FDA approves drug to reverse blood thinner Pradaxa

AP News
Posted: Oct 16, 2015 5:42 PM

WASHINGTON (AP) — Federal health regulators have approved a drug to reverse the blood-thinning effects of the popular pill Pradaxa, which has been subject to thousands of reports of severe bleeding.

The Food and Drug Administration said Friday the new drug, Praxbind, is an injection that neutralizes the effects of Pradaxa. Patients may need to halt blood thinning if they are injured or require emergency surgery.

"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," said Dr. Richard Pazdur, of the FDA's drug center, in a statement.

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 some 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.

The FDA said it approved Praxbind under its accelerated approval program, which is used to review drugs for serious or unmet medical conditions based on preliminary studies.