FDA Issues Warning about Pradaxa Use with Mechanical Heart Valves
The FDA has issued a safety warning to health care professionals and patients regarding the use of Pradaxa (dabigatran etexilate mesylate) in individuals who have mechanical heart valves. Pradaxa is blood thinning drug used to reduce the risks of blood clots and stroke for patients with atrial fibrillation, or irregular heartbeat. Information gathered during a recent clinical trial indicated that patients with mechanical heart valves, who took Pradaxa, were more likely to suffer strokes, heart attacks, and have blood clots form on their prosthetic heart valves. There was no data regarding patients who have bioprosthetic valves, or valves made of living tissue.
This safety warning instructs health care professionals to transition patients with mechanical heart valves who are taking Pradaxa to other medications. Patients who are currently taking Pradaxa and have had a heart valve replacement should consult their physicians before they stop taking the drug.
If you or a loved one has taken Pradaxa and have suffered an injury as a result, contact us to talk with one of our experienced product liability/personal injury attorneys to discuss your legal options.