August 12, 2014 — Johnson & Johnson’s Janssen Pharmaceuticals unit and Bayer HealthCare have been hit with a lawsuit from a woman who developed severe, life-threatening bleeding after taking Xarelto (rivaroxaban), a popular new blood-thinning medication.
She is seeking financial compensation for her pain and suffering, medical expenses, permanent injuries, decreased quality of life, and ongoing medical care.
According to the complaint, Janssen is liable for her injuries because the drug-maker failed to adequately warn about the safety risks of Xarelto. Janssen is also accused of failing to adequately test Xarelto before marketing it as safe and effective for the prevention of strokes and blood clots.
Since Xarelto was introduced in 2011, it has become one of the most popular drugs in a new class of blood-thinning medications that are rapidly replacing warfarin, a blood-thinner that has been on the market since the 1950s. Unlike warfarin, however, Xarelto cannot be reversed with dialysis or a dose of Vitamin K.
The concern is that doctors who treat Xarelto patients who start bleeding may not be able to stop the bleeding. Another concern is that Xarelto has been linked to a higher risk of gastrointestinal bleeding.
The lawsuit cites a warning letter (PDF) issued by the FDA for “false or misleading” advertisements for Xarelto. The FDA found that some ads made misleading claims about the need for dosage adjustments and omitted risk information.
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