The United States Food and Drug Administration (FDA) approved the use of a new drug which can reverse the blood-thinning effects of the popular pill Pradaxa, a medication for patients with irregular heartbeats or atrial fibrillation.
The FDA said that by injecting the new drug called Praxbind into patients, the effects of Pradaxa will be neutralized. Patients under Praxada who require emergency surgery or had gotten injured are advised to stop using the drug.
"The anticoagulant effects of Pradaxa are important and lifesaving for some patients, but there are situations where the reversal of the drug's effects is medically necessary," said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products at the FDA's Center for Drug Evaluation and Research.
Three clinical trials were conducted involving 280 volunteers who did not require a blood-thinner. Volunteers who took Praxbind showed an immediate reduction in the amount of Pradaxa in their blood that lasted for at least 24 hours. Headache was the most common side effect.
Meanwhile, another study was conducted with 123 patients who were under Praxada. The patients took Praxbind because they had uncontrolled bleeding or they required emergency surgery. In the end, 89 percent of the patients had been successfully neutralized with Praxbind. The noted side effects were confusion, low levels of potassium, fever, constipation and pneumonia.
The FDA suggests that any person experiencing possible symptoms of atrial fibrillation, such as heart palpitation, irregular pulse, chest pain, fatigue and dizziness should immediately consult their doctor.
Over 2.7 million Americans experience atrial fibrillation and are at risk of going into a stroke, according to the FDA. Through anti-coagulants or blood thinners, the risk can be reduced by 50 to 60 percent. Atrial fibrillation is a heart disorder wherein the flow of the blood in the heart's top chambers moves too slowly. This can result in the formation of blood clots, which can eventually lead to stroke.
Pradaxa was a blood-thinning drug marketed by Boehringer Ingelheim in 2010. However, one of its side effects is severe bleeding. In 2014, the company had to pay $650 million to settle roughly 4,000 claims stemming from the lack of information about the drug's side effects.
