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Savaysa Can Cause Severe Bleeding And Major Bleeds That Cannot Be Controlled, Events Which May Lead To Deaths

 

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Savaysa® (edoxaban) is a relatively new blood thinner medicine from the drug company Daiichi Sankyo, Inc.

At the time that Savaysa was approved by the FDA in January 2015, it was known there was not any treatment available to effectively reverse the anti-coagulant effect of Savaysa. Put otherwise, Savaysa has no antidotes.

From this document , “FDA approves anti-clotting drug Savaysa”, we get the following significant drug-safety information:

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]

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.

We are investigating Savaysa deaths and injury cases which involve people who had severe bleeding problems, some who bled to death.  For example, patients who had emergency surgery or acute bleeding due to trauma could experience irreversible or uncontrollable bleeding because there is no antidote for Savaysa.

Here are some adverse reactions and side effects that may have been caused by the use of Savaysa:

•   Serious Bleeding Events
•   Irreversible Fatal Bleeding Events
•   Trauma-induced Atypical Bleeding Incidents
•   Gastrointestinal (GI) Bleeds
•   Rectal Bleeding
•   Hemorrhages
•   Brain Hemorrhage
•   Intracranial Hemorrhage
•   Hemorrhagic Stroke
•   Cardiac Bleeds
•   Heart Attacks
•   Myocardial Infarction (MI)
•   Acute Coronary Syndrome (ACS)

While a Savaysa antidote will probably someday be available to help patients suffering an acute bleed, unfortunately it will be too late for some people who suffered serious bleeding events or bled to death, already.

Here are some of the personal injury and wrongful death cases involving Savaysa-related bleeding events that we are investigating:

Savaysa – Major Brain Bleed and Stroke – 77 yr old woman
Savaysa – Gastrointestinal (GI) Bleeding – 54 yr old man
Savaysa – Gastrointestinal (GI) Bleed – 80 yr old man
Savaysa – Massive Hematoma – 68 yr old woman
Savaysa – Uncontrolled Gastrointestinal (GI) Bleed; Death – 68 yr old man
Savaysa – Two Subdural Hematomas – 53 yr old man
Savaysa – Cerebral Hemorrhage; Death – 86 yr old man
Savaysa – Serious Bleeding From Kidney – 51 yr old man

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September 2016 Savaysa Label Change Points Out There Is Still No Antidote

Savaysa (edoxaban) is a factor Xa inhibitor which was approved by the FDA in 2015. Savaysa has the following so-called “indications” or approved uses:

  1. To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; and,
  2. For the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5–10 days of initial therapy with parenteral anticoagulant.

In relevant part, from a September 15, 2016 FDA letter to Daiichi-Sankyo, Inc.:

Prior Approval supplemental new drug application provides for changes to SAVAYSA prescribing information based on results of the Phase 1 trial DU176b-A-U158 that evaluated the effects of Prothrombin Complex Concentrate (PCCs) on reversing the pharmacologic activity of edoxaban tosylate. Sections 5.3 ‘Risk of Bleeding’ and 12.2 ‘Pharmacodynamics’ have been updated to include this information.

For some related news as regards the FDA and Savaysa, see this article, “Xarelto / Savaysa / Eliquis: Antidote Drug AndexXa Is Rejected By FDA In August 2016“, over at our Drug Injury Watch blog.

We will continue to monitor the safety profile of Savaysa as well as Eliquis and Xarelto, especially as regards the current lack of any FDA-approved antidote which would act as a reversal agent for serious bleeding events such as intracranial hemorrhages or hemorrhagic strokes and gastrointestinal (GI) bleeds.

[Read this article in full at original source]
 
 
Earlier articles by attorney Tom Lamb on the Side Effects Blog:

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All content by attorney Tom Lamb

Law Offices of Thomas J. Lamb, P.A.
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Wilmington, NC 28403
(800) 426-9535
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