Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
Recently, controversy has arisen over what to call the novel oral anticoagulant class of drugs, which includes Pradaxa, Xarelto, Savaysa, and Eliquis. The article "NOAC, DOAC, or TSOAC: What Should We Call Novel Oral Anticoagulants?" provides some interesting information about the different sides of this debate.
Here is a list of the possible acronyms used in reference to these drugs:
- NOAC: Novel Oral AntiCoagulants
- NOAC: New Oral AntiCoagulants
- NOAC: Non-vitamin K Oral AntiCoagulants
- DOAC: Direct Oral AntiCoagulants
- TSOAC: Target-Specific Oral AntiCoagulants
- ODI: Oral Direct Inhibitor
- SODA: Specific Oral Direct Anticoagulant
As you can see, the list of possible acronyms is quite extensive. While NOAC is the most common acronym, there has been much debate over what the "N" should stand for. Originally, it stood for "novel," because the way these newer oral anticoagulants worked was "novel" and "new" in comparison to the way previous oral anticoagulants worked.
While warfarin reduces clotting factor production, and heparin (and its derivatives) bind to antithrombin III to induce anticoagulation, Pradaxa, Xarelto, Savaysa, and Eliquis function differently. Pradaxa binds directly do clotting factor IIa (thrombin), and the other three bind directly to clotting factor Xa. This direct binding was the inspiration for the DOAC, TSOAC, ODI, and SODA acronyms.
However, given that there are now several different oral anticoagulants that work this way, they are no longer novel, and many are calling for a name change. In fact, the "N" in NOAC has recently been changed to mean "non-vitamin K."
Some criticize the NOAC acronym entirely, given that it could be misconstrued to mean "NO AntiCoagulants," which could pose life-threatening risks to patients. Though such concern for the dangerous implications of this acronym seem valid, I find it perplexing is that the medical community is debating semantics while patients using these drugs are suffering life-threatening bleeding events and other injuries due to the lack of antidotes for Xarelto, Savaysa, and Eliquis.
While Pradaxa has an FDA-approved reversal agent called Praxbind, there are still no FDA-approved antidotes for Xarelto, Savaysa, or Eliquis. While the use of Prothrombin Complex Concentrates (PCC) or other procoagulant reversal agents sometimes acts as an effective way to reverse the effects of Xarelto, Savaysa, and Eliquis, such methods have not been evaluated in clinical outcome studies. Additionally, even though AndexXa (andexanet alfa) has been shown to reverse the effects of both Xarelto and Eliquis in clinical trials, the FDA recently rejected the manufacturer's application to market it.
Of great concern is that "Portola Pharmaceuticals estimates that up to 100,000 factor Xa patients per year suffer from emergency events that could require a factor Xa antidote," according to this article from The Motley Fool. Such events include, but are not limited to:
- Serious / Irreversible Fatal Bleeding Events
- Trauma-induced Atypical Bleeding Incidents
- Gastrointestinal (GI) / Rectal / Cardiac Bleeds
- Brain / Intracranial Hemorrhages
- Hemorrhagic Stroke
- Heart Attacks
- Myocardial Infarction (MI)
- Acute Coronary Syndrome (ACS)
If you or someone you know have taken Xarelto, Savaysa, or Eliquis and suffered one of the aforementioned side-effects, please fill out the appropriate free case evaluation form, using the links below, to learn whether you may have a possible case.
If you would like to learn more information about these drugs, please visit our website using the links below:
We will continue to monitor the medical literature concerning these particular oral anticoagulants and their future possible antidotes.
Drug Injury Watch: Side Effects News & Reports
Drug Injury Law: Medical & Legal Information