FDA approves Pradaxa
Manufactured by Boehringer Ingelheim to treat abnormal heart rhythm
The US Food and Drug Administration (FDA) has approved the drug Pradaxa (dabigatran) for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation).
More than two million Americans are affected by atrial fibrillation, which occurs when the heart’s two upper heart chambers beat quickly and out of sync, the FDA said. They are at a higher risk of developing blood clots, which can cause a stroke if the clot travels to the brain.
Pradaxa is an anticoagulant that inhibits thrombin, an enzyme in the blood that is involved in blood clotting. Clinical studies of the drug found that patients with atrial fibrillation had fewer strokes on Pradaxa than those taking warfarin, the FDA said.
As with other approved anti-clotting drugs, bleeding, which could be life threatening or fatal, was among the most common adverse reactions reported by patients treated with Pradaxa. Gastrointestinal symptoms, including an uncomfortable feeling in the stomach (dyspepsia), stomach pain, nausea, heartburn, and bloating were also reported.
Pradaxa was approved with a Medication Guide that informs patients of the risk of serious bleeding.
Manufactured by Boehringer Ingelheim, the drug will be available in 75mg and 150mg capsules.