Savaysa (edoxaban) 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 about this new blood-thinner drug, however, a 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]
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”, from which we get this disturbing information:
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.
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.[Read this article in full at original source]
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