Researchers hid clinical trial evidence of Xarelto side effects, FDA investigation reveals

by Eric Pearson

Allegations of misconduct in clinical trials for the bloodthinner Xarelto have led some critics to wonder whether the drug should have ever been approved by the Food and Drug Administration (“FDA”). Among other allegations, the FDA reportedly found that Bayer researchers failed to report cases of serious adverse events among patients involved in clinical trials for Xarelto. Although the drug was later approved by the FDA, several patients who experienced major bleeding events after taking Xarelto have filed lawsuits against Bayer and its subsidiaries.

Xarelto received approval from the FDA in 2011 as a way of lowering the risk of stroke in patients with atrial fibrillation. The agency later expanded this approval to use for the prevention of deep vein thrombosis (DVTs) and pulmonary embolism (PE) for patients who have undergone hip or knee surgery.

Xarelto was intended as an alternative for Coumadin, a drug which had been used for decades for the prevention of blood clots. However, unlike Coumadin, Xarelto had no known antidote, meaning that there was no way for doctors to administer drug treatments that could stop major bleeding events in patients who were taking the drug.

A report recently published in the medical journal JAMA Internal Medicine found that in addition to these health risks, the FDA also uncovered major instances of misconduct in connection with clinical trials for Xarelto. These misconduct allegations were so serious that they caused the FDA to reject a study of Xarelto known as RECORD 4 because the data it contained was so unreliable.

According to the JAMA report, FDA investigators that reviewed the RECORD 4 clinical trial results uncovered evidence that researchers falsified data and destroyed medical records related to patients taking Xarelto. Reports have suggested that these alleged violations may have occurred in order to conceal evidence of the risk of major bleeding events associated with Xarelto. FDA investigators rated eight of the 16 Xarelto clinical trial sites reviewed by the agency as Official Action Indicated (OAI)—meaning that issues such as falsified data, unsafe medical practices, and disregard for scientific protocols had been observed at the site.

Despite concerns from the FDA about clinical trial evidence for Xarelto, Bayer was able to have the RECORD 4 study results published in Lancet, a leading British medical journal. The publication made no mention of the FDA’s concerns about the accuracy of clinical trials for Xarelto or the risk of major bleeding events associated with the bloodthinner that had been raised by the agency.

The JAMA study also reported that the FDA completely rejected the RECORD 4 study when reviewing Xarelto for approval, stating that the data in the study was so unreliable that it could not be included in the agency’s approval process. Among other allegations, the FDA stated that researchers during the clinical trial failed to properly report side effects from Xarelto that were experienced by patients, failed to maintain proper medical records, failed to properly obtain medical consent from subjects in the study, and failed to report dangers associated with Xarelto to subjects in the study.

Xarelto Lawsuits Filed On Behalf of Victims of Serious Bleeding Events

Lawsuits filed against Bayer, Janssen, and their subsidiary companies by patients who suffered major bleeding events after taking Xarelto have accused the drugmakers of deliberately hiding information about the dangers of the bloodthinning drug from doctors and patients. These Xarelto lawsuits have alleged that Bayer knew about the dangers of Xarelto years before this information was known to the public, yet failed to warn patients about the health risks they might face from taking the bloodthinner drug.

Patients who have suffered gastrointestinal bleeding or other major bleeding events caused by the use of Xarelto may be eligible to file a lawsuit and receive compensation for medical expenses and other losses caused by their injuries. The first step in filing a lawsuit against Xarelto is to speak with an experienced pharmaceutical liability attorney about your case.

The attorneys with the law firm of Heygood, Orr & Pearson have based their careers on the idea that the manufacturers of defective drugs and dangerous medical devices should be held responsible for their actions. Our firm has represented hundreds of individuals who have been harmed by dangerous drugs, including the fentanyl patch, Yaz birth control, Actos, Avandia, and Accutane.

The lawyers at Heygood, Orr & Pearson are trial attorneys in the truest sense. We are as comfortable before a judge and jury as we are drafting a legal brief. In fact, every one of our attorneys has trial experience, ranging from auto accident cases to commercial fraud cases to pharmaceutical liability cases. Our attorneys have tried over 200 cases to verdict and we have achieved verdicts and settlements for our clients totaling more than $200 million. We are all committed to bringing the highest standards of ethics and a passion for justice to every client and every case.

If you or a loved one has been injured by the use of drugs such as Xarelto or other medical products, contact the lawyers at Heygood, Orr & Pearson to find out more about how we can help with your case. For a free legal consultation and to find out more about whether you may qualify to file a lawsuit, call us toll-free at 1-877-446-9001, or by following this link to our free case evaluation form.