FDA Alert: Pradaxa use linked to extreme and potentially fatal bleeding risks

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Those who were prescribed Pradaxa may have experienced the following:

  • Internal bleeding of the
    • Brain (Cerebral Hemorrhaging)
    • Intestines (gastrointestinal bleeding)
    • Kidneys
    • Other organs
  • Hospitalization due to excessive bleeding
  • Heart Attack
  • Other Cardiac Event
  • Symptoms such as: pink or brown urine, red or black tarry stools, coughing up or vomiting blood, bleeding from the gums, bruises without a known cause or frequent nosebleeds

Unfortunately, a death has occurred for some who have taken Pradaxa.

If you, or a loved one, have taken Pradaxa and have experienced any of the above

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Breaking News, August 2012: All Pradaxa cases consolidated into multidistrict litigation (MDL), indicating that Pradaxa litigation is moving forward and courts anticipate many more claims.

The anticoagulant Pradaxa (generic: dabigatran) has been reported to cause injuries such as:

  • Brain Hemorrhaging/Bleeding
  • Gastrointestinal (GI) Bleeding
  • Kidney Bleeding
  • Internal Bleeding
  • Heart Attack/ Cardiac Injury
  • Death

Pradaxa manufacturer confirmed more than 260 deaths worldwide among Pradaxa users. Causes of death from Pradaxa use could occur from:

  • Having a medical condition such as an ulcer that began bleeding and could not be stopped
  • A traffic accident or trauma resulting in unstoppable bleeding
  • Not being able to receive emergency surgery due to risk of uncontrollable bleeding
  • Heart attack (Myocardial infarction)

If you or someone you love has suffered excessive and uncontrollable bleeding, or a heart attack after taking Pradaxa, you deserve compensation. We can help you cope with the resulting physical, financial and emotional hardships.

Hundreds of Deaths Confirmed Among Pradaxa Users - Lawsuits Filed Against Manufacturer

Victims of injury and death related to Pradaxa use filed the first lawsuits against manufacturer Boehringer Ingelheim Pharmaceuticals in March 2012. Suits continue to be filed against the negligent drug maker, alleging that Boehringer "put all patients at an increased risk for developing life-threatening bleeds" because of Pradaxa's "marketing and design defects.

Studies Reveal Pradaxa Dangers

May 2012: A study comparing Pradaxa to warfarin indicate that Pradaxa is linked more frequently to complications, including serious bleeding episodes, deep vein blood clots, skin rash, GI symptoms and even death. Patients in the study were switched to Pradaxa after taking warfarin. Adverse events linked to Pradaxa were 13 times more prevalent than when patients took Warfarin. It was noted that risks were greater for older patients and women.

March 2012: A case study published in the Journal of Neurosurgery reveals how a ground-level fall resulted in fatal, uncontrollable bleeding for an 83-year-old man who was taking Pradaxa. This is one of many incidences that concern surgeons, because there is no "reversing agent" for Pradaxa that allows doctors to stop excessive bleeding. Doctors treating Pradaxa victims such as the man in the case study may be unable to prevent their patients' deaths.

Drug Manufacturer's Duty to Warn of Risks

Critics of Pradaxa claim that manufacturer, Boehringer Ingelheim GmbH, would have discovered the extent of the drug's dangerous side effects if the company had not rushed the drug through the approval process to beat competing drugs to the market. Boehringer is also accused of deceptively promoting Pradaxa as a completely safe alternative to warfarin, although experts say Pradaxa needs to be monitored just as closely as its predecessor. It is the drug maker's responsibility to conduct thorough testing for potential deadly side effects and warn users of the extent of all risks. Boehringer did not uphold this responsibility and those individuals and families affected by their negligence should consider speaking with legal counsel to understand their rights.

Dangerous Pradaxa Complications Surface

June 2012: European Medicines Agency (EMA) acknowledges fatal bleeding with Pradaxa and encourages clearer guidance with usage.

May 2012: Complications require Pradaxa users to stop taking the drug far more frequently than those taking the older warfarin, according to preliminary findings from research conducted by Dr. Mark Wurster and presented at the Thrombosis & Hemostasis Summit of North American 2012.

January 2012: Cleveland Clinic researchers associated a 33 percent increased risk of heart attack and heart disease with Pradaxa use, compared to other anticoagulant drugs

December 2011: FDA releases safety warning about extreme and potentially fatal bleeding risks associated with Pradaxa use

November 2011: Boehringer admits to knowledge of at least 260 fatal bleeding cases – 5 times the amount accounted for earlier that month

November 2011: Boehringer calls 50 deaths "reasonable order of magnitude"

2011: Manufacturer Boehringer Ingelheim GmbH confirms deaths in patients who were taking Pradaxa, according to German newspaper Die Ziet

Weeks after Pradaxa's October 19, 2010 approval date: Medwatch reports more adverse events linked to Pradaxa than 98.7 percent of drugs monitored

Contact Us

If you have suffered excessive bleeding or a heart attack after Pradaxa use or if you have lost a family member after he or she took Pradaxa, you deserve compensation. Contact our office today for a free consultation with one of our attorneys. We will explain your legal rights and options and help you determine the best course for your case.

If you decide to file, we will guide you every step of the way and tenaciously fight on your behalf to get you the financial restitution you deserve. Compensation may include:

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  • Medical bills or funeral costs
  • Loss of income or financial support
  • Other associated financial burdens
  • Physical and emotional pain and suffering

Why is Pradaxa Deadly?

Pradaxa is an anti-coagulant, or blood thinner, used to prevent blood clots and strokes in people with non-valvular atrial fibrillation. It's also prescribed for off-label uses. Patients with renal impairment are especially at risk for Pradaxa complications, because their kidneys are incapable of flushing out all of the drug. Thus, an excessive level of Pradaxa builds up in their bodies, leading to significant bleeding risks. Pradaxa is especially dangerous, because it has no known clotting agent, meaning when Pradaxa users begin to bleed excessively, there is no way for doctors to stop the bleeding. This can cause a Pradaxa user to bleed to death.

The FDA suggests seeking immediate medical care if you develop any of the following symptoms:

  • Unusual bleeding from the gums
  • Frequent nose bleeding
  • Menstrual or vaginal bleeding that is heavier than normal
  • Bleeding that is severe or you cannot control
  • Pink or brown urine
  • Red or black (tar-looking) stools
  • Bruises that happen without known cause or that grow larger
  • Coughing up blood or blood clots
  • Vomiting blood
  • Vomit that looks like coffee grounds