Pradaxa use may increase the risk for potentially fatal internal bleeding, including cerebral hemorrhaging and uncontrollable bleeding from ulcers, as well as heart attack.
Breaking News: Pradaxa’s manufacturer declined to share with regulators a study linking the blood-thinner to a higher rate of fatal bleeding than previously believed, Bloomberg reported in February 2014, citing recently unsealed court filings.
Pradaxa tied for first place as the drug most linked to adverse event reports filed with the FDA in 2011. This shows it ranks among the highest risk of all drug treatments, reported QuarterWatch, a non-profit drug monitoring organization. The FDA received reports of 3,781 serious, harmful events in 2011, as well as 542 deaths in the U.S. alone. Among the reports of hemorrhage, acute renal (kidney) failure and stroke, Pradaxa surpassed all other drugs.
Pradaxa: History of Danger
- May 2012: The European Medicines Agency acknowledges fatal bleedings with Pradaxa and encourages clearer guidance for usage.
- January 2012: Pradaxa use is linked to a 33 percent increased risk of heart attack, according to a study published in the Archives of Internal Medicine.
- December 2011: The Food and Drug Administration (FDA) issues a safety announcement regarding the bleeding incidents reported for patients taking Pradaxa. The FDA notes such bleeding risks are serious and have proven deadly.
Approved by the FDA in October 2010 to prevent strokes in patients with atrial fibrillation, Pradaxa was the first blood thinner to compete with the longtime treatment of warfarin (brand names Coumadin and Jantoven). Just over a year later, research began to emerge, linking Pradaxa to serious bleeding risks that were not communicated to patients.
Many believe that manufacturer Boehringer Ingelheim GmbH rushed Pradaxa through clinical trials and the FDA approval process in order to beat two similar drugs to the market, thereby capturing as many consumers as possible. Unfortunately, this ploy worked, and in April, Pradaxa became a “blockbuster” drug, meaning it generated annual sales of $1 billion or more. Negligence on the part of Boehringer means this dangerous drug has reached millions of patients, potentially caused thousands of injuries and hundreds of deaths.
Your Pradaxa Lawsuit Attorney
Michael Brady Lynch, the founder of The Michael Brady Lynch Firm, was a member of the Plaintiff’s Steering Committee in the Pradaxa Multi-District Litigation and instrumental in securing a $650 million settlement for those injured by Pradaxa uncontrollable bleeding. Mr. Lynch continues to be a leader in Pradaxa litigation nationwide in representing those who continue to suffer uncontrollable bleeding events from Pradaxa.
Attorney Lynch has said, “The U.S. numbers for Pradaxa bleeding events are truly staggering. It is on the verge of a national health disaster.”
Deaths Attributed to Pradaxa Use
As of November 2011, the European Medicines Agency had noted 256 cases of serious bleeding that resulted in the deaths of Pradaxa users. Those are the reported deaths; more patients could have already perished from Pradaxa-related injuries. Additional deaths are likely to occur as Pradaxa remains available in the U.S. market.
Uncontrollable bleeding risk can turn deadly in a variety of ways, including:
- Cerebral (brain) hemorrhaging
- Unstoppable internal bleeding of ulcers
- Vehicle accidents resulting in injury
- Mistakes during operations
If you have experienced internal bleeding / hemorrhaging or have lost a loved one after Pradaxa use, you may be eligible for compensation to offset your financial, physical and emotional burdens. Contact us today to set up a free consultation during which we will listen to your story and discuss your legal rights and options. If you choose us to represent you, we will work with you on a contingency fee basis; this means you pay nothing until we have secured compensation for you, either through a jury verdict or settlement.