Xarelto is the trade name for the oral blood thinner Rivaroxaban which is manufactured by Janssen Pharmaceutica, a subsidiary of Johnson & Johnson, and co-marketed by Bayer. It is a once a day oral medicine that works by inhibiting the body’s normal blood clotting process. Xarelto gets in the way of something called “factor Xa” in the blood, and it lasts for 24 hours after a dose is taken. This means that while it is active the body is not able to create blood clots to stop bleeding. There is no specific way to reverse the effects of Xarelto if there is a major bleeding event while on this medication.
Xarelto is currently FDA approved for the prevention of strokes in patients with atrial fibrillation and either congestive heart failure, hypertension, advanced age, diabetes, or a prior stroke. It is also approved for the prevention of deep vein blood clots (DVT prophylaxis) in patients with hip or knee replacements and the treatment of blood clots and pulmonary embolism and long-term prevention of reoccurrence in these patients.
What is the Basis for a Xarelto Lawsuit?
Xarelto is being marketed against Coumadin (Warfarin), which has long been used in the treatment and prevention of blood clots, and prevention of strokes in atrial fibrillation. What makes Coumadin different is in case there is a major bleeding event while on Coumadin, Vitamin K and/or fresh frozen plasma reverses its blooding thinning effects. This means doctors have a way to stop bleeding which is out of control, and poses a danger of drug injury to the patient.
In contrast, there is no specific way to reverse the blood thinning effect in Xarelto. There is no medicine available that doctors can give to stop the bleeding. The bleeding often continues for 24 hours until the effect of Xarelto ends. This results in bleeding events including gastrointestinal bleeds, and intracranial hemorrhage (strokes) that have a greater likelihood of death or disability.
Ultimately there is a failure to adequately warn consumers of the bad drug risk associated with Xarelto, which makes this drug unreasonably dangerous to the ultimate consumer. Aggressively marketing the benefits to doctors and patients, without adequate drug warnings that explain the significant risk of incurable bleeding, makes this product a dangerous drug.
If you or someone you know has had a serious bleeding event while on Xarelto, contact Greg Vigna, MD, JD to determine if a Xarelto lawsuit can be filed.
Greg Vigna, MD, JD is a Board Certified Physical Medicine and Rehabilitation physician, Certified Life Care Planner, and bad drugs lawyer who understands the medical care you deserve at the time of your adverse event, the medical care you require in the future, and how to obtain just compensations for injuries that result from the negligence of others.