Pradaxa & Internal Bleeding

The maker of Pradaxa has settled more than 4,000 cases linking the drug to internal bleeding.

In Short:
  • Pradaxa is still on the market and has not been recalled.
  • Internal bleeding and brain hemorrhaging risks have been identified.
  • Attorneys have settled cases for around 4,000 people.
internal bleeding pradaxa
Side Effects Of Pradaxa

Pradaxa patients that have suffered from internal bleeding or brain hemorrhaging while using the drug may be eligible for compensation.

The most common side effect is gastrointestinal internal bleeding.

pradaxa settlement
$650 Million Settlement

4,000 cases have been settled for $650 million total. Additional settlement information is unavailable at this time.

We are awaiting information from the manufacturer on a potential future injury fund to compensate those not included in the recent settlement.

side effects of pradaxa
Latest News

The latest settlement information is available in our Pradaxa news section. We will post updates as additional information becomes available.

If you have additional questions, please contact a patient advocate via our live chat system.

Pradaxa is the brand name for dabigatran, a blood thinner prescribed to patients with atrial fibrillation.

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Blood Thinner: Pradaxa

The drug is designed to prevent blood clots, stroke, and pulmonary embolism. Pradaxa was approved by the FDA in 2010, and is sold by the German drug company Boehringer Ingelheim.            

Pradaxa has been linked with serious health risks, such as irreversible internal bleeding, heart attack, and even death.            

In 2014, Boehringer Ingelheim, the maker of Pradaxa, paid approximately $650 million to settle around 4,000 lawsuits alleging the drug caused internal bleeding, brain hemorrhaging or death.            

Unfortunately, this settlement only covered cases filed prior to May of 2014.

Pradaxa Side Effects

Common side effects include:

  • Chest pain or tightness
  • Difficulty breathing or wheezing
  • Bleeding in the intestines
  • Dizziness
  • Indigestion or abdominal pain
  • Bleeding in the kidneys
  • Swelling of face or tongue
  • Bleeding in the brain (brain hemorrhage)
  • Heart attacks.

The drug was approved by the FDA in 2010. According to the FDA database, by 2012, over 17,000 people reported adverse side effects from using Pradaxa. In addition, 6,249 hospitalizations and 1,847 patient deaths were determined to be caused by Pradaxa use.

Free Case Review

Medical Risk

Pradaxa's manufacturer, Boehringer Ingelheim, faces liability for losses and damages to its consumers because it did not warn patients of these risks. Furthermore, the drug maker has a history of negligence.

38,527
Serious FDA Cases
8,272
FDA Death Cases
52,521
Total FDA Cases

Boehringer Ingelheim produces a large number of medications to treat abdominal pain, bladder disorders, COPD (chronic obstructive pulmonary disease), respiratory disease, acid reflux, ulcers, cardiovascular disease, Parkinson's disease, HIV, and thromboembolic disease. The company’s more widely known products include Pradaxa, Zantac, Spiriva, Flomax, Dulcolax, and Metacam.

The FDA has issued multiple serious safety violations against this company.

In 2011, the FDA shut down a drug manufacturing plant that was a Boehringer Ingelheim subsidiary. Inspectors noted that the Ohio facility contained mold, rusty tools, and a barrel of urine. The company then spent $300 million to appropriately upgrade the plant.

Most recently, Boehringer’s blockbuster drug Pradaxa has been the center of controversy. Pradaxa is linked to thousands of injuries and hundreds of deaths from uncontrollable internal bleeding.

Within weeks of the FDA’s approval of Pradaxa, further research by MedWatch showed the agency had received more reports of side effects from Pradaxa than 98 percent of any of the other drugs on the market. Complaints included internal bleeding in the brain, intestines, and kidneys, as well as heart attacks.

On December 7, 2011, the FDA launched an investigation into Pradaxa following reports of 3,781 side effects and 542 deaths, the highest number of cases reported for any drug that year.

Pradaxa Safety Warnings

Experts still disagree about whether Pradaxa has higher risks for internal bleeding. The FDA has advised that the drug is as safe as the more common prescribed the blood thinner Warfarin.

However, the Institute for Safe Medication Practices has named Pradaxa one of the most dangerous drugs on the market and warned that patients suffering from internal bleeding after taking Pradaxa are nearly five times more likely to die from this condition than those with internal bleeding after taking Coumadin or Warfarin.

FDA Hemorrhage Reports

Rectal Hemorrhage
1,671
reports
General Hemorrhage
2,537
reports
Cerebralvascular Hemorrhage
2,906
reports
GI Hemorrhage
7,214
reports

Research & Studies

Additionally, a study from the University of Illinois at Chicago has suggested that the FDA's data may be flawed, and the risk for bleeding may be higher than the agency thought. Most recently, researchers in Denmark discovered that patients may be using Pradaxa improperly, and there may be higher risks of internal bleeding when switching from other blood thinners.

While all blood thinners can cause internal bleeding, most, like Coumadin or Warfarin, have "reversal agents" that can be used in the case of emergency. Doctors have reported that once Pradaxa causes bleeding, there is little they can do to stop it.

Legal Assistance

In 2018, several trials began in the latest round of Pradaxa lawsuits, with juries awarding over $1 million to victims of internal bleeding. Lawyers are still helping those affected file claims.

Pradaxa Recall

Pradaxa has been prescribed to millions of patients in more than 70 countries. Soon after FDA approval, however, reports of serious health risks emerged, including uncontrolled internal bleeding.

Pradaxa has been linked to these serious conditions:

  • Bleeding in the brain (brain hemorrhage)
  • Bleeding in the intestines
  • Bleeding in the kidneys
  • Heart attack.

At this time, there is no official Pradaxa recall. However, a federal judge recently ruled that those affected by the drug's side effects, or family members who have lost a loved one, can proceed with lawsuits.

Sources of information

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