New FDA Pradaxa Warning - Consumer Justice Foundation

New FDA Pradaxa Warning

Written by Faith Anderson on December 20, 2012
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Potential Side Effects of Pradaxa Use

Pradaxa is a blood thinner, also known as an anticoagulant, that is commonly prescribed to reduce the risk of stroke and blood clots in patients with a medical condition called non-valvular atrial fibrillation (AF). Atrial fibrillation is a common heart rhythm abnormality that causes the upper chambers of the heart, or atria, to beat irregularly and rapidly. Pradaxa, however, is not FDA-approved for use in patients with atrial fibrillation caused by heart valve problems, and in light of the results of the European clinical trial, the FDA is warning against the use of Pradaxa in patients with mechanical heart valves. According to the agency, doctors should promptly transition any Pradaxa patient with a mechanical prosthetic heart valve to another medication. The FDA also warned that “The use of Pradaxa in patients with another type of valve replacement made of natural biological tissue, known as bioprosthetic valves, has not been evaluated and cannot be recommended.”

Contact an Experienced Attorney to File a Claim

In response to the risk of adverse events in patients with mechanical heart valves using Pradaxa, the FDA has recommended that Pradaxa patients with all types of prosthetic heart valve replacements consult their healthcare provider as soon as possible to determine the most appropriate blood thinner treatment. In addition to an increased risk of stroke, heart attack and blood clots in Pradaxa patients, mounting research has identified Pradaxa use as a risk factor for severe and potentially life-threatening internal bleeding. In fact, the FDA previously issued a Drug Safety Communication regarding the risk of serious bleeding associated with the use of Pradaxa in patients with non-valvular AF, the specific population for which the anticoagulant drug has been approved. If you or a loved one has taken Pradaxa and has since suffered a major side effect, you may be entitled to compensation for your injuries. Our consumer advocates at the Consumer Justice Foundation can put you in contact with a reputable lawyer in your area, with whom you can discuss your legal options.

Posted Under: FDA - Food and Drug Administration
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