On June 23, 2017, a new anticoagulant drug called BevyxXa (betrixaban) was approved by the FDA for the prevention of venous thromboembolism and pulmonary embolism.
This drug acts as a direct Factor Xa inhibitor, similar to the other anticoagulant drugs Eliquis, Savaysa, and Xarelto.
Unlike the anticoagulant Pradaxa, which is a direct thrombin inhibitor, none of the Factor Xa inhibitors currently have FDA-approved reversal agents.
The article “Still No Approved Reversal Agents Or Antidotes For Eliquis, Savaysa, And Xarelto To Stop Acute Bleeding” by attorney Thomas Lamb provides additional information on this topic.
Due to the lack of adequate reversal agents for these drugs, many Eliquis, Savaysa, and Xarelto lawsuits across the country have been filed by those who have suffered life-threatening uncontrollable bleeding, or by the families of those that have lost their lives as a result of such bleeding.
The current drug label for BevyxXa (6/23/17) already includes the following warning regarding its risk of bleeding events, excerpted from the “Warnings and Precautions” section of the label:
BEVYXXA increases the risk of bleeding and can cause serious and potentially fatal bleeding. Promptly evaluate any signs or symptoms of blood loss…
Concomitant use of drugs affecting hemostasis increases the risk of bleeding. These include aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, and nonsteroidal anti-inflammatory drugs (NSAIDs) [see Drug Interactions (7.2)].
Advise patients of signs and symptoms of blood loss and to report them immediately and seek emergency care. Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement. Discontinue BEVYXXA in patients with active pathological bleeding.
There is no established way to reverse the anticoagulant effect of BEVYXXA, which can be expected to persist for at least 72 hours after the last dose. It is unknown whether hemodialysis removes BEVYXXA. Protamine sulfate, vitamin K, and tranexamic acid are not expected to reverse the anticoagulant activity of BEVYXXA.
Even though recent drug labels for Eliquis, Savaysa, and Xarelto contain similar warnings, many people believe that such warnings are insufficient, and need to be strengthened by making them “black-box warnings.” These are the strictest warnings put in the labeling of prescription drugs or drug products by the Food and Drug Administration (FDA) when there is reasonable evidence of an association of a serious hazard with the drug.
Additionally, it is particularly worrisome that the anticoagulant effects of BevyxXa can last for up to 72 hours after the last dose. To put this into perspective, the effects of Eliquis, Savaysa, and Xarelto only last up to 24 hours after the last dose is taken.
While this may not seem significant, it can make the difference between being able to perform a life-saving surgical procedure within 24 hours versus 72 hours on a patient who is uncontrollably bleeding due to one of these drugs.
Given that the most common adverse reactions with BevyxXa in clinical trials so far have been bleeding events, one may expect lawsuits similar to those of other anticoagulant drugs arise after the drug is released this year.
We will continue to monitor the medical literature concerning BevyxXa and its risk of bleeding, and continue to report additional findings.
Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
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