Drug Information Update - FDA approves the first reversal agent for the anticoagulant Pradaxa

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The U.S. Food and Drug Administration today granted accelerated approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.  

The FDA approved Pradaxa in 2010 to prevent stroke and systemic blood clots in patients with atrial fibrillation, as well as for the treatment and prevention of deep venous thrombosis and pulmonary embolism. Praxbind is the first reversal agent approved specifically for Pradaxa and works by binding to the drug compound to neutralize its effect. Praxbind solution is for intravenous injection.

The safety and effectiveness of Praxbind were studied in three trials involving a total of 283 healthy volunteers taking Pradaxa (i.e., people who did not require an anticoagulant). In the healthy volunteers who were given Praxbind, there was an immediate reduction in the amount of Pradaxa in participants’ blood (measured as unbound dabigatran plasma concentration) that lasted for a period of at least 24 hours. In this study, the most common side effect from use of Praxbind was headache.

Another trial included 123 patients taking Pradaxa who received Praxbind due to uncontrolled bleeding or because they required emergency surgery. In this ongoing trial, based on laboratory testing, the anticoagulant effect of Pradaxa was fully reversed in 89 percent of patients within four hours of receiving Praxbind. In this patient trial, the most common side effects were low potassium (hypokalemia), confusion, constipation, fever and pneumonia.

Reversing the effect of Pradaxa exposes patients to the risk of blood clots and stroke from their underlying disease (such as atrial fibrillation). The Praxbind labeling recommends patients resume their anticoagulant therapy as soon as medically appropriate, as determined by their health care provider.

For more information, please visit: Praxbind