For decades, Coumadin (warfarin) was the go-to anticoagulant drug. It was regularly prescribed by physicians to decrease stroke risk in patients with atrial fibrillation. Coumadin also treats and prevents blood clots in the lungs and legs. But newer anticoagulants on the scene prove just as effective, including Pradaxa (dabigatran), Eliquis (apixaban), Savaysa (edoxaban) and Xarelto (rivaroxaban). Deciding which drug is right for you, however, may require a little research. “It’s not a one-size-fits-all choice,” says Bruce Lindsay, MD, of the Cleveland Clinic. “A lot depends on your overall health and your lifestyle.” And while you and your doctor should carefully consider each drug, one new anticoagulant should give both of you pause. That’s because no Xarelto reversal agent is currently available.
Understanding Why Patients Need a Xarelto Reversal Agent
If excessive amounts of a blood thinner exist during a serious bleeding episode (or the drug negatively reacts), anticoagulation must be reversed to prevent bleeding out. Though Coumadin has its drawbacks, there are options for its reversal. These antidotes include withdrawal of oral anticoagulants, fresh frozen plasma, and Vitamin K.
Because no Xarelto reversal agent exists, there’s no way to control the excessive bleeding that can occur when an anticoagulant causes blood to be too thin, and there is no clotting to prevent bleeding out. The inability to quickly restore normal clotting for patients (as had been done in the past with Vitamin K), has led many doctors to hold off on prescribing the drug. Dr. Charles Pollack, an emergency physician at Thomas Jefferson Hospital in Philadelphia, says of the major bleeding events, “It may be uncommon, but they’re memorable when they happen.”
Some physicians are hesitant to prescribe Xarelto without an antidote. But thousands more have prescribed the drug anyway, causing several unnecessary deaths. In 2014, Bloomberg reported in that 65 deaths had been linked to uncontrolled bleeding while using Xarelto because the drug has no antidote.
Why Weren’t Patients Warned About the Lack of Xarelto Reversal Agent?
When Xarelto was released in 2011, the manufacturers of the drug (Bayer AG and Johnson & Johnson’s subsidiary Janssen Pharmaceuticals) advertised the drug to doctors as an easier alternative to Coumadin (or warfarin). Their ‘one-size-fits-all’ attitude made it easy for physicians to overlook the lack of Xarelto antidote. Since the new drugs require less monitoring than Coumadin, they’re appealing to busy physicians. But the lack of monitoring also makes them less predictable.
Of these newest anticoagulants, Doctor Pamela Tronetti said “because we have blood tests that help us calculate the body’s responses to Coumadin, we can individualize the dose. But we cannot measure and anticipate an individual’s response to the direct anticoagulants.”
One of the main selling points of the new anticoagulants, Xarelto included, is freedom from continuously monitoring the patient. But without an antidote, the drug in practice, should be monitored even more carefully, since there is no way to reverse the uncontrolled bleeding.
Due to many Xarelto complications, hundreds of lawsuits are currently pending against Bayer AG and Johnson & Johnson. Patients claim that they were not properly warned about Xarelto’s lack of antidote and that the drugmakers downplayed bleeding risks.
After receiving several Xarelto adverse event reports, the FDA released a report on safety labeling changes in 2014. The FDA boldly states Xarelto’s bleeding risks and orders physicians to “promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement.”
They also mention that there is no specific Xarelto reversal agent available.
Though the warning may have prevented future physicians from prescribing Xarelto, for many, it came too late.
Precedence for Xarelto Injury Lawsuits
The allegations of downplaying Xarelto’s bleeding risks and lack of an antidote for the drug has some precedence. In 2014, a similar settlement occurred where Pradaxa (manufactured by Boehringer Ingelheim Gmbh) faced 4,000 liability lawsuits. Researchers linked Pradaxa to over 500 patient deaths
The corporation settled for $650 million.
Could a Xarelto Warning Have Prevented These Deaths?
The FDA’s black box warning (though important for preventing future Xarelto deaths) can’t undo the damage it already caused. Nor can it undo the marketing tactics by Xarelto representatives that misled physicians into believing the drug was a safe option.
Drug labeling is easily misrepresented. Unlike nutrition or over-the-counter drug labels, pharmaceuticals do not have a nationwide standard. The Federal Food, Drug, and Cosmetic Act requires specific label details (such as the patient’s name and dosage instructions). However, other details vary from state to state. And instead of being monitored by the FDA, each state’s pharmaceutical board oversees and approves the content. As a result, a lot of information and warnings are either misrepresented or completely missing.
Which circles back to the question: Could a warning have prevented deaths?
Short answer: Yes. Long answer: Possibly not.
Because it was brought to market without a Xarelto reversal agent, it’s unclear whether warnings would have prevented any deaths. If physicians were properly warned about the drug’s dangers, they probably would’ve been more hesitant to prescribe it.
What You Can Do
If you or a loved one took Xarelto and suffered a serious bleeding episode requiring a transfusion or possibly death, you may be eligible for compensation. Because drug giants Bayer and Janssen Pharmaceuticals failed to properly warn patients and physicians of the risk of major bleeding episodes and the lack of a Xarelto reversal agent, the product was marketed illegally.
To speak to an attorney and see if you have a case, complete a free Xarelto claim review today. The drug’s manufacturer is being sued for failing to properly warn consumers about potentially life-threatening side effects.