This new contraindication is just another reminder that Pradaxa side effects, including internal bleeding, can be quite serious.
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 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 available antidote. The FDA received reports of 542 deaths and 3,781 side-effect incidents tied to the drug in 2011. Bloomberg also reported that the Institute of Safe Medication Practices has found Pradaxa has generated more reports of injury or death than any of the 800 drugs it monitors.
According to Bloomberg, 150 Pradaxa lawsuits are now pending in a federal multidistrict litigation currently underway in U.S. District Court, Southern District of Illinois. All of the complaints allege plaintiffs suffered serious, life-threatening episodes of internal bleeding, and that the company sold the blood thinner despite knowing it could cause fatal bleeding in some patients. (In Re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation – MDL No. 2385)
Victims of serious Pradaxa side effects may be eligible to collect compensation for their medical bills, lost wages, pain and suffering and more. To learn more about filing a Pradaxa lawsuit, please visit our website http://www.consumerinjurylawyers.com/, or call 1-877-779-1414 to speak with one of our attorneys today.
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. The firm has been named by The National Law Journal to the “Plaintiffs’ Hot List,” recognizing the top plaintiffs’ firms in the country, for the past 10 consecutive years.
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