According to a recent report on clinical trial misconduct, the seriousness of Xarelto bleeding complications may have been falsified in a clinical Xarelto side effects study. The report suggests that major issues were covered up in one early study on the drug, including signs that data regarding the safety of the anticoagulant may have been falsified and subsequently destroyed.

In early February, JAMA Internal Medicine published a report by Charles Seife, of the Arthur L. Carter Institute of Journalism at New York University, revealing that the U.S. Food and Drug Administration (FDA) frequently uncovers clinical trial misconduct and discrepancies in drug studies conducted by drug makers. However, this information is rarely reported to medical journals who publish the research.

Consequently, the studies are published in the medical journals without any indication that the FDA found issues such as falsified data, unsafe practices, and a complete disregard for scientific protocols. These events are typically referred to as Official Action Indicated (OAI).

Throughout the course of his research, Seife found that most FDA clinical trial inspection records were filled with blacked out sections removing the name of the drugs, companies and researchers, making it difficult to see which clinical trials had major problems — with the exception of Xarelto.

FDA Concerns Over Xarelto Clinical Studies

Janssen Pharmaceuticals, a division of Johnson & Johnson, submitted an approval application for Xarelto (rivaroxaban) to the FDA’s Center for Drug Evaluation and Research in January 2011. Although the FDA ultimately approved Xarelto, the FDA expressed concern over the results of a series of clinical studies, known as the “ROCKET” trials, conducted by the company. Specifically, the FDA found several problems with data integrity.

According to the report, one of the Xarelto side effects study reports — RECORD 4 — of the ROCKET trials was conducted so poorly that the FDA rejected it entirely when deciding whether or not to approve the next-generation anticoagulant. While this particular study states that Xarelto is safe and effective for the prevention of deep vein thrombosis and pulmonary embolism after knee replacement surgery, it fails to reveal that the FDA knew researchers falsified some of the data and destroyed medical records, which was allegedly done to cover up questionable practices.

In 2011, Xarelto received FDA approval for the prevention of strokes among patients with atrial fibrillation. The indication was later expanded to include the prevention of deep vein thrombosis and pulmonary embolism after knee and hip surgery, which is exactly what the RECORD 4 trials aimed to achieve. However, the FDA refused to use the information contained in RECORD 4, claiming the data integrity was so poor it could not be considered in Xarelto’s approval process.

The FDA noted that inspections at five clinical trial sites revealed that researchers did not report adverse Xarelto side effects experienced by patients, didn’t maintain adequate medical records, failed to acquire proper consent from subjects, and didn’t report unanticipated risks to human test subjects.

“Eight of 16 FDA inspections of sites involved in a clinical trial of rivaroxaban, a novel anticoagulant, had been rated OAI. These inspections had uncovered evidence of various transgressions, such as ‘systemic discarding of medical records,’ unauthorized unblinding, falsification, and ‘concerns regarding improprieties in randomization,’” Seife wrote.

“Consequently, the entire study, RECORD 4 (Regulation of Coagulation in Orthopedic Surgery to Prevent Deep-Venous Thrombosis and Pulmonary Embolism 4), was deemed unreliably by the FDA. These problems are not mentioned in the article describing the study’s results or in other publications associated with the trial.”

The result of this report and other Xarelto studies and adverse drug reports, many consumers have decided to pursue Xarelot lawsuits.

Xarelto Bleeding Complications

These accusations of falsifying Xarelto studies come on the heels of mounting Xarelto class action lawsuits involving uncontrolled internal Xarelto bleeding, for which there is no antidote. Other known Xarelto side effects include:

• deep vein thrombosis
• gastrointestinal bleeding
• pulmonary bleeding

Plaintiffs claim that Xarelto manufacturers downplayed this major risk in an effort to boost sales and this new revelation may confirm that they did indeed put profits before consumer safety.