Pradaxa (dabigatran) is a blood-thinning medication intended to prevent strokes and heart attacks in people with irregular heart rhythm. Unfortunately, there is growing evidence linking Pradaxa to severe, uncontrollable bleeding.
Need a Texas Pradaxa Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured by severe bleeding, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
UPDATE: FDA Approves Praxbind – Reversal Agent to Pradaxa
November 18, 2014 — Combining common painkillers with blood-thinning drugs could significantly increase the risk of bleeding and blood clots for people with atrial fibrillation. Click here to read more.
November 7, 2014 — Two studies have linked Pradaxa with higher gastrointestinal bleeding risks than warfarin — one study found a 28% increased risk, and the other (after compensating for patient risk-factors) linked Pradaxa to an 85% increased risk of gastrointestinal bleeding. Click here to read more.
November 5, 2014 — In sharp contrast to the RE-LY trial, JAMA Internal Medicine has published a massive study linking Pradaxa to significantly higher rates of bleeding, including a 60% increased risk of major bleeding compared to warfarin. Click here to read more.
July 23, 2014 — Boehringer Ingelheim knew that blood tests and routine monitoring could improve the safety of Pradaxa, but failed to share those findings with health officials, according to a series of reports published in the British Medical Journal. Click here to read more.
May 28, 2014 — Boehringer Ingelheim announced they will pay $650 million to settle up to 4,000 lawsuits involving Pradaxa. Click here to read more.
May 27, 2014 — According to Bloomberg, Boehringer Ingelheim has admitted that 22 cases of serious bleeding were not included in the RE-LY clinical trial, the pivotal safety study that compared Pradaxa to warfarin. The FDA used results of the 18,000-patient study to approve Pradaxa in 2010. Click here to read more.
May 13, 2014 — Pradaxa is associated with a 28% higher rate of gastrointestinal bleeding than warfarin, but lower rates of stroke and death, and similar rates of heart attack, according to a Safety Communication published by the FDA. Click here to read more.
April 7, 2014 — Pradaxa has been approved for treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral blood-thinner for 5-10 days. Click here to read more.
February 26, 2014 — Boehringer Ingelheim concealed a data analysis linking Pradaxa to more fatal bleeding events than another study that was used to win the drug’s approval. Click here to read more.
February 11, 2014 — Controversial conclusions of study indicate that some patients may actually benefit from blood testing on Pradaxa. Click here to read more.
January 14, 2014 — The FDA is launching a new study to compare the bleeding risks of Pradaxa vs. warfarin. Click here to read more.
September 9, 2013 — A study of Pradaxa in mechanical heart-valve patients had to be halted after researchers linked Pradaxa to an increased risk of bleeding and other life-threatening complications. Click here to read more.
July 24, 2013 — Two new studies have found that the risk of heart attacks is higher for Pradaxa than similar blood-thinning drugs, and the risk increases with higher doses of Pradaxa. Click here to read more.
February 1, 2013 — QuarterWatch report links Pradaxa to a 5-fold increased risk of hemorrhagic death compared to Coumadin (warfarin) — 19% versus 4% — based on adverse event data submitted to the FDA MedWatch system. Click here to read more.
December 20, 2012 — The FDA has published a Safety Communication to warn about an increased risk of heart attack, stroke, blood clots, and major bleeding in heart valve patients who are given Pradaxa. A study had to be halted early after researchers found a significant increase in these life-threatening events. Click here to read more.
November 9, 2012 — Study finds comparable rates of bleeding among new users of Pradaxa or warfarin, critics call the study methodology “flawed.” Click here to learn more.
September 28, 2012 — A new study has found that Pradaxa bleeding risks offset any health benefit compared to a placebo. The study found no improvement in survival rates. Click here to read more.
September 6, 2012 — Despite the risks associated with Pradaxa, researchers have found a dramatic increase in “off-label” use of the drug. Click here to read more.
September 5, 2012 — Judge David Herndon, who presides over the Pradaxa MDL, said he wants the litigation to move forward as expeditiously as possible. There are already 72 Pradaxa lawsuits involving 82 plaintiffs in the MDL. Click here to read more.
August 8, 2012 — Nationwide Pradaxa lawsuits have been consolidated into a federal Multi-district Litigation (MDL). Unlike a class action, lawsuits remain individual in an MDL. As more Pradaxa lawsuits are filed, they will be transferred to the U.S. District Court for the Southern District of Illinois before Judge David Herndon. Click here to read more.
What is Pradaxa and how does it work?
Pradaxa (dabigatran) is a blood-thinning medicine prescribed to prevent blood clots, strokes, heart attacks that are caused by abnormal heart rhythm (atrial fibrillation). It was developed by Boehringer Ingelheim and approved by the U.S. Food and Drug Administration (FDA) in 2010.
People with atrial fibrillation often experience blood clots because the heart does not beat correctly. Blood clots can be deadly if they travel through the blood stream and become lodged in a major organ. Pradaxa prevents blood clots by inhibiting the blood enzyme thrombin, which prevents blood platelets from sticking together and forming clots. It belongs to a class of blood-thinners called “direct thrombin inhibitors.”
What is the problem with Pradaxa?
Pradaxa has been associated with more than 500 deaths due to internal bleeding, heart attacks, and other complications. Another serious problem is that Pradaxa has no quick reversal mechanism (unlike warfarin, which can be reversed with a dose of Vitamin K). If a person who is using Pradaxa is injured or requires emergency surgery, the physician must order dialysis to mechanically remove Pradaxa from the bloodstream. This can take 2-3 hours, which may be too late.
The RE-LY Clinical Trial
The “Randomized Evaluation of Long-term Anti-Coagulation Therapy” (RE-LY) clinical trial compared the efficacy of Pradaxa and warfarin. Each medication was administered in a blinded manner to patients had atrial fibrillation. These patients were at increased risk for stroke associated with systemic embolisms (blood clots).
Findings of the RE-LY Clinical Trial and Bleeding:
- 16.4% of people taking Pradaxa experience bleeding
- 17.4% of people taking Pradaxa who needed emergency surgery experienced major bleeding
- 3.3% of users experience serious bleeding
- 1.5% experience life-threatening bleeding
- 0.3% experience bleeding in the brain (cerebral hemorrhage)
Pradaxa Side Effects
- Heart attack
- Internal bleeding
- Gastrointestinal bleeding
- Cerebral hemorrhage (bleeding in the brain)
Need a Pradaxa Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Pradaxa lawyers for a free lawsuit review.