Pradaxa

Pradaxa, a new-generation blood thinner marketed by Boehringer Ingelheim, was touted as an improvement over warfarin when it was approved by the U.S. Food & Drug Administration (FDA) in October 2010. However, for several years there was no antidote available to reverse internal bleeding that can sometimes occur with its use.

Pradaxa Lawsuit Reviews

Bernstein Liebhard LLP is offering free legal reviews to individuals who may have experienced episodes of uncontrollable bleeding and related complications due to Pradaxa. To learn more about your legal rights, please contact our Firm by calling (888) 994-5118 to schedule a free, no-obligation case review.

What is Pradaxa?

pradaxa blood thinnerPradaxa (dabigatran) belongs to a new class of blood thinners called direct thrombin inhibitors. These drugs work by blocking the action of thrombin, an enzyme involved in blood clotting. Pradaxa was initially approved to prevent strokes in patient suffering from atrial fibrillation, a heart rhythm disorder. It has since been cleared to treat deep vein thrombosis and pulmonary embolism, and to prevent these dangerous blood clots in patients undergoing hip and knee implant surgery.

Once the drug came to market, Boehringer Ingelheim promoted Pradaxa by highlighting its purported superiority to warfarin. Among other things, the company’s marketing materials pointed out that Pradaxa patients did not need to endure the same dietary restrictions or regular blood monitoring experienced by those using warfarin. In 2011 alone, Boehringer Ingelheim had spent $464 million to market Pradaxa. By the first quarter of 2012, worldwide sales reached $209 million.

Pradaxa Side Effects

Patients taking Pradaxa should check with their doctor immediately if they experience:

  • Acid or sour stomach
  • belching
  • black, tarry stools
  • bloody stools
  • constipation
  • diarrhea
  • heartburn
  • indigestion
  • nausea
  • pain or burning in the throat
  • stomach discomfort, upset, burning, or pain
  • vomiting
  • vomiting of blood or material that looks like coffee grounds

Other rare side effects may include:

  • cough
  • difficulty with swallowing
  • dizziness
  • fainting or loss of consciousness
  • fast heartbeat
  • fast or irregular breathing
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness of the skin
  • skin rash, hives, welts, or itching skin
  • tightness in the chest
  • trouble breathing
  • unusual tiredness or weakness

Pradaxa Internal Bleeding

Internal bleeding is one of the most serious complications that may occur with the use of a blood thinner, including Pradaxa. This may include:

  • Brain hemorrhaging
  • Gastrointestinal (GI) bleeding
  • Kidney bleeding

Until recently, there was no way to reverse Pradaxa’s anticoagulant effects should internal bleeding occur. By contrast, bleeding associated with warfarin can be reversed via the administration of vitamin K.

Patients most at risk for a Pradaxa bleeding event include those:

  • Age 75 and over
  • With kidney problems
  • With stomach or intestine bleeding that is recent or recurring due to a stomach ulcer

Symptoms of internal bleeding associated with Pradaxa include:

  • Unusual Bruising or Bleeding
  • Pink or Brown Urine
  • Red or Black Tarry Stool
  • Coughing up Blood (which may include vomiting that resembles coffee grounds)
  • Headaches, Dizziness or Lethargy
  • Bleeding from the Gums
  • Frequent Nose Bleeds
  • Weakness and Swelling of the Arms, Hands, Feet, Ankles or Lower

In October 2015, the FDA granted accelerated approval to Praxbind (idarucizumab) for use in emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.

Pradaxa Settlement

Thousands of people have filed Pradaxa lawsuit after allegedly experiencing episodes of uncontrollable internal bleeding due to their use of the blood thinner. Among other thing, plaintiff accused the drug’s manufacturer of wrongly marketing Pradaxa as an improvement over warfarin. They also alleged that Boehringer Ingelheim had failed to provide proper warnings regarding the lack of an antidote for Pradaxa’s bleeding side effects. In May 2014, Boehringer Ingelheim announced that it had agreed to pay $650 million to settle thousands of Pradaxa bleeding claims pending in courts around the U.S.

  1. FDA (2015) “Medication Guide – Pradaxa” http://www.fda.gov/downloads/Drugs/DrugSafety/UCM231720.pdf
  2. USA Today (2012) “Blood-thinner Pradaxa target of mass-claims suit” http://usatoday30.usatoday.com/news/health/story/2012-08-19/pradaxa-blood-thinner-lawsuit/57134628/1
  3. FDA (2012) “FDA approves Praxbind, the first reversal agent for the anticoagulant Pradaxa” http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm467300.htm
  4. New York Times (2015) “$650 Million to Settle Blood Thinner Lawsuits” http://www.nytimes.com/2014/05/29/business/international/german-drug-company-to-pay-650-million-to-settle-blood-thinner-lawsuits.html?_r=0
Last Modified: January 6, 2016

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