A new reversal agent that is designed to help prevent patients from bleeding to death after taking some anticoagulant medications like Warfarin has been approved by the FDA. However, the new drug, which will be marketed as KCentra, does not work on newer anticoagulants like dabigatran and rivaroxaban.
Both rivaroxaban and dabiagtran have been linked to excessive and uncontrollable bleeding through various studies. On April 29, the FDA announced it was approving Kcentra, which acts as a reversal agent for vitamin k antagonist (VKA) blood thinners like warfarin. Although the only other drug that has been approved to do this is plasma, vitamin K has long been used help treat patients that have suffered from excessive bleeding after taking warfarin. When warfarin patients bleed, doctors give them the vitamin k and big plasma doses as a means of reversing the anticoagulants’ blood thinning effects, which in turn helps stop the bleeding. While Kcentra may be able to eventually act as a replacement for the plasma, it would also have to match a patients’ blood type and be thawed.
“The FDA’s approval of this new product gives physicians a choice when deciding how to treat patients requiring urgent reversal of VKA coagulation,” said Dr. Karen Midthun, director of the FDA Center for Biologics Evaluation and Research. “Kcentra is administered in a significantly lower volume than plasma at recommended doses, providing an alternative for those patients who may not tolerate the volume of plasma required to reverse VKA anticoagulation.”
Bleeding risks have long been a factor with anticoagulants, but some anticoagulants that are used to treat atrial fibrillation and other heart conditions are far more dangerous than that. One of those drugs is Multaq. Multaq is made by Sanofi-Aventis and has been linked to serious side effects including a worsening of the heart condition, liver failure and lung toxicity. It is for this reason that the FDA has recommended that doctors only prescribe Multaq if all other medications fail to work.
If you or a loved one has suffered from liver failure or a worsening heart condition after being treated with Multaq, contact the attorneys at Greg Jones today for a free consultation. I am experienced at fighting Multaq lawsuits and may be able to help you recover money for your injuries