The FDA was informing healthcare professionals and the public about the dangers of Pradaxa for patients with mechanical heart valves. A clinical trial was halted because Pradaxa users were more likely to have strokes, heart attacks, and blood clots.
New York, New York (PRWEB) September 25, 2013
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs, is reporting that the Pradaxa multidistrict litigation (MDL) now under way in U.S. District Court, Southern District of Illinois (In Re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation – MDL No. 2385), is slated to have its next Status Conference on Oct. 8, 2013, according to court documents, which also noted that the court has appointed a mediator for discovery disputes.
“We continue to evaluate cases in which Pradaxa patients suffer from habitual occurrences of severe bleeding, which is allegedly due to ingestion of Pradaxa,” says Parker Waichman LLP, which is currently offering alleged victims of Pradaxa bleeding free legal evaluations.
The U.S. Food and Drug Administration (FDA) approved Pradaxa in August 2010; it is a blood-thinning (anticoagulant) medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), the most common type of heart rhythm abnormality. The drug got a large boost in sales when it reached the market as it was then considered a more effective treatment for preventing strokes than older medications, such as the onetime gold-standard Coumadin, as Bloomberg noted in a Dec. 11, 2012, report. However, Bloomberg added, while warfarin bleeding can be stopped via the administration of vitamin K, there is no antidote for stopping Pradaxa bleeding, making these events potentially far more deadly.
Two years following its debut, Pradaxa and the FDA were both under fire. A study appearing in the Sept. 5, 2012Journal of the American Medical Association noted that the FDA’s expedited drug development process raised questions about whether the FDA truly had the public’s safety in mind when it allowed new drugs on the market.
By Dec. 19, 2012, the FDA was informing healthcare professionals and the public about 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 than were users of warfarin, another anticoagulant medication sold under the brand name Coumadin. Pradaxa users also experienced more bleeding after valve surgery
Bloomberg.com has since reported that the drug has been the subject of several safety alerts in the U.S. and abroad regarding the internal bleeding that can accompany its use. A study published by the Institute for Safe Medicine Practices on Jan. 9, 2013, reported that Pradaxa bleeding is five times more likely to be fatal than warfarin bleeding.
Other studies found additional adverse side effects related to Pradaxa. One study found that the blood thinner may actually increase one’s risks of viral infections, as well as the infection’s severity. University of North Carolina researchers discovered that Pradaxa blocks a critical component in the human blood clotting system – which may increase viral infection risks. Increased risks were seen for the flu and the viral heart infection called myocarditis, which is a significant cause of sudden death in children and young adults, News-Medical.Net reported on April 2, 2013.
Parker Waichman LLP is offering free lawsuit consultations to victims of Pradaxa bleeding side effects. If you or a loved one took Pradaxa and experienced a life-threatening bleeding event, please visit the firm's Pradaxa internal bleeding page at yourlawyer.com. Free case evaluations are also available by calling 1-800-LAW-INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney