Praxbind (idarucizumab) has been given accelerated approval by the Food and Drug Administration (FDA). The FDA has approved it only for patients who have been taking the anticoagulant Pradaxa (dabigatran) under emergency conditions wherein there is a need to reverse Pradaxa’s blood-thinning effects.

For some patients, the anticoagulant effects of Pradaxa are vital and life-saving, mainly for the ones going through emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects because of uncontrollable bleeding.

FDA first approved Pradaxa in 2010, for the prevention of stroke and systemic blood clots in patients suffering from atrial fibrillation, and to treat and prevent deep venous thrombosis and pulmonary embolism.

Praxbind is the first ever reversal agent that has been approved by FDA particularly for Pradaxa, and functions by attaching to the drug compound for neutralizing its effect.

Praxbind solution is to be used for intravenous injection. But, the agency has given a warning that although patients gets exposed to the risk of blood clots and stroke from their underlying disease (like atrial fibrillation) by reversing the effect of Pradaxa, at times doctors are left with no choice but to administer it.

Even then, Praxbind pack’s labeling is recommending patients to continue their anticoagulant therapy as soon as medically appropriate, as said by their health care provider.

FDA said that three trials were done to study the safety and effectiveness of Praxbind. A total of 283 healthy volunteers taking Pradaxa (the ones who did not require an anticoagulant) participated in the trials.