FDA: Blood Thinner, Pradaxa, Should Not Be Used by Patients with Mechanical Prosthetic Heart Valves

Blood thinner, Pradaxa (dabigatran etexilate mesylate), should not be used to prevent stroke or blood clots in patients implanted with mechanical heart valves.

The U.S. Food and Drug Administration (FDA) has recently informed health care professionals and the public of the dangers of Pradaxa for patients with mechanical heart valves. A clinical trial in Europe was halted because Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the heart devices than were users of warfarin, another anticoagulant medication. Pradaxa users also experienced more bleeding after valve surgery than those taking warfarin.

Pradaxa is a blood-thinning medication used to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation (AF), a common heart rhythm abnormality. The drug, however, is not approved for patients with atrial fibrillation caused by heart valve problems.

The FDA recommends that health care professionals transition any patient with a mechanical heart valve who is taking Pradaxa to another medication. Note: the use of Pradaxa in patients with valve replacements made of natural biological tissue has not been evaluated.

The FDA warns that patients should not stop taking anticoagulant medication without consulting their health care professionals. Suddenly stopping Pradaxa or other anticoagulants may increase the risk of blood clots and stroke.

Patients and health care professionals are encouraged to report adverse events or side effects related to Pradaxa use to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. Reports can be submitted online: www.fda.gov/MedWatch/report.htm. Download the report form at this site or call, toll-free, 1.800.332.1088 to request a copy of the pre-addressed form, which may be mailed to FDA or submitted by fax to 1.800.FDA.0178.

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