Like Eliquis, Xarelto, And Pradaxa, This New Blood-Thinner Is Being Sold By Drug Companies At A Time When Profits May Be Taking Priority Over Patient Safety
Savaysa (edoxaban) is from the drug company Daiichi Sankyo, Inc.
Savaysa is the fourth new oral anticoagulant (NOAC) that has been brought to the US market in recent years before any so-called "antidote" was approved by FDA -- like Pradaxa, Xarelto, and Eliquis.
In a January 2015 FDA News Release that significant drug-safety issue was acknowledged. From this item, "FDA approves anti-clotting drug Savaysa", we get the following relevant information:
The U.S. Food and Drug Administration today approved the anti-clotting drug Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem....
The most common side effects observed in clinical trial participants were bleeding and anemia. As with other FDA-approved anti-clotting drugs, bleeding, including life-threatening bleeding, is the most serious risk with Savaysa. There is no treatment that has been proven to reverse the anti-coagulant effect of Savaysa... [emphasis added]
We have written several articles over the past year about the irreversible bleeding "side effect" of this new class of blood-thinning drugs in the context of Eliquis, as seen here:
More recently there was a Milwaukee Journal Sentinel / MedPage Today investigation which resulted in this news report by John Fauber and Coulter Jones, "New anticoagulant drugs provide stroke prevention with dose of danger".
Strictly Confidential, No Obligation.
From that in-depth examination of this serious safety issue -- which is, unfortunately, mostly unknown by patients until it is literally too late -- we get this information:
Xarelto is one of four anticoagulants approved since 2010 that make up a class of drugs known as novel (or newer) oral anticoagulants, NOACS (pronounced No-aks) for short. Widely promoted as more convenient than warfarin, the drugs came to market with much fanfare anticipating blockbuster status.
But unlike warfarin, which is a vitamin K antagonist that can be turned off in a bleeding emergency or prior to surgery by administering vitamin K, all of the NOACs were approved without an antidote, although packed red blood cells can slow their anticoagulation action....
And later in that same investigative report we get these disturbing facts:
Concerns about the new drugs causing bleeding that could not be stopped have been raised for years:
■ In a 2011 letter to the New England Journal of Medicine, doctors in Houston warned about trauma patients using Pradaxa who had poor outcomes because of excessive bleeding. They described one patient who fell and died a short time later.
■ In a 2012 letter in the Journal of Neurosurgery, doctors in Salt Lake City warned of a similar case involving an elderly man who fell and suffered a brain hemorrhage.
■ In a 2014 paper in a hematology journal, doctors in Detroit reported a case of a 39-year-old woman who developed severe vaginal bleeding while on Xarelto. The bleeding eventually was stopped, but the doctors warned: "With the ever increasing number of patients using these new oral anticoagulants, the frequency of acute bleeds similar to our case encountered by physicians will continue to rise."
Now, with Savaysa starting to get some market share in the US, we expect to hear about Savaysa-related injury and death cases which involve people who had excessive bleeding, some who bled to death. And, again, this is because Savaysa -- like Pradaxa, Xarelto, and Eliquis -- does not have an FDA-approved antidote, yet, for a patient experiencing a trauma-induced bleeding event or needing emergency surgery.