Modern blood thinners are among the most highly-prescribed drugs in the country. More than 5 million American patients are taking factor Xa inhibitors to lower the risk of suffering another heart attack or stroke, or to treat a myriad of conditions from irregular heartbeats and heart disease, to lupus and blood vessel disease.
Blood thinners are considered a first-line defense against deadly blood clots known as deep vein thrombosis, which could occur if you’re overweight, recently had surgery, or received an artificial heart valve.
Newer products like Eliquis, Pradaxa, Savaysa, and Xarelto entered the market in the early 2010s as an alternative to the decades-old warfarin. Patients sought an alternative to warfarin because it required frequent blood monitoring tests and dietary changes. Warfarin’s potency also decreases when used in combination with more than 120 common drugs like aspirin, acetaminophen, ibuprofen, antacids, laxatives, antifungal creams, and cold or allergy medicines.
Blood Thinner Antidote in Short Supply
Andexxa (andexanet alfa) was developed by Portola Pharmaceuticals and FDA approved in May 2018 as the only known antidote to reverse bleeding in patients taking factor Xa inhibitors. Its release came after tens of thousands of lawsuits shed light on the fact that, previously, there had been no known antidote for drugs like Pradaxa, Eliquis, and Xarelto, causing some patients to uncontrollably bleed to death. Any type of accident, ranging from a car accident or a gunshot wound to a laceration or a hemorrhage, could cause a person on Eliquis to bleed to death. Patients taking warfarin face the same risks, but its effects can be instantly reversed with a widely available shot of vitamin K that almost every hospital carries.
Even though Andexxa is now on the market, its $24,000 price tag and brief 24-month shelf life have kept it from being carried by hospitals. According to Portola Pharmaceuticals, only about 3 percent of patients hospitalized for bleeding were treated with Andexxa over the past year. Instead, hospitals have tried to use the more affordable and available Kcentra, a prothrombin complex concentrate, to reverse the effects of factor Xa inhibitors, but it’s considered an off-label use, and it’s not always effective.
Andexxa is the only FDA-approved reversal agent for factor Xa inhibitors.
The cost of the drug is somewhat unavoidable, as it’s made using Chinese hamster ovary cells, in a highly complex small-batch process. Researchers are working on ways of affordably scaling up to meet demand, but it’s still a work in progress. However, the refusal to stock up on Andexxa is unacceptable when you consider Portola allows distributors to provide Andexxa to hospitals on consignment. In other words, hospitals can stock up on Andexxa without upfront payment – paying only after they administer the product to a patient, and drugs that expire can be returned for full credit.
Only 4,000 of the 150,000 Xa factor inhibitor patients with bleeding-related hospital admissions are treated with Andexxa each year. With more than 2,000 factor Xa inhibitor-related deaths per month, the question many are asking is: how many deaths are preventable?
Patients on Eliquis Face Limited Emergency Medical Care Options
Consider the heartbreaking story of the Ruggles family. Phil Ruggles ate a healthy diet, exercised, monitored his blood pressure, and led a vigorous lifestyle before suffering a sudden tear in his aorta. Doctors at French Hospital Medical Center in San Luis Obispo, California, said he would have to stop taking his prescription Eliquis for at least two days before they could operate on him because they had no antidote on hand. They ultimately scheduled a helicopter transfer to USC Medical Center in Los Angeles, where they had the antidote, but Phil died of internal bleeding complications in-flight. The family says they’ll never know whether Andexxa and prompt surgery would have saved him, but as his wife, Joanne put it: “If it was your loved one lying in the emergency room, bleeding internally, wouldn’t you want every option that you could have?”
The family is filing a lawsuit to shed light on this little-known risk of modern blood thinners.
Can You Sue the Hospital for Not Having Andexxa?
Consumers have to demand better. In some cases, it’s possible to sue medical care providers for the failure to treat you or your loved one adequately. You may contact Showard Law Firm for a free consultation if you or a loved one have suffered ill effects from the lack of an available Xarelto, Pradaxa, Savaysa, or Eliquis. Your personal injury attorney works on a contingency basis, meaning you pay nothing upfront and only owe a legal fee if your case results in a settlement or jury award. There is nothing to lose and everything to gain from exploring your full set of legal options.
Additional resources:
- https://gmr.scholasticahq.com/article/7777-beginning-to-understand-the-cost-effectiveness-of-andexxa
- https://www.cardiovascularbusiness.com/topics/vascular-endovascular/reversal-agent-factor-xa-inhibitors-receives-accelerated-approval-fda
