Pradaxa Bleeding and Pradaxa Lawsuits
The Law Firm of Eric H. Weinberg is currently investigating cases on behalf of individuals who may have suffered serious or life threatening complications, including internal bleeding, after taking Pradaxa. We are ready to help you. If you or a loved one has experienced a Pradaxa side effect and you have a question regarding your legal rights, please submit the easy to use “Pradaxa Lawsuit Evaluation Form” found on this page, or call us 24/7 toll free at 1-877-934-6274. We promise to bring our more than 20 years of experience litigating pharmaceutical cases to bear in your Pradaxa lawsuit.
Why Pradaxa is Prescribed
Pradaxa (dabigatran etexilate mesylate) prevents the formation of blood clots and is prescribed to reduce the risk of stroke in patients with non-valvular atrial fibrillation. Pradaxa is manufactured by Boehringer Ingelheim, whose U.S. headquarters are located in Ridgefield, CT.
FDA Evaluates Pradaxa Serious Bleeding Events and Pradaxa Related Deaths
In its December 7, 2011, Safety Communication the U.S. Food and Drug Administration, FDA, stated that it is currently evaluating post-marketing reports of serious bleeding events, including deaths, in patients taking Pradaxa. While internal bleeding is a known complication of blood thinning therapies, the FDA will determine if bleeding complications occur more commonly with Pradaxa than would be expected.
Due to the risk of stroke, the FDA cautioned that patients should not stop taking Pradaxa without talking to their healthcare professional first. The FDA also advised that patients should call their healthcare professional and seek immediate medical care if they develop any signs or symptoms of bleeding such as:
- Unusual bleeding from the gums
- Nose bleeding that happens often
- Menstrual or vaginal bleeding that is heavier than normal
- Bleeding that is severe or that you cannot control
- Pink or brown urine
- Red or black stools (looks like tar)
- Bruises that happen without a known cause or that get larger
- Coughing up blood or blood clots
- Vomiting blood or vomit that looks like coffee grounds
Pradaxa is also being monitored for an increased risk of serious or fatal bleeding by drug regulatory agencies worldwide. The European Medicines Agency reported that as of November 6, 2011, a worldwide total of 256 spontaneous case reports of serious bleeding resulting in death were reported in association with Pradaxa therapy.
Pradaxa Label Changes – Bleeding Risks and Irreversible Bleeding
In January of 2012 the FDA reported that it had approved revised product labeling for Pradaxa. The labeling changes, which focused primarily on safety, reflect that at this time, there is no specific agent or medication that will reverse a Pradaxa bleed. Instead, the patient’s body must naturally eliminate Pradaxa by way of the renal (kidneys) system. In addition, the revised label reflects that Pradaxa’s anticoagulant (anti-clotting) activity and half-life are increased in patients with kidney impairment.
What You Should Do If You Suspect a Pradaxa Bleeding Complication or Pradaxa Side Effect
If you believe that you or someone close to you is experiencing a Pradaxa side effect, contact your medical professional for an evaluation. Consumers and professionals can report suspected Pradaxa side effects, including MI, heart attack, or bleeding complications to the FDA’s MedWatch Adverse Event Reporting Program at www.fda.gov/MedWatch/report.htm, or by phone at 800-FDA-1088.
Obtain a Free Pradaxa Lawsuit Evaluation
If you or a loved one has taken Pradaxa and has experienced serious bleeding or other life threatening complications, please contact The Law Firm of Eric H. Weinberg for a free and non-obligatory Pradaxa lawsuit consultation at 1-877-934-6274. You can contact our firm online by submitting the easy-to-use “Free Legal Case Evaluation Form” found on this page.
The Law Firm of Eric H. Weinberg has represented hundreds of individuals and thousands more class action claimants injured by the side effects of well known prescription drugs including Vioxx, Ortho Evra, Baycol, and blood clotting products.
