Pradaxa Heart Attack and Death

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Members of our team are currently investigating cases on behalf of individuals who may have suffered life threatening complications, including internal bleeding, heart attack (MI / myocardial infarction) or death, 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 1-800-632-1404. To learn more about Pradaxa, please continue reading.

What is Pradaxa?

Manufactured by Boehringer Ingelheim , Pradaxa is an anticoagulant, or blood thinner, medication prescribed to help prevent stroke by preventing the formation of blood clots. The FDA is investigating the safety of Pradaxa following reports that the drug may lead to excessive bleeding that could result in severe and even life-threatening injury.

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. The FDA’s safety announcement in December 2011 followed a November 2011 warning issued by the European Medicines Agency (EMA). The EMA reported more than 250 cases of serious and even fatal bleeding complications associated with Pradaxa.

The FDA communication states that potential serious or even fatal bleeding is a known complication of all blood-thinning drugs, but the organization is working with Boehringer Ingelheim to review the post-market reports of excessive bleeding to determine whether they are higher than should be expected based on results from the clinical trial that supported the drug’s 2010 approval.  The FDA also advises that “Patients with AF should not stop taking Pradaxa without talking to their healthcare professional. Stopping use of blood thinning medications can increase their risk of stroke. Strokes can lead to permanent disability and death.”

Read the FDA Pradaxa Safety Announcement.

Possible Signs of a Problem

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 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 atwww.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 including a heart attack or MI or even death, please contact our team of lawyers for a non-obligatory Pradaxa lawsuit consultation.

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