If you’re one of the more than 2 million Americans who have atrial fibrillation – a heart rhythm disorder that increases the risk of stroke and blood clots -- the recently approved anti-clotting drug Pradaxa (dabigatran) may be an effective alternative to standard warfarin treatment.

According to updated guidelines issued in February 2011 by the American College of Cardiology, American Heart Association, and the Heart Rhythm Society, Pradaxa is useful as an alternative to warfarin to prevent stroke and blood clots in patients with either paroxysmal (recurrent episodes that stop after seven days) or permanent (an on-going episode) atrial fibrillation, and with risk factors for stroke or blood clotting who do not have a prosthetic heart valve, significant heart valve disease, severe renal failure or advanced liver disease.

Pradaxa is prescribed as a capsule which is taken by mouth with or without food twice a day.  In order to prevent strokes and blood clots, the drug must continue to be taken exactly as prescribed even if you feel well. If you suddenly stop taking Pradaxa, your risk of stroke may increase. It’s important to read and follow the manufacturer’s information sheet guidelines included with your prescription and consult your doctor or pharmacist if you have any questions.
Benefits of Pradaxa

Since the 1950s, people with atrial fibrillation have commonly been prescribed the anti-clotting drug warfarin, but the drug requires regular testing and dosage adjustments. Pradaxa –which belongs to a class of anti-clotting medications called direct thrombin inhibitors -- does not require such careful monitoring.
In addition, Pradaxa may be more effective than warfarin. When the U.S. Food and Drug Administration approved Pradaxa in October 2010, evidence from a large-scale clinical trial suggested that strokes were significantly less common among atrial fibrillation patients taking Pradaxa than among those taking warfarin.

Side Effects of Pradaxa

Similar to other anti-clotting drugs, Pradaxa is associated with adverse side effects, the most serious of which is life-threatening bleeding. It also may cause gastrointestinal symptoms such as dyspepsia, stomach pain, nausea, heartburn, and bloating.

Tell your doctor if these symptoms are severe or don’t subside:

• Stomach pain.
• Heartburn.
• Nausea.

Call your doctor immediately if you experience any of these potentially serious symptoms:

• Unusual bleeding or bruising.
• Pink or brown urine.
• Red or black, tarry stools.
• Coughing up blood.
• Vomiting material that is bloody or looks like coffee grounds.
• Bleeding from the gums.
• Frequent nosebleeds.
• Heavy menstrual bleeding.
• Bleeding from a cut that lasts longer than normal.
• Joint pain or swelling.
• Headache.
• Dizziness.
• Weakness.
• Hives.
• Rash.
• Itching.
• Difficulty breathing or swallowing.
• Swelling of the arms, hands, feet, ankles, or lower legs.

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