Blood thinners and anti-coagulation drugs sometimes lead to internal bleeding and blood clots. Established blood thinners like warfarin (Coumadin) have carefully established prescribing protocols that allow doctors to protect their patients and to deal with adverse side effects when they are taking the drug.
Xarelto (rivaroxaban), one of a newer class of blood thinners, is prescribed for patients suffering from atrial fibrillation (arrhythmia of the heart) and to prevent blood clots, deep vein thrombosis (DVT) and pulmonary embolism in patients who are undergoing knee or hip replacement surgery. Xarelto is an alternative to warfarin (Coumadin), an anticoagulant that has been on the market for more than 60 years.
Deep vein thrombosis occurs when a blood clot forms in the veins deep in the leg. If a part of the clot breaks off, it can be swept into the bloodstream and become lodged in the lungs. This is known as a pulmonary embolism and may be a life-threatening condition.
Xarelto and the drugs in its class are marketed as being more convenient for the patient than warfarin because these drugs do not have the blood-testing requirements or dietary restrictions warfarin users must comply with. But while there is an antidote to internal bleeding with warfarin, there is no known antidote to Xarelto bleeding, making Xarelto bleeding events potentially more dangerous.
Patients taking Xarelto (rivaroxaban), Eliquis (apixaban), Pradaxa (dabigatran) or Lixiana (edoxaban) should be alert to the drugs’ risks:
- internal bleeding
- pulmonary embolism
- heart attack
- brain hemorrhage
Patients should consult a doctor if they experience the following:
- frequent nose bleeds
- unusual bleeding from the gums
- menstrual bleeding that is heavier than normal
- vaginal bleeding
- bleeding that is severe or cannot be controlled
- red, pink or brown urine
- bright red or black stools (looks like tar)
- coughing up blood or blood clots
- vomiting blood or vomit looks like “coffee grounds”
- headaches, feeling dizzy or weak
- pain, swelling, or new drainage at wound sites
The FDA advises that individuals may have a higher risk of bleeding if taking Xarelto in addition to other medicines that increase the risk of bleeding. Such medications include:
- aspirin or aspirin containing products
- non-steroidal anti-inflammatory drugs (NSAIDs)
- warfarin sodium (Coumadin, Jantoven)
- any medicine that contains heparin
- clopidogrel (Plavix)
- other medicines to prevent or treat blood clots
The FDA recommends that patients consult a doctor or pharmacist if they are unsure if a medicine they are taking falls in the categories above.
Patients who have experienced serious Xarelto bleeding events have filed lawsuits against Janssen Pharmaceuticals, Xarelto’s manufacturer. In December 2014, the United States Judicial Panel on Multidistrict Litigation centralized 21 Xarelto legal actions, transferring them to the Eastern District of Louisiana, before Judge Eldon E. Fallon, for coordinated or consolidated pretrial proceedings. In 2015, Judge Fallon issued a number of pretrial orders, including two orders requiring the parties to preserve emails, text messages and instant messages relating to the litigation.