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With No Antidote to Curb Patients’ Bleeding, Is Blood Thinner Pradaxa Breaking the Law?

pradaxaIn October, 2010, German pharmaceutical manufacturer Boehringer Ingelheim introduced Pradaxa as a competitor to the long-established blood thinner Warfarin. The drug was initially hailed for its ability to be given at a fixed dose without the need for frequent adjustments. Unlike those who used Warfarin, individuals who used Pradaxa didn’t need to submit to regular blood tests or dietary restrictions.

Dangerous history of patient injury

In November 2011, disturbing findings began to emerge about Pradaxa. After initially claiming only 50 people had died as a result of taking the drug, Boehringer admitted ten days later that the actual number was 260. Boehringer defended the deaths in the press, saying that the numbers were lower than expected, given the number of people in their clinical trials. At the time, Boehringer estimated that nearly half a million people worldwide used Pradaxa.

Reduced clotting, increased risk of uncontrolled bleeding

Pradaxa works as a “direct thrombin inhibitor;” lessening the effect of the blood’s central clotting agent. While the drug helps prevent drug clots, it also increases patients’ risk of bleeding to death – especially since there’s no reversal agent. By comparison, Warfarin (which entered the U.S. market in 1954) has several established antidotes, including vitamin K injections.

Just two years after its U.S. release, numerous lawsuits are pending against Pradaxa, saying that Boehringer inadequately warned patients that the drug has no antidote.

Elderly Patients at Higher Risk

Pradaxa is commonly prescribed to elderly patients to treat atrial fibrillation, a form of irregular heartbeat that can increase the risk for a stroke. Many fatal bleeding injuries in this population are triggered by falls, including an episode recorded in the May edition of the Journal of Neurosurgery. The Journal writes of an 83-year-old man who suffered a fatal brain hemorrhage after simply falling to the floor. The man had been on Pradaxa one month.

As the journal writes:

“Imbalance and falls are common in this population, and intracranial hemorrhage resulting even from minor trauma may occur with increasing frequency as the use of Pradaxa becomes more widespread.”

Elderly patients who are over 75 years old and have pre-existing kidney problems should use extra special caution when considering Pradaxa. If you have a loved one who uses a blood thinner, be sure to be proactive in asking questions about his or her medication. Since bleeding from Pradaxa can often occur in private areas, patients can be understandably reluctant to discuss their symptoms.

The FDA encourages family members to watch out for:

  • Unusual bleeding from the gums
  • Menstrual or vaginal bleeding that’s heavier than normal
  • Pink or brown urine
  • Red or black stools (tar-like appearance)
  • Bruises that appear without a known cause
  • Coughing up blood or vomit that looks like coffee grounds

Legal Options For Deaths Related To Pradaxa

With a complication rate far higher than was disclosed by the manufacturer, Pradaxa who have suffered complications including: internal bleeding, heart attack, DVT, gastrointestinal problems or death may be entitled to pursue a lawsuit or claim against the manufacturer.  Rosenfeld Injury Lawyers LLC is currently reviewing Pradaxa cases throughout the country.  If you have questions about your situation, our Pradaxa lawyers offer free consultations to evaluate your situation and can answer questions you have about the status of the litigation.