SOURCE: U.S. Food and Drug Administration, news release, Oct. 16, 2015
FRIDAY, Oct. 16, 2015 (HealthDay News) -- Emergency use of a drug to reverse the blood-thinning effects of another drug has been approved by the U.S. 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.
"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.
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).
Praxbind is an injected drug that is the first reversal medication approved specifically for Pradaxa. In three clinical trials involving over 280 volunteers who did not require a blood thinner, those who received Praxbind showed an immediate reduction in the amount of Pradaxa in their blood that lasted for at least 24 hours. The most common side effect was headache.
Another study included 123 patients who were taking Pradaxa and received Praxbind because they had uncontrolled bleeding or required emergency surgery. The blood-thinning effects of Pradaxa were fully reversed in 89 percent of the patients within four hours of receiving Praxbind. The most common side effects were low potassium, confusion, constipation, fever and pneumonia.
The use of Praxbind to reverse the blood-thinning effects of Pradaxa puts patients at risk for blood clots and stroke, and they should resume taking Pradaxa as soon as possible, the FDA said.
Both Praxbind and Pradaxa are marketed by Boehringer Ingelheim of Ridgefield, Conn.
The U.S. National Library of Medicine has more about blood thinners.