Xarelto

Proposed Xarelto Antidote AndexXa Denied FDA Approval

Xarelto antidote AndexXa

The U.S. Department of Health and Human Services says that4.2 million Americans aged 18 and older use prescription blood thinner medications. Anticoagulant patients spend nearly $1 billion annually on their prescription medications. Despite a number of competing products, Xarelto carries the lion’s share of the market. Upon its 2011 Food and Drug Administration (FDA) approval, Xarelto quickly earned $864 million. Johnson & Johnson CFO Dominic Caruso says the product’s success is due to its clinical profile as well as placement “in the formularies … so that patients can access these products.” While Xarelto seems like it’s set to replace top anticoagulant warfarin, one major flaw is causing prescribing physicians to take a second look. The proposed Xarelto antidote AndexXa was initially fast-tracked for FDA approval, but recently denied due

Proposed Xarelto Antidote AndexXa Would Have Addressed the Current Lack of Reversal Agent

Although Xarelto has some side effects (fainting, itching, pain in your arms and legs, muscle pain and spasms, etc.), the main concern for healthcare providers is its lack of reversal agent. Despite its “blood thinner” moniker, Xarelto doesn’t actually thin blood. Instead, it works by preventing a natural blood protein called factor Xa from clotting blood. The main problem is that Xarelto prevents blood clots a little too well. In fact, serious bleeding episodes with Xarelto can sometimes lead to death. This is especially worrying when a patient requires emergency surgery or undergoes a major bleeding episode.

“It may be uncommon, but [major bleeding episodes are] memorable when they happen,” says Dr. Charles Pollack, emergency physician at Thomas Jefferson Hospital in Philadelphia.

Warfarin (also known as Coumadin) dominated the prescription anticoagulant market for decades. That is, until a new wave of blood thinners (including Pradaxa and Xarelto) arrived. While warfarin had its downsides, it’s also possible to reverse Coumadin’s anticoagulant properties and prevent patients from bleeding out. Administering Vitamin K to a warfarin patient easily reverses its anticoagulant effect. Vitamin K, unfortunately, is not a viable Xarelto antidote. AndaxXa is the first Xarelto antidote that’s been developed, but it hasn’t yet been approved.

One study reviewed commonly used anticoagulant antidotes, such as Vitamin K used for reversing warfarin. It expresses concern for Xarelto’s widespread use: “A growing problem arises from the increasing use of new anticoagulants that lack specific antidotes.” The study adds that should be mindful about prescribing these drugs: “Thus, careful choice of an anticoagulant agent and laboratory monitoring where appropriate are needed to minimize the risk of bleeding complications.”

Xarelto Antidote AndexXa Would’ve Helped Allay Growing Concern From Physicians

One of Xarelto‘s selling points is no need for monthly blood monitoring. Xarelto’s marketing touts, “Spend your time how you want to spend it, with no regular blood monitoring.” But no monitoring or Xarelto antidote worries some doctors. Dr. Alan Jacobson, director of anticoagulation services at Veterans Administration (VA) healthcare system in Loma Linda, CA, says “The good news is you now have an alternative to warfarin… The bad news is you can kill a patient just as easily with the new drug as you could with the old drug.” He and 12 other physicians worry about real-world Xarelto and Pradaxa use. That’s because these anticoagulants don’t require regular blood monitoring or frequent follow-up visits. Without these measures, patients have a higher risk of stroke, serious bleeding episodes, and blood clots. These risks are especially high for patients with poor kidney function.

Xarelto’s lack of reversal agent is even more alarming. Dr. Sanjay Kaul, cardiologist at Cedars-Sinai Medical Center in Los Angeles, says “What really compounds the matter is the lack of a specific antidote to reverse life-threatening bleeding.” Dr. Kaul served on independent panels advising the FDA on both Pradaxa and Xarelto. He also added that he refused to prescribe Xarelto as a result of the research he’d done in that advisory capacity. And Dr. Mariell Jessup, cardiologist at the University of Pennsylvania Medical Center, concurs: “I have many physicians, particularly surgeons, who hate [Xarelto and Pradaxa]. They’re frightened of them because they’ve had to deal with the consequences of somebody coming with trauma.”

Xarelto Antidote AndaxXa News: Put on FDA Fast Track, No Approval

Drug maker Portola Pharmaceuticals manufacturers a drug called andexanet alfa (AndexXa) that supposedly reverses Xarelto’s effects. Portola applied for FDA approval of its Xarelto antidote AndexXa back in 2015. Doctors were hopeful that the drug might quickly be approved to help prevent potentially extreme Xarelto bleeding episodes. Labeling it as a “breakthrough therapy,” the FDA expedited AndexXa’s review in the hopes that it would be fast-tracked to the U.S. market. Upon review, the FDA decided they needed more information before approval. This leaves Pradaxa the only new wave blood thinner available that currently has an FDA-approved antidote.

On August 18, 2016, Portola announced the FDA did not approve its Xarelto antidote AndexXa. Since AndexXa is the only drug developed for patients taking a Factor Xa inhibitor (such as Xarelto), no viable Xarelto antidote exists. Therefore, the risk of bleeding out during a life-threatening situation is still a major concern for Xarelto patients. Portola’s shares fell 12% in value following the FDA announcement.

What You Can Do

Because Xarelto’s manufacturer failed to properly warn consumers about the risk of life-threatening side effects as well as failing to develop a viable antidote, lawsuits are now pending. Other anticoagulants (including warfarin and Pradaxa) have antidotes to reverse major bleeding episodes. However, many consumers weren’t made aware of this extreme possibility before taking Xarelto.

If you or a loved one took Xarelto and suffered a major bleeding episode or other life-threatening condition, you may be eligible for compensation. To see if you may have a claim, fill out a free Xarelto case review today.