Xarelto Approval Trial Skewed by Faulty Blood Monitor
This is Michael Brady Lynch, lead trial attorney for The Michael Brady Lynch Firm.
In a dramatic turn of events in the sordid saga of the drug Xarelto, the FDA is now questioning the very approval data behind Xarelto’s claims as a miracle drug. Information has surfaced that is leading the FDA to re-examine the results of the sole clinical trial that allowed Xarelto to be approved in the first place.
This single clinical trial showed that the blood thinner, Xarelto was more effective than tried and true warfarin. Manufacturer, Johnson & Johnson even went so far as to claim that it reduced stroke by 35%. These results were so significant, that it helped the FDA fast-tracked Xarelto to approval. Now, internal documents from Johnson & Johnson employees have surfaced outlining their own personal reservations about the legitimacy of this magical clinical trial – mainly the blood monitor used by doctors. They felt that is was malfunctioning, and it wasn’t showing accurate numbers. This caused many doctors to incorrectly prescribe the dosage amounts in the warfarin arm of the trial. This may have led to additional bleeding episodes that gave Xarelto the edge in the study.
Since these documents have become known, the FDA is questioning Johnson & Johnson on their trial results. Adding to the concerns is the manufacturer, Alere, recalled the very same blood monitors used in the study. Alere noted in the recall that the monitor was providing inaccurate results, most notably understating a patient’s risk of bleeding.
Importantly, with Xarelto usage, this bleeding event is usually uncontrollable bleeding. This means that bleeding usually occurs near a major organ (i.e. brain, lungs or kidneys) when blood flow to that organ is halted. The organ will rapidly decrease some or all of its functionality. Pools of blood may start to form within the body. Xarelto prevents clotting, so doctors cannot inject clotting factors into the body to reverse the bleeding. This means that there are few options for doctors to employ when treating the suffering caused by this drug.
Even though the FDA is asking questions, they are still a long way from removing this dangerous drug from the market. A spokeswoman for the FDA was quoted saying that the agency was looking into the issue, but it had not changed any recommendations for the drug.
If you or a loved one suffered uncontrollable bleeding from taking Xarelto, contact us today for a free consultation. 877-513-9517.