Stop the Bleeding – FDA Approves Praxbind® – Reversal Agent for Pradaxa®
April 7th, 2016|
Pradaxa® is an anticoagulant drug used for the prevention of stroke, blood clots in patients who undergo total hip replacement surgery or total knee replacement surgery, treatment of deep vein thrombosis and pulmonary embolisms, and the prevention of recurrence of such events in adults. Clinical use of Pradaxa equates to over four million patient-years in all licensed indications worldwide. Pradaxa has been on the market for more than 6 years and is approved in over 100 countries.
Lawsuits are mounting concerning the use of Pradaxa. Until recently, if a patient’s blood became too thin while taking Pradaxa, they had a significant risk of bleeding to death because, unlike the older blood thinner Warfarin, nothing could stop the bleeding.
Now, there is some hope for patients taking Pradaxa. The first FDA approval of a specific reversal agent. Praxbind® immediately reverses the anticoagulant action of Pradaxa in situations involving emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding.
Some studies indicate that the reversal effects of Praxbind were evident immediately, within minutes after administration of 5 grams of Praxbind. Perhaps if Praxbind had existed when Pradaxa was approved by the FDA, many lives could have been saved.