Drug giants Johnson & Johnson and Bayer Pharmaceuticals are facing major scrutiny for allegedly falsifying Xarelto side effects data provided to a medical journal for a study.

The companies allegedly omitted critical information regarding the blood thinner drug and the potential complications it could induce.

Even though Xarelto was approved back in 2011, it was not until recently that The New York Times’ Katie Thomas noticed a footnote in a federal legal briefing.

The footnote indicated that Johnson & Johnson and Bayer Pharmaceuticals may have left out critical data when a peer reviewer at the New England Journal of Medicine had requested it.

Peer reviewers are vital to medical studies, as they are responsible for evaluate the data that is collected to determine that the study’s conclusion is accurate. So when the peer reviewer was denied this information, it incited major concern in the medical community.

The peer reviewer had requested information from a safety and efficiency test of Xarelto, which was conducted months after concern over adverse Xarelto side effects. The study had analyzed how the drug compared to Warfarin in efficiency, along with potential Xarelto problems that may have been just as serious as Warfarin bleeding complications.

However, it has recently been discovered that a recalled blood-testing device had been used in the study. The study in question was led by the recently assigned FDA commissioner Dr. Robert Califf, who is facing major criticism for his alleged role in tampering with the results and for using his numerous connections to the pharmaceutical industry to regulate it.

Recently researchers from Duke University, where the study was conducted, had reviewed their study once again and concluded that the recalled blood-testing device did not impact the study’s results. Even if the results would not have been different without that blood-testing agent, critics state that omitting such information is problematic.

“The claim… that industry influence led to the concealing of data — carries echoes, some experts said, of an earlier era of drug marketing, when crucial clinical data went missing from journal articles, leading to high-profile corrections and a wave of ethics policies to limit the influence of drug companies on medical literature,” Thomas stated.

The FDA and the European Medicine Agency are both investigating into whether or not the recalled blood-testing device could have affected Xarelto’s approval.

Xarelto Side Effects, Bleeding Complications

This study comes as problematic to many patients and physicians, as a number of injury reports describing Xarelto side effects have led to serious injuries and even death. Xarelto was approved in the midst of the major litigation movement of its predecessor Pradaxa over bleeding problems.

Similar to Pradaxa, the adverse Xarelto side effects reported by patients, indicate uncontrollable internal bleeding injuries that often require emergency intervention. Many of the Xarelto problems, along with other new anticoagulants, stem from the fact that there is no approved bleeding reversal agent to remedy bleeding events associated with Xarelto side effects.

Currently, Bayer and Johnson & Johnson are facing major litigation over alleged Xarelto problems patients reported. The company is currently the target of over 5,000 Xarelto side effects lawsuits, with 500 of them involving patient deaths.