Xarelto Clinical Trial Errors
The approval process for Xarelto has been called into question after reviews of the clinical trial process found systemic errors. In fact, half of the clinical trial sites for Xarelto received the most severe rating from the US Food and Drug Administration (FDA), indicating that the inspection identified objectionable conditions or practices significant enough to warrant regulatory action.
JAMA recently published an article by Charles Seife, MS, entitled “Research Misconduct Identified by the US Food and Drug Administration – out of sight, out of mind, out of the peer-reviewed literature.” JAMA Inrtern Med., published online February 9, 2015. In the article, Mr. Seife identified issues found by the Food and Drug Administration (FDA) in various clinical trials for drugs.
One of the problem clinical trials involved Rivaroxaban, also known as Xarelto. According to the article, eight of the 16 sites inspected for a clinical trial for Xarelto had significant problems. The article reported that the FDA found problems such as “systemic discarding of medical records… and concerns regarding improprieties in randomization.”
According to the article, the entire study was deemed unreliable by the FDA. Yet, these problems were not mentioned in the medical article that discussed the clinical trial.
This is a significant issue because this study was a large part Xarelto received approval for use in patients undergoing surgery to prevent deep-vein Thrombosis and Pulmonary Embolisms.
Recalled Device Used in Xarelto Clinical Trials
The only clinical trial for Xarelto that allowed it to gain approval for use in patients with atrial fibrillation to deter the development of blood clots has come into question. This clinical trial, known as ROCKET AF, compared patients using warfarin to patients using Xarelto. This clinical trial showed that Xarelto and Warfarin had similar effectiveness, but new information shows that these results may not be accurate.
The effectiveness of warfarin is directly linked to whether the patient is getting the correct dosage of warfarin. During the ROCKET AF trial, Defendants chose to use a device to measure the amount of warfarin in the patient’s body that has now been recalled by the FDA because the device caused incorrect reading of warfarin levels in the patient’s body. Thus, a question has arisen whether the results of the ROCKET AF trial are valid because of incorrect use of warfarin during the trial.
The Food and Drug Administration is investigating whether the results of the ROCKET AF trial are still valid. In the Xarelto litigation, we are also demanding documents and taking depositions on this same issue. The validity of the ROCKET AF trial is a key question to whether Xarelto is safe and effective for use in patients with atrial fibrillation. We will continue to investigate this important safety issue.
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