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Pradaxa Information

What is Pradaxa?

Pradaxa® is the name under which Boehringer Ingelheim Pharmaceuticals, Inc. markets a prescription anticoagulant medication generically called dabigatran.  

Pradaxa is a blood-thinning drug used to reduce the risk of ischemic stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem.  Since coming on the market in October 2010 the FDA has received numerous Adverse Event Reports involving the following Pradaxa side effects:

  • Serious bleeding side effects such as gastrointestinal (GI) bleeds and rectal bleeding
  • Irreversible life-threatening bleeding events
  • Trauma-induced atypical bleeding incidents due to lack of effective reversal agent
  • Hemorrhages such as brain hemorrhage, intracranial hemorrhage, and hemorrhagic stroke
  • Thromboembolic complications such as cerebrovascular accident (CVA)
  • Death as a result of excessive bleeding

Symptoms of these major bleeding complications include:

  • Coughing up blood
  • Severe bleeding
  • Vomiting blood

We point out that these two important facts:

  1. Pradaxa is associated with an increase in the rate of major gastrointestinal (GI) bleeding despite the lower rates of bleeding at other sites; and,
  2. A trend of higher bleeding risk was seen with advancing age.

In addition, some medical studies have associated Pradaxa with an increased risk of:

  • Heart attack
  • Myocardial infarction (MI)
  • Acute coronary syndrome (ACS)
  • Cardiac bleeds

We are handling personal injury and wrongful death Pradaxa lawsuits involving these serious side effects.

If you need more information or have a possible case, feel free to contact us: 800-426-9535.



All content by attorney Tom Lamb


 

Recent Pradaxa Case Evaluations

Pradaxa - Gastrointestinal (GI) Bleed - 74 yr old man (7956)

Pradaxa - Gastrointestinal (GI) Bleed; Massive Bleeding - Death - 24 yr old man (7488)

Pradaxa - Intracranial Hemorrhage - Death - 86 yr old man (7348)

Pradaxa - Serious Bleeding - 62 yr old woman (7136)

Pradaxa - Serious Bleeding within the Pericardium (sack that surrounds heart) and Abdomen - 89 yr old woman (7119)

Pradaxa - Serious Bleeding within the Pericardium (sack that surrounds heart) - 75 yr old man (7097)

Pradaxa - Serious Bleeding Event - 85 yr old woman - almost fatal occurence; in hospital for 2 weeks, followed by 7 weeks in nursing facility (7038)

 


 

Free Pradaxa Case Evaluation

The information you provide to us for this Free Case Evaluation will be treated as strictly confidential.  You will get a reply from us no later than the next business day.  Submitting a case evaluation does not obligate you to hire our law firm for your lawsuit.  We handle all cases on a contingency fee basis, which means that you will make no payment for our legal services until after we have succeeded in getting legal compensation for you.

 


 

Pradaxa Class Actions vs. Individual Lawsuits

We believe that people who suffered a serious injury or death due to their use of Pradaxa capsules are better served when an individual lawsuit is filed on their behalf. A serious injury or death case should not be filed as part of any Pradaxa class actions together with the claims of many other people who may have had different injuries caused by these birth control pills.

 

Legal Compensation for Pradaxa Side Effects

If you experienced serious side effects from the use of Pradaxa, or a person died due to an adverse reaction while taking Pradaxa, you may have a claim for legal compensation. Such claims involving a serious injury or death caused by the use of Pradaxa are made by filing a lawsuit in court. All states have statutes of limitations that determine the deadlines by which to file lawsuits involving Pradaxa side effects.


 

Pradaxa Medical Information

 

Pradaxa label change: This January 17, 2012 FDA approval letter shows the revisions being made to current Pradaxa Prescribing Information -- also referred to as the package insert or the label. 

 

The "FDA Drug Safety Communication: Safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa (dabigatran etexilate mesylate)" issued December 7, 2011 by the FDA about their current evaluation concerning the safety of Pradaxa.

 

The so-called "Dear Doctor" letter sent to healthcare professionals in the United Kingdom (UK) on October 27, 2011 to inform them of new recommendations to assess renal function:

Direct Healthcare Professional Communication on the importance of assessing renal function in patients treated with ▼Pradaxa® (dabigatran etexilate).


 

Drug Injury Watch: Pradaxa News and Commentary

FDA Drug Safety Concerns About Pradaxa And Serious Bleeding Side Effects Will Get Another Look By Means Of New 2014 Study


A Primary Focus Is Gastrointestinal And Intracranial Hemorrhages In Patients Using Pradaxa For Atrial Fibrillation

SUMMARY: On December 30, 2013 the FDA posted for public comment on a proposed protocol of a new study intended to be a one-time assessment of selected safety outcomes in adults with atrial fibrillation who are new users of Pradaxa (dabigatran) or Coumadin (warfarin).

Some background information about this Pradaxa FDA study of can be found in a January 3, 2014 Forbes article by Larry Husten, "FDA Plans New Safety Assessment Of Dabigatran (Pradaxa)".

We will be watching the FDA and the medical news reports for future developments concerning this latest FDA safety review regarding Pradaxa and serious bleeding side effects, some of which can result in death.

[Read this article in full at original source]

 

Earlier Pradaxa articles by Tom Lamb on the Drug Injury Watch blog:

The Pradaxa Gastrointestinal (GI) Bleeding Debate Continues: Is There An Increased Risk Or A Risk Reduction With Pradaxa Use?

Pradaxa Adverse Drug Events (ADEs) Result In Death More Often Than Other Anticoagululants / Blood Thinners ADE Reports

Pradaxa: February 2013 Update: Federal Court MDL Litigation Now Involves About 200 Lawsuits

December 2012 Pradaxa Label Change: Contraindication: Use By Mechanical Heart Valves Patients

December 2012 Pradaxa Update: Prescription / Sales Numbers And Drug Company Safety Study Results

Pradaxa Safety Debate Continues During November 2012 With Many Different Conclusions And Positions

Fall 2012: Two Recent Medical Reports Regarding Safety Of Pradaxa, Boehringer Ingelheim's Anticoagulation Drug

Increasing Number Of Pradaxa Lawsuits Against Boehringer Are Consolidated In Federal Court MDL

Pradaxa Side Effects Update Mid-2012: Deaths, Hemorrhages, Acute Renal Failure, and Stroke Events Submitted To FDA MedWatch

Safety Developments Regarding Pradaxa: Boehringer Starts Drug Registry; EMA Wants Label Change; Study Compares Pradaxa Use To Coumadin As Regards Side Effects

Pradaxa Noted For Possible Heart Attack Risk In Addition To Serious Gastrointestinal Bleeding And Other Hemorrhages

Pradaxa Hemorrhage Cases May Occur In Oldest Patients Due To Age-Related Decline In Renal Function

Pradaxa: 2012 Label Revisions In The U.S. And Canada, Where A "Dear Doctor" Letter Was Sent Out


Pradaxa Bleeding Events: Four Major Factors Which Contributed To These Serious Side Effects

Pradaxa: Excess Number Of Severe Bleeding Events In Certain Patient Populations And Settings


Safety Profile Of New Stroke Drug Pradaxa Has Been Tarnished By Various Adverse Event Reports
  


Pradaxa: FDA Investigating Possible Higher Than Expected Incident Rate Of Serious Bleeding Side Effects
  


New Heart Drug Pradaxa May Be Sending "Early" Drug Safety Signals


All content by attorney Tom Lamb


  • US FDA advises that you should not stop taking any prescription medication before talking to your doctor.
  • Reports of serious drug side effects should be made to the US FDA MedWatch program.
  • The prescription drug names are registered trademarks of the respective drug companies.
  • DrugInjuryLaw.com is not affiliated with any of the drug companies, nor US FDA.