The U.S. Food and Drug Administration (FDA) announced on Friday the approval of the anti-blood clotting drug Savaysa as treatment for patients with atrial fibrillation that is not caused by a heart valve problem.
Atrial fibrillation is characterized with an irregular and fast beating of the heart's upper chambers which can lead to blood clotting. Research presented at the American Heart Association's Scientific Sessions 2013 revealed that about 4.6 million hospitalizations in the United States between 1998 and 2010 were due to atrial fibrillation. And this number is rising steadily for both men and women.
Savaysa was tested in a study involving more than 21,000 participants who were diagnosed with atrial fibrillation that is not caused by a heart valve problem. The drug's performance was compared to another anti-blood clotting drug warfarin.
The clinical trial showed that Savaysa achieved he same effectiveness of warfarin in reducing the risk of stroke, but Savaysa showed lesser bleeding compared to warfarin.
"In patients with atrial fibrillation, anti-clotting drugs lower the risk of stroke by helping to prevent blood clots from forming in the heart," said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research, in a press release. "It is important to have a variety of these types of drugs available as options for patients."
Aside from treating atrial fibrillation, the FDA approved the drug for other conditions such as deep vein thrombosis (DVT) and pulmonary embolism (PE) who have received an anti-blood clotting treatment through injection or infusion before.
The Japanese drug also showed some side effects including bleeding and anemia. There is no drug yet to reverse these side effects so its Boxed Warning contains important dosing and safety instructions to guide both the doctors and the patients.
