A drug to reverse the blood-thinning effects of the popular pill Pradaxa, has been approved by the Food and Drug Administration.
Praxbind (idarucizumab) was cleared for use in patients who are taking the anticoagulant Pradaxa (dabigatran) when there is an urgent need to reverse Pradaxa's blood-thinning effects.
Pradaxa is prescribed to prevent stroke and blood clots in people with a common heart rhythm disorder called atrial fibrillation, and for the treatment and prevention of deep venous thrombosis and pulmonary embolism (which usually occurs when clots that form in veins break free and travel to the lungs).
The original drug, from Boehringer Ingelheim, was approved in 2010 to reduce the stroke risk in patients with irregular heartbeats, or atrial fibrillation. But unlike other blood-thinning medications, there was previously no antidote to stop the drug's effect.
In 2014, Boehringer agreed to pay $650 million to settle roughly 4,000 claims alleging that the company did not warn the public about the risks of uncontrolled bleeding with Pradaxa.