For the first time in 50 years, a drug has been found that will replace Coumadin

The FDA announced this week the approval of Pradaxa, a new drug for the prevention of stroke among patients suffering from arrhythmias such as atrial fibrillation

Good news for Israelis who take the old drug Coumadin, due to arrhythmias, who are forced to adhere to a special diet and frequent blood tests. The Food and Drug Administration of the United States, the FDA, announced this week the approval of Pradaxa, a new drug to prevent strokes among patients suffering from atrial fibrillation. The new drug, which is an advanced anticoagulant of its kind, will be an effective and safe alternative to Coumadin, the conventional drug for which no substitute has been found in the last fifty years. The FDA's decision was made following a revolutionary breakthrough in an extensive international study that followed for about two years 18,113 patients collected from 44 countries around the world, including Israel, and was recently published in the New England Journal of Medicine. The study proved that the new drug called Predaxa is clearly superior to Coumadin in preventing strokes and systemic embolisms and, unlike Coumadin, does not require a special diet, dose adjustment or frequent blood tests. The Israeli part of the study was led by Prof. Basil Lewis, director of the cardiology department at the Carmel Medical Center and the outgoing chairman of the Cardiology Association in Israel, and 689 Israeli patients from 29 medical centers across the country participated. Atrial fibrillation is a heart rhythm disorder that is sometimes accompanied by shortness of breath, chest pains, a general bad feeling and a significant decrease in quality of life. The disorder significantly increases the risk of forming blood clots in the heart cavity due to a change in blood flow. The main goal in the treatment of atrial fibrillation is to protect the brain since the clots that form may reach the heart through the blood vessels to the brain and cause a stroke.

Paradexa was developed by the Beringer Ingelheim company in Germany and is marketed in Israel through the Rafa Laboratories company. The drug was already approved in Israel about a year ago at a lower dose for a different indication of preventing blood clots after orthopedic surgery and the Rafa Laboratories company has already started registering it and submitting it to the health basket also for the prevention of stroke among patients with atrial fibrillation at a dose approved by the FDA - 150 mg twice a day.

According to estimates, about 7 million people worldwide live with atrial fibrillation. About 3 million people worldwide suffer from a stroke related to atrial fibrillation every year. About 100 women and men in Israel suffer from atrial fibrillation, about 15 different strokes, including strokes, occur in Israel, 55% of them among men and 45% among women, and about 30 Israelis are treated in Israel with Coumadin because of atrial fibrillation-type arrhythmias.