FDA Granted Clean Chit to blood thinner xarelto

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Xarelto is associated with serious potential side effects, complications and risks including, brain hemorrhaging, rectal bleeding, intestinal bleeding, blood clots, pulmonary embolism and deep vein thrombosis and in some unfortunate cases death. Despite of the risk associated with drug the U.S. Food and Drug Administration give clean chit to the drug after serious doubts arose over the major study used to gain approval of the drug. On Oct. 11, 2016, the FDA released its reanalysis of the ROCKET AF clinical trial data and states that Xarelto is safe and effective for patients with the heart condition atrial fibrillation. Xarelto received two ‘black box’ warnings from the FDA. These warnings are the strictest warning a product can receive before being pulled completely from the market. As per a statement posted in agency’s websites, The Agency has determined that effects on strokes or bleeding, including bleeding in the head, were minimal.

Earlier this year, in February 2016, researchers from the Duke Institute have 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 test results reveal that the previous findings of rivaroxaban superiority over Warfarin were false. The Duke researchers were hiding valuable information as they were conspirator with Bayer and J&J. According to the studies done by researchers, the drug makers may have reduced the risk of patients dying on Xarelto from uncontrollable bleeding if they had provided stronger warnings and recommended blood monitoring during treatment. As per the data of ROCKET-AF trial from 118,891 patients who were at least 65 with nonvalvular AF. The study reveals that the patient who takes Xarelto had a 15 percent higher chance of death, 65 percent higher chance of brain bleeds and 48 percent increased risk of major brain bleeds.

According to a recent report, more than 9000 pending lawsuits are in process regarding Xarelto alleging the drug has caused uncontrollable and life-threatening internal and external bleeding. Due to the increasing numbers of lawsuits the United States Judicial Panel on Multidistrict Litigation announced that the Xarelto lawsuits will be consolidated for multidistrict litigation. According to the plaintiffs manufacturers withheld information about the lack of an antidote along with the prescribing information and they claims that if the company had warned of the risks, then patients would have been prescribed the drug warfarin, a medication in which internal bleeding can be treated with dosages of Vitamin K.

The number of lawsuit filed from all over the nation alleges that the manufacturers Bayer and Janssen knew or should have known of the risks associated with the drug. If you or your love ones are facing fatal complication due to real brad of Xarelto can take a legal action against the company. He/she can claim for reimbursement money against complication or loss within limited period of time. We have an experience attorneys group who evaluate your case free of cost unless we win the case for you. Contact for free case review.


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