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Patients who have artificial heart valves should not take Pradaxa (dabigatran etexilate mesylate). Pradaxa is an anticoagulant drug that many hoped would replace Coumadin. Unfortunately, compared to Coumadin, it is more dangerous and deadly. This week, the FDA issued another Pradaxa warning, this time for patients with artificial heart valves. According to Beth Carr,of the U.S. Public Health Service, a European clinical trial of Pradaxa had to be cancelled early, because patients were experiencing serious health issues while taking the drug.

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The FDA warns that Pradaxa should not be used to prevent stroke or blood clots in patients with artificial heart valves due to an increased risk of stroke, heart attack and death. In addition, patients who take Pradaxa are more likely to have bleeding injuries after surgery. The FDA has now officially made Pradaxa “contraindicated” for patients with mechanical heart valves.

Any doctor who has patients on Pradaxa with a mechanical heart valve should immediately begin transitioning them to a safer medication. If you are a patient with a mechanical heart valve and take Pradaxa, contact your doctor immediately. Do not hesitate. If you cannot reach your physician contact your nearest emergency room and advise them that you are on a medication that the FDA has just found to cause heart attacks and strokes. It is important to not suddenly stop taking Pradaxa, or any anticoagulant medication, without medical supervision.

For additional information on Pradaxa and its new contraindications, you can listen to Ms. Carr’s FDA Podcast here. If you have experienced an adverse reaction to Pradaxa or any other medication, it is important to advise your physician and the FDA.

We are currently investigating cases for people across the country, who have had a heart attack, stroke or bleeding event while taking Pradaxa. If you have taken Pradaxa, you may be entitled to make a claim. Please contact our Pradaxa law office for a free consultation regarding your legal rights.