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article imageThe FDA questions Xarelto safety due to defective device

By Claudio Buttice     Mar 2, 2016 in Health
The U.S. Food and Drug Administration is investigating on the reliability of the ROCKET-AF clinical trial that led to the approval of Xarelto. Despite the European Medicines Agency (EMA) confirming its validity, a defective device may have compromised it.
The Novel Oral Anticoagulant (NOAC) Xarelto is one of the most controversial drugs of the last decade. At first, the new blood thinner received widespread approval when it was approved in 2011, due to its superior compliance and convenient dosage. Xarelto (also known by its chemical name "rivaroxaban") was very popular among doctors and patients thanks to a one-size-fits-all dosing that required a single pill to be ingested every day, regardless of the patient's weight, sex or age. The lack of all the annoying dietary restrictions and continuous blood monitoring required by its older competitor Warfarin also helped its manufacturers Bayer AG and Janssen Pharmaceutical gain a consistent share of the anticoagulants market. However, after just a brief period, rivaroxaban started to raise consistent concerns among both physicians and patients as well.
Xarelto's dangerous side effects reportedly include uncontrolled bleeding accidents that could cause life-threatening injuries to patients who took this medication, and in some instances, even their deaths. Hundreds of patients started filing lawsuits against the pharmaceutical companies, holding them responsible for the injuries they sustained, and asking for proper compensation. Recently the number of total Xarelto lawsuits grew to over 3,000 total litigations, which are being consolidated in the Multidistrict Litigation MDL-2592 in the Eastern District of Louisiana, one of the largest pharmaceutical lawsuits of the last few years.
Recently, however, the scientific soundness of the large clinical trial that led to the approval of this medication, the ROCKET-AF study, has been contested. Regulators found that a defective device was used to monitor the international normalised ratio (INR) in patients, a parameter used to gauge the effectiveness of the anticoagulant to prevent the blood from thinning. The whole ROCKET-AF trial revolved around comparing Xarelto to Warfarin, to determine which one of the two drugs was safer and more effective. The faulty INRatio device readings could have skewed the results in favor of the newer drug, as doctor in the study may have provided their patients with higher doses of Warfarin, leading to an increased number of bleeding accidents.
The ROCKET-AF trial was reviewed by the EMA, the European counterpart of the FDA, which concluded that the faulty device did not significantly undermine the study's validity. Nonetheless, the FDA noted how the EMA panel that investigated on this matter was mostly composed of members of the Duke Clinical Research Institute: the same people who conducted the original trial. Their independence in properly assessing the trial's reliability could be deemed as questionable, especially as although the device was recalled by the FDA in 2014, the researchers never mentioned the opportunity of using central laboratory tests to estimate the devices accuracy. Whether the FDA is going to open a new investigation panel on the ROCKET-AF trial or not is still unclear, although many questions about this study keeps being yet unaddressed.
More about Xarelto, Fda, EMA, US Food and Drug Administration, food and drug administration
 
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