Severe Internal Bleeding Caused by Pradaxa

Pradaxa (generic dabigatran) is a prescription blood thinner. It acts as an anticoagulant (anticlotting).

Pradaxa is used to prevent blood clots and reduce the risk of stroke in people with a certain type of irregular heartbeat (atrial fibrillation). Pradaxa was introduced to the U.S. market in October 2010. It was meant to replace warfarin (Coumadin), which is a difficult to handle, decade-old blood thinner. Have you been hurt by this drug?

Unlike Coumadin, Pradaxa lacked an agent to reverse its anticlotting effects.  While uncontrollable bleeding in Coumadin users could be reversed with vitamin K, no such antidote exists for Pradaxa.

If a Pradaxa user unexpectedly suffers a bleeding event after a fall, accident, or hemorrhage, it may be difficult, or even impossible to stop the bleeding. In many cases, the patient will die as a result. Furthermore, while Coumadin patients can be given a dose of vitamin K before proceeding with emergency surgery, such an option does not exist for Pradaxa patients. The only way to reverse the anticlotting effects of the drug is to perform dialysis, which can take several hours. Since there is no specific agent or medication that will reverse a Pradaxa bleed, instead, the patient’s body must naturally eliminate Pradaxa by way of the renal (kidneys) system.

Patients taking Pradaxa and undergoing surgery had a much greater chance of having a stroke or symptoms, which could lead to a stroke.  Internal bleeding during surgery can be corrected if a patient is on warfarin, but it is much harder to treat internal bleeding if the patient is taking Pradaxa.

The manufacturer of Pradaxa, Boehringer Ingelheim of Germany, failed in its duty to keep consumers safe from unreasonable harm and to provide adequate warnings with its drug.

A new study published in the New England Journal of Medicine warned that the lack of an effective treatment for severe bleeding caused by Pradaxa may put the lives of patients taking the drug at risk.

Many patients who are prescribed blood thinners are elderly, and therefore more susceptible to falls. A patient taking Pradaxa can end up with a fatal hemorrhage due to the nature of dabigatran, even if the patient had a minor injury.

Pradaxa has recently been linked by Cleveland Clinic Researchers with a 33 percent increase in risk of heart attacks or heart disease symptoms. The researchers reviewed the results of trials involving 30,514 patients and 7 separate studies, according to CBS News.

Pradaxa has been prescribed to more than a million patients. In November 2011, Pradaxa manufacturers Boehringer Ingelheim confirmed reports of 260 fatal bleeding cases worldwide over a three-year period.

According to an article in The Journal of Neurosurgery, Emergency Room doctors at University of Utah discussed an 83-year-old patient being seen after sustaining a fall. The doctors said that he was initially completely alert and responsive to all verbal commands. A brain CT showed superficial areas of bleeding in the brain. Two hours after his arrival to the Emergency Room, his neurologic condition deteriorated quickly. A follow-up brain CT scan showed extensive hemorrhaging in the brain. The doctors were unsuccessful in stopping the bleeding. Pradaxa bleeding complications are irreversible. There is still no antidote available.

Pradaxa has been initially linked to “bleeding events,” which involve brain hemorrhaging, kidney bleeding, heart attack, and sometimes death. Internal bleeding may be the most serious of these symptoms. Complications of Pradaxa are uncontrollable internal bleeding and fatal bleeds among patients taking the blood thinner.

Warning signs that Pradaxa patients may be experiencing internal bleeding are pink or brown urine, red or black tarry stools, bruises that happen without known cause and get larger in size, coughing up blood or blood clots, and/or vomiting blood or vomit that looks like coffee grounds.

When untreated, blood clots can travel to the brain and cause stroke, which can, in most cases, lead to death, or blood clots can travel to the lungs (pulmonary embolism) and lead to death. Excessive bleeding from Pradaxa is potentially deadly, especially because there is no antidote to stop the bleeding.

Patients and their families allege that they were never warned of the risk of uncontrollable internal bleeding while on Pradaxa. Users of Pradaxa need to know the symptoms and side effects, so they may have opted for Coumadin or another blood thinner drug instead.

According to an April 24, 2012 article in The Wall Street Journal, Pradaxa reached the $1 billion sales mark for the twelve-month period ending in February.

Although all anticoagulants carry a risk of internal bleeding, most have a reversal agent available to doctors in emergency situations. A March 6, 2012 report by the Journal of Neurosurgery detailed a specific case and complaints by doctors, that once Pradaxa causes internal bleeding in a patient, there is very little they can do to stop it.

Boehringer Ingelheim should be held accountable for failing to test its product adequately and misleading doctors and patients with assurances that Pradaxa is a better drug than older options.

Although Pradaxa can be a life-saving drug, unfortunately, the side effects can be life-threatening. If you are currenlty taking Pradaxa, and are experiencing any of the mentioned side effects, you should contact one of our attorneys at 1-800-246-HURT (4878).

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