According to an observational study published in JAMA Internal Medicine, people taking Xarelto (rivaroxaban) may be more likely to have a serious bleeding event than those taking Pradaxa (dabigatran). Johnson and Johnson (J&J) is facing more the 15,000 Xarelto lawsuits.
For the study, researchers looked at the records of 118,000 Medicare patients with atrial fibrillation (AFib), who took either Xarelto or Pradaxa. Researchers found that there were more serious bleeding events in those taking Xarelto than those taking Pradaxa. This included intracranial hemorrhage, meaning bleeding in the brain, and extracranial bleeding events including major gastrointestinal bleeding.
The researchers also noted that, in 2014, rivaroxaban was prescribed two to three times more often than dabigatran for AFib patients in the U.S., and they said that may be due to doctors falsely believing that Xarelto posed less risk of major bleeding events than Pradaxa.
No Antidote for Xarelto Bleeding
Xarelto is in a class of drugs called novel oral anticoagulants (NOACs). Other NOACs include Pradaxa, Eliquis (apixaban), and Savaysa (edoxaban). Currently, NOACs are used to reduce the risk of stroke in people with AFib. All carry the risk of causing major bleeding events. A reversal agent for Pradaxa was recently approved. There is no antidote for Xarelto, Eliquis, or Savaysa.
Xarelto bleeding is so dangerous because there is no quick way for emergency room doctors to get it under control. Even with immediate medical attention, a Xarelto user can bleed out before treatments can be effective.
Xarelto Reaching for a New Market
The U.S. Food and Drug Administration (FDA) has approved Xarelto for the following uses:
- Help prevent stroke in people with non-valvular AFib
- Treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE)
- Prevent blood clots in hip and knee replacement surgery
Xarelto makers want to market the drug to a new population of patients. They recently ended a trial that studied the safety and efficacy of using Xarelto to prevent cardiac events including heart attack and stroke in patients with coronary artery disease (CAD) or peripheral artery disease (PAD). In February, 2017, Bayer AG and Janssen Research & Development, LLC announced in a press release that they had ended the study early due to "overwhelming efficacy."
If you or someone you love has suffered a major bleeding event while taking Xarelto, you can learn more about your rights and how you can recover damages for your losses by contacting us today.