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 anticoagulant effects of Pradaxa are important and lifesaving for some patients, but there are situations where reversal of the drug's effects is medically necessary," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products at the FDA's Center for Drug Evaluation and Research, said in an FDA news release. "Today's approval offers the medical community an important tool for managing patients taking Pradaxa in emergency or life-threatening situations when bleeding can't be controlled," he added.
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.