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Pradaxa Side Effect Warning: Pradaxa Label to Warn Blood-Thinner Shouldn’t be Used in People with Mechanical Heart Valves, Bernstein Liebhard LLP Reports
Date:12/22/2012

New York, NY (PRWEB) December 22, 2012

A new Pradaxa side effect warning has been announced by Boehringer Ingelheim, the maker of the blood thinner, Bernstein Liebhard LLP reports. According to an alert issued by U.S. Food & Drug Administration (FDA) on December 19th, the company will be modifying the Pradaxa label to warn that it should not be prescribed to patients who have had a mechanical prosthetic heart valve replacement. Boehringer Ingelheim will also be sending a “Dear Doctor Letter” to healthcare providers to inform them of this new contraindication. The change follows the halt of RE-ALIGN trial, which was ended because Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than were users of warfarin. There was also more bleeding after valve surgery in the Pradaxa users than in the warfarin users, the FDA said.

“This new contraindication is just another reminder that Pradaxa side effects, including internal bleeding, can be quite serious,” says Bernstein Liebhard LLP, a national law firm representing clients who have been injured by dangerous drugs and defective medical devices. The firm is currently offering free and confidential Pradaxa lawsuit evaluations to patients who were allegedly harmed by this drug.

Pradaxa Lawsuits
Pradaxa is used to prevent strokes in people with a heart-rhythm disorder known as atrial fibrillation. According to a recent report from Bloomberg.com, internal bleeding is a potential Pradaxa side effect for which there is no readily
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