Some Recent Articles Point Out the Real Problems And Consequences Of Major Bleeding Events Involving Eliquis, Savaysa, And Xarelto
As many of you know from direct-to-consumer advertising on television, there is a new class of anticoagulant drugs, or blood thinners, which are touted as being safer and more convenient than Coumadin or warfarin.
Among the blood thinners in this new drug class are Eliquis (apixaban), Savaysa (edoxaban), and Xarelto (rivaroxaban).
But there is one fact that is given less attention in those TV ads: To this point in time there is no way to quickly restore normal clotting for patients in need of emergency surgery or to stop a major bleeding episode while on Eliquis, Savaysa, and Xarelto.
A few recent articles address this fact from the perspective of medical doctors who might prescribe Eliquis, Savaysa, and Xarelto as well as emergency room doctors who may have to treat patients on these newer anticoagulant medicines.
From the this December 23, 2015 Reuters news report, "New blood thinner 'antidote' to help doctors move past warfarin", we get some insight about this current "no antidote" situation:
Xarelto, from Bayer AG and Johnson & Johnson, and Eliquis, sold by Bristol-Myers Squibb and Pfizer, were approved as safer and more convenient alternatives for preventing blood clots and strokes than warfarin.
But there was one hitch: there was no way to quickly restore normal clotting for patients in need of emergency surgery or to stop a major bleeding episode, leading many doctors to hold off on prescribing the drugs.
"It may be uncommon, but they're memorable when they happen," Dr. Charles Pollack, an emergency physician at Thomas Jefferson University Hospital in Philadelphia, said of major bleeding events.
"We didn't have a specific reversal strategy for these drugs, and I think that left people feeling a bit insecure," added Pollack, who has done clinical work on a recently approved antidote to Boehringer Ingelheim's rival blood clot preventer Pradaxa....
"I have many physicians, particularly surgeons, who hate these drugs. They're frightened of them because they've had to deal with the consequences of somebody coming in with trauma," while using the new blood thinners.
And so as to punctuate that point, in this same Reuters article, Dr. Mariell Jessup, a cardiologist at the University of Pennsylvania Medical Center, said this: "I have many physicians, particularly surgeons, who hate these drugs. They're frightened of them because they've had to deal with the consequences of somebody coming in with trauma [while using the new blood thinners].'
To provide more detail, we have two items from the December 17, 2015 edition of The New England Journal of Medicine (subscription required).
First, from an Editorial piece, "Antidote for Factor Xa Anticoagulants":
Oral anticoagulant options have exploded. [Pradaxa (dabigatran)], a direct thrombin inhibitor, was approved for use in the United States in 2010...; this was rapidly followed by approval of the direct factor Xa inhibitors [Xarelto (rivaroxaban), Eliquis (apixaban), and Savaysa (edoxaban)] within 5 years.... Although these new drugs represent an important advance in anticoagulation therapy, concern over the lack of antidotes has tempered enthusiasm for their use among both patients and physicians because of the perception of better safety with warfarin as a result of the availability of effective reversal strategies. The need for antidotes, however, was quickly appreciated.
And, second, as regards how that need for an antidote for Eliquis, Savaysa, and Xarelto was "appreciated", from an Original Article piece, "Andexanet Alfa for the Reversal of Factor Xa Inhibitor Activity":
Anticoagulation-related major bleeding is associated with an increased risk of death and thrombotic events, independent of the class of anticoagulant used. Patients who receive factor Xa inhibitors may also be at increased risk for bleeding if emergency surgery is required. With the increasing use of factor Xa inhibitors, the number of patients who require reversal of the anticoagulant effects is anticipated to rise. Therefore, a specific antidote that can rapidly reverse the anticoagulant effects of factor Xa inhibitors in patients who are bleeding or who require emergency surgery is needed. [footnotes omitted] [emphasis added]
Lastly, here is a list of our three most recent reports about the real problems and consequences of major bleeding events involving Eliquis, Savaysa, and Xarelto"
- Is Eliquis Safer Than Xarelto And Pradaxa If It Causes Fewer Dangerous Major Bleeding Events
- Xarelto, Savaysa, Pradaxa, And Eliquis: Safety Secondary To Ease Of Use Is "A Major Wrong Turn" Says Drug Watchdog Group
- Still No Approved Reversal Agents Or Antidotes For Eliquis, Savaysa, And Xarelto To Stop Acute Bleeding
We are currently investigating potential drug injury lawsuits involving Eliquis, Savaysa, and Xarelto for patients who had uncontrollable bleeding, some of whom died, unfortunately.