The findings of research touting the safety of certain medical devices and drugs, including one now involved in Xarelto bleeding lawsuits, are often not published in medical journals with complete accuracy, a new report finds.
According to a report published in an early February issue of JAMA: Internal Medicine, certain problems in clinical trials conducted by drug manufacturers is often not reported to medical journals that publish their results. Written by an affiliate of the Arthur L. Carter Institute of Journalism at New York University, the report indicates that the U.S. Food and Drug Administration (FDA) often finds falsified data and trial misconduct in these studies, which is altogether referred to as Official Action Indicated (OAI) that is not told to publications that report them.
On such instance occurred in a study that was conducted to garner clearance for the blood thinner, Xarelto. According to the JAMA report, a study of the blood thinner that was referred to as RECORD 4 was completely rejected by the FDA because it was led so inefficiently, but its results nevertheless appeared in a 2009 issue of The Lancet, a British medical journal. The findings published there failed to mention that the FDA had found falsified data in the study and even threw out medical records, which was probably done to ward off speculation that Xarelto is unsafe.
In 2011, Xarelto received FDA approval to prevent strokes and other heart problems in patients with atrial fibrillation. The drug was later cleared to prevent deep vein thrombosis and pulmonary embolism in individuals who may be susceptible to blood clots after a knee or hip replacement surgery.
Given the revelations surrounding this medication, may not come as a surprise that numerous adverse event reports have since been filed in the U.S., not to mention several Xarelto lawsuits. These complaints allege internal bleeding episodes that may be uncontrollable since there is no available antidote to stop them once they begin.
A number of Xarelto internal bleeding lawsuits were recently centralized in a multidistrict litigation (MDL) underway in the U.S. District Court, Eastern District of Louisiana. This proceeding was established in December 2014 and included at least 220 lawsuits by the end of this month.
Call an attorney for more about Xarelto internal bleeding. If you or a loved one sustained this or another complication of the anticoagulant, you may be eligible to file a lawsuit: .