The United States Food and Drug Administration, or FDA, has released a press announcement stating that they have approved a drug, Praxbind, to counter the blood thinning effects of Pradaxa in emergency situations.
Pradaxa was approved in 2010 to reduce the risk of stroke and systemic blood clots in patients with atrial fibrillation, or irregular heartbeat. There has been no way to reverse the blood thinning effects of the medication, however.
Last year the maker of the drug, Boehringer, agreed to pay $650 million to settle about 4,000 claims that the company did not do enough to make the risk of uncontrolled bleeding known to patients according to ABC News.
Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, Dr. Richard Pazdur, says that the effects of Praxbind are essential for patients in the case where the effects of Pradaxa need to be reversed.
The anticoagulant effects of Pradaxa are important and life-saving for some patients, but there are situations where reversal of the drug’s effects is medically necessary. 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.
The new drug was approved through the FDA’s accelerated approval program, which allows for faster approval of drugs for serious or unmet medical conditions. The program allows patients earlier access to drugs prior to definitive confirmation of the drug’s clinical benefit.
Three trials studying the safety and effectiveness of Praxbind showed that there was an immediate reduction of Pradaxa in the 283 healthy volunteers and that reduction lasted for at least 24 hours. Headache was the most common side effect of Praxbind.
A trial of 123 patients taking Pradaxa were administered Praxbind because of uncontrolled bleeding or due to emergency surgery. Praxbind reversed Pradaxa’s anticoagulant effect within 4 hours in 89 percent of the patients. This trial had low potassium, confusion, constipation, fever and pneumonia as common side effects.
While Praxbind is reversing the effects of Pradaxa, the patient is left susceptible to the original problems that Pradaxa helps protect from. For this reason, it is important for the patient to get back to anticoagulant therapy as soon as they can.