When Xarelto first hit the market in 2011, it gained widespread popularity because it did not require routine blood monitoring like its predecessor, Warfarin. It also had less drug interactions and no dietary restrictions, making it the anticoagulant of choice for many doctors and patients.
What Is Xarelto?
Xarelto is a prescription medication used to prevent blood clots from forming as the result of an irregular heartbeat, also called atrial fibrillation. Xarelto is commonly given after hip or knee replacement surgery, or to patients with other types of blood clots or those who need to prevent past blood clots from forming again. It works by blocking specific clotting proteins in the patient’s blood to reduce clot formation.
All anticoagulants have a risk of excessive bleeding due to the nature of the medication, but some anticoagulants like Warfarin have an antidote to help stop uncontrollable bleeding. However, there is no Xarelto antidote or other consistent means of reversing the effects of Xarelto.
Failure To Warn
The lawsuits allege that Xarelto’s US manufacturer, Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) minimized the bleeding risks associated with the drug and failed to properly warn patients and doctors. In 2012 Janssen received an FDA warning letter stating their print advertisements were “false and misleading” and asked the company to reply with a plan to discontinue the false advertising. The company never responded and continues to use statements the FDA has deemed misleading.
The plaintiffs in the Xarelto lawsuits have suffered from a variety of bleeding events including intestinal bleeding, brain hemorrhaging, rectal bleeding, and other internal bleeding. This has caused some patients to suffer from strokes or even death. While researchers are currently working on a Xarelto antidote, it will come too late for thousands of Americans who have already suffered from Janssen’s failure to warn. The first Xarelto trials are scheduled for early 2017.