Xarelto (rivaroxaban) is a blood thinner manufactured by Bayer, primarily prescribed to prevent stroker and systemic embolism in patients with nonvalvular atrial fibrillation. It is also prescribed to prevent recurrence of deep-vein thrombosis and pulmonary embolism.
Xarelto was approved by by the FDA in 2011. Before its approval, the predominant blood-thinning drug was warfarin. Warfarin is an effective blood-thinner, though patients must undergo regular blood testing to ensure that the dosage is correct — that the blood is sufficiently thinned to help prevent strokes, but not too much.
When Xarelto came to the market, Bayer — the manufacturer — hired Janssen Pharmaceuticals to heavily market that Xarelto was superior to prior blood-thinners because it was a convenient once-daily dose that did not require blood monitoring. This marketing effort was apparently effective as Xarelto topped $1.5 billion in sales in 2014 alone.
But recent studies have shown that Xarelto is less effective than warfarin that has been accurately dosed through regular monitoring — yet Xarelto’s FDA approval was based on a standard of non-inferiority to other blood thinners.
Recent filings in federal court accuse Bayer of overstating the safety of Xarelto and negligently refusing to implement a commonly accepted method to reduce the serious side-effects of blood thinners, blood-monitoring, because it would harm Xarelto’s competitive advantage.
Plaintiffs in these filings have suffered a range of adverse bleeding events, including internal bleeding.