July 6, 2016 — With around 7,000 Xarelto lawsuits now filed and trials set for February, lawyers representing victims are wasting no time in ripping apart the studies Janssen Pharmaceuticals used to justify once-daily dosing.
Janssen conducted two Phase II clinical trials to compare once-daily dosing of Xarelto with twice-daily dosing. The drug-maker concluded that once-daily dosing was more appropriate.
The Pennsylvania Record talked to an attorney who compared the studies to “elementary school science fair projects” and said the dosing recommendations were based on marketing — not safety.
“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.”
Xarelto is a powerful blood-thinning medication that prevents blood clots, but also increases a patient’s risk of bleeding. Unlike the blood-thinner warfarin, Xarelto is only taken once a day. That was a major selling point when Xarelto hit the market in 2011.
The problem with once-daily dosing is that a patient experiences massive fluctuations in blood-concentrations of the drug over 24 hours. At the “peak,” they are more likely to bleed. At the “trough,” they are more likely to experience blood clots. If a patient forgets to take their pill, they rapidly lose protection against blood clots.
Janssen Pharmaceuticals is now facing about 850 Xarelto lawsuits in the Philadelphia Court of Common Pleas. Another 6,000 lawsuits are pending in a federal Multi-District Litigation (MDL No. 2592) in the U.S. District Court for the Eastern District of Louisiana. The first trials are scheduled to begin in February.