July 6, 2016 — Lawyers representing people who were severely injured by Xarelto are ripping apart clinical trials Janssen Pharmaceuticals used to justify once-daily dosing, according to the The Pennsylvania Record.
When Xarelto was approved in 2011, it was marketed as superior to warfarin. A major selling-point was that Xarelto only needed to be taken once a day.
The problem with once-daily dosing is that the concentration of Xarelto in the bloodstream fluctuates dramatically over the course of 24 hours. Twice-daily dosing is associated with more consistent concentrations.
At the “peak” concentration, patients are more likely to bleed. At the “trough,” patients have little protection against blood clots until they take another pill — but patients commonly forget to take their pill.
Xarelto was studied as a once-daily or twice-daily medication in two Phase II clinical trials. Janssen Pharmaceuticals insists that once-daily dosing was more appropriate.
However, an attorney representing people who were injured called the studies “a total mess” and likened it to an elementary school science fair project.
“Once-a-day (dosing) is better for marketing, but marketing doesn’t trump basic biology. It’s not hard to see how those kinds of fluctuations can both increase the risk of bleeding when concentrations are high and make the drug less effective for preventing clots when the concentrations are low.”
More than 850 lawsuits have been centralized in the Philadelphia Court of Common Pleas. In addition, about 6,000 federal Xarelto lawsuits have been centralized in MDL No. 2592 in the U.S. District Court for the Eastern District of Louisiana, where the first trials are scheduled for February 2017.
All of the lawsuits accuse Janssen of downplaying the risk of severe bleeding. In April 2015, Xarelto was associated with at least a doubled risk of bleeding compared to warfarin in a study published by the British Medical Journal.
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