Xarelto (rivaroxaban), first approved in 2011, is a blood thinner that prevents the formation of blood clots. It’s used to treat a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism).
The blood thinner is also used to treat atrial fibrillation (abnormal heartbeat), or can be used after hip or knee replacement surgery. A common, yet severe, side effect of Xarelto is hemorrhaging. However, due to a complaint involving one sample bottle Johnson & Johnson’s Janssen unit recalled 13,500 sample bottles in October. The recall came shortly after several new lawsuits filed by patients claiming the drug caused uncontrollable bleeding that led to deaths.
Lawsuits Against the Xarelto Stomach Bleeding
Xarelto was approved to reduce the risk of blood clots and strokes and was marketed as being superior to warfarin because patients who take Xarelto do not require regular blood monitoring. However, unlike warfarin, Xarelto currently does not have an approved antidote to reverse side effects of Xarelto.
Lawsuits filed in New York,Vermont and Florida, alleged that patients were not adequately warned about the risk of Xarelto stomach bleeding. These lawsuits blame Johnson & Johnson and Bayer for failing to warn healthcare professionals and patients of the dangers of uncontrolled bleeding, a fact that the drug companies did not publicize.The drug company misled the public into thinking Xarelto was safe. The drug has since been associated with rectal, intestinal and abdominal bleeding as well as hemorrhaging in the brain. Since there is no anecdote, the drug can take up to 24 hours to leave the system. For the elderly, the main target group for Xarelto, it can take longer and be especially dangerous.
According to court documents the FDA received 1,080 adverse event reports linked to Xarelto, including 65 deaths. Although not many have lawsuits have been filed yet, some critics say more will be expected in the coming months.