, Mass. — New evidence suggests Xarelto’s manufacturers manipulated clinical trial data to discredit a widely used anticoagulant and promote their product.
The study, which appeared in the New England Journal of Medicine, reportedly relied on a defective blood-testing device to compare Xarelto with warfarin. As a result, doctors in the trial might have incorrectly dispensed warfarin and skewed the results in favor of Xarelto.
Dr. Jeffrey Drazen, the NEJM’s editor, insisted the faulty device did not alter the trial and that the journal stood by the published results.
The uncertainty over the test results came to light in a response filed by the drugmakers, Johnson & Johnson and Bayer, to keep records in the 5,000-plus cases confidential. A footnote in that filing called the study results into question.
These lawsuits are already under scrutiny, as Dr. Robert Califf, the current head of the Food and Drug Administration, led the Xarelto clinical trials on behalf of the drug makers.
Xarelto Side Effects
This drug may be the anticoagulant that works too well. Xarelto, which is also known by its scientific name, rivaroxaban, thins the blood to prevent clots, specifically after hip and knee replacement surgery. Doctors also prescribe the drug to patients dealing with pulmonary embolisms (PE) and deep vein thrombosis (DVT). Unlike predecessor anticoagulants, including warfarin, there is no available antidote for Xarelto. So, in the event of sudden and uncontrolled bleeding, doctors are almost completely helpless.
In addition to excessive bleeding, Xarelto has been linked to serious wound infections and other complications, possibly due to the unfettered flow of blood to the surgically-repaired area. In one study, Xarelto patients had a 400 percent higher risk of wound complications than the patients in the control group. Due to these complications, some surgeons have discontinued the drug, and some observers predict that these side-effects will result in a new wave of lawsuits against the manufacturers.
Our Xarelto Lawyers Can Help
Our dangerous drug attorneys can help if you or someone you care about was harmed while taking Xarelto. Lawsuits have been filed against the drug makers by both patients and their families seeking compensation for injuries caused by the dangerous drug. You may be entitled to a settlement.
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