Not long ago, warfarin (brand name Coumadin®) was the only available prescription anticoagulant. Warfarin effectively cornered the blood thinner market for nearly 60 years. But between 2007 and 2011, warfarin treatment visits dropped from 2.1 million quarterly to just 1.6 million. That’s because drug manufacturers introduced four new anticoagulants. Xarelto® is a newer drug stealing warfarin’s patients. Despite no Xarelto reversal agent to treat emergency bleeds for 10 years, it became a top-selling prescription. There’s no need for regular blood monitoring or frequent follow-up visits with Xarelto. So, many doctors now prescribe Xarelto over warfarin. Still, some doctors were hesitant to prescribe it until the FDA approved an antidote in May 2018.
Lack of Xarelto Reversal Agent Until 2018 Made Bleeding Episodes More Dangerous
Longstanding blood thinner warfarin has a reversal agent. During an emergency bleeding episode, doctors simply give the patient vitamin K. Vitamin K reverses warfarin’s blood-thinning effects in order to help clots form. A patient can thus avoid bleeding out, saving the person’s life. Xarelto had no antidote available until May 2018. So, patients taking Xarelto prior to that were literally at risk for death from bleeding out.
How No Antidote Affected Xarelto Patients
If Vitamin K reverses warfarin’s blood-thinning effects, why didn’t it work for Xarelto? Despite marketing Xarelto as a “blood thinner” medication, it doesn’t really thin your blood. Xarelto actually prevents a protein-based component called Factor Xa from clotting your blood. Xarelto does a good job of preventing blood clots and pulmonary embolisms (among other nasty complications). But during a serious bleeding episode, Xarelto patients can die.
Dr. Charles Pollack, emergency physician at Thomas Jefferson University Hospital in Philadelphia, worried about these major bleeding events. “It may be uncommon, but they’re memorable when they happen,” says Dr. Pollack. He explains that some physicians felt insecure about prescribing Xarelto over anticoagulants with reversal agents. Dr. Mariell Jessup, cardiologist at the University of Pennsylvania Medical Center, says: “I have many physicians, particularly surgeons, who hate these drugs. [the four newest blood thinners] They’re frightened of them because they’ve had to deal with the consequences of somebody coming in with trauma.” With no way to clot a Xarelto patient’s blood until May 2018, serious cuts or surgery often led to uncontrollable bleeding.
Xarelto Reversal Agent Finally Approved In May 2018
In 2015, Portola Pharmaceuticals applied for Food and Drug Administration approval of a drug called AndexXa™ (andexanet alfa). AndexXa would quickly reverse anticoagulation effects for Xarelto and Eliquis (apixaban), two Factor Xa inhibitors. Physicians and Portola in particular were excited about finally having a FDA-approved Xarelto reversal agent.
The FDA put AndexXa on an accelerated approval pathway in early 2016. All parties were eager to find a safe, effective antidote for Factor Xa inhibitors. But in August 2016, the FDA turned down an accelerated approval timeline for the drug. The agency sent Portola a letter asking for additional manufacturing information and data. This would support Portola’s request to include direct Factor Xa inhibitor edoxaban and indirect inhibitor enoxaparin on AndexXa’s label. The letter also indicated a need to review clinical amendments to Portola’s post-marketing commitments. Thankfully, the FDA finally approved AndexXa in May 2018.
What A Lack of Xarelto Reversal Agent Meant for Prescribing Doctors
The FDA’s refusal to approve AndexXa until 2018 put many blood thinner patients at risk. Still, other factors come into play beyond needing an emergency bleed antidote. Dr. Sanjay Kaul, cardiologist at Cedars-Sinai Medical Center in Los Angeles, expressed extreme concerns about Xarelto. Dr. Kaul says he received a dozen calls from colleagues about patients bleeding after taking a new wave blood thinner called Pradaxa. He found many physicians didn’t test each patient’s kidney function before prescribing Pradaxa.
When kidneys are weak, medicine excreted by the organ instead builds up to unsafe levels in the patient’s bloodstream. And when kidneys eliminate two-thirds of Xarelto from the patient’s body, internal bleeding risks go up. “What really compounds the matter is the lack of a specific antidote to reverse life-threatening bleeding,” said Dr. Kaul, who served on independent panels advising the FDA about Xarelto and Pradaxa. He urges other physicians to consider each new anticoagulant’s risks before prescribing them to patients.
How Patients With Xarelto Bleeding Injuries Can Qualify for $775 Million Settlement
If you or a loved one developed blood clots or uncontrolled internal bleeding while taking Xarelto, you may qualify for compensation. Fill out your free Xarelto claim review form now. It takes less than two minutes to confirm your eligibility for a cash settlement! An experienced attorney will call to discuss your case once you submit your information.
Related: UPDATED: Portola Pharmaceuticals Gains FDA Approval for AndexXa
Lori Polemenakos is Director of Consumer Content and SEO strategist for LeadingResponse, a legal marketing company. An award-winning journalist, writer and editor based in Dallas, Texas, she's produced articles for major brands such as Match.com, Yahoo!, MSN, AOL, Xfinity, Mail.com, and edited several published books. Since 2016, she's published hundreds of articles about Social Security disability, workers' compensation, veterans' benefits, personal injury, mass tort, auto accident claims, bankruptcy, employment law and other related legal issues.