By Sarah Mirando  |  April 17, 2013

Category: Pharmaceuticals
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Pradaxa May Cause Serious Bleeding, Increased Risk of Stroke

By Robert J. Boumis

 

Pradaxa strokeA stroke can be devastating. In 2010, the drug Dabigatran etexilate mesylate — sold under the trade names Pradaxa, Pradax, and Prazaxa — hit the market as a way to reduce the risk of stroke in patients in immediate danger. However, life-threatening bleeding events were reported by a number of patients after taking the drug.

In a stroke, a blood clot gets lodged in the brain. This cuts off the blood supply to parts of the brain, causing serious brain damage. Pradaxa works by inhibiting thrombin. Thrombin is a protein that is vital to the process of clotting blood. When thrombin is inhibited, clotting becomes much more difficult. In the case of a patient at risk for a stroke, this can be a good thing, since it is harder for the body to form a blood clot. Without clots, a stroke cannot happen. For this reason, Pradaxa is called an anticoagulant or “blood-thinner.”

However, making it harder to form blood clots also increases the risk of catastrophic bleeding. The FDA has received hundreds of complaints regarding life-threatening bleeding events in Pradaxa users. These include things like internal hemorrhaging, gastrointestinal bleeding, and brain hemorrhages. These happen when minor injuries within the body, such as those that occur after surgery or injury, cannot stop bleeding on their own.

The manufacturer, pharmaceutical company Boehringer Ingelheim, promoted Pradaxa as superior to the conventional drug of choice Warfarin. Per Boehringer Ingelheim, Pradaxa required no change to the patient’s diet and less monitoring. However, if Warfarin leads to uncontrolled internal bleeding, its anticoagulant effects can be reversed via heavily dosing the patient with Vitamin K. This allows the patient to form blood clots and stops dangerous bleeding.

In December 2011, the United States Food and Drug Administration (FDA) issued a statement that Pradaxa’s bleeding side effects were being compared to Warfarin. They advised doctors to carefully monitor patients taking the drug. Patients were not advised to stop taking Pradaxa without consulting a physician.

Some of the symptoms of Pradaxa internal bleeding include:

  • Unexplained bruising
  • Nose bleeds
  • Vomiting blood
  • Discolored urine
  • Red or black stool
  • Bleeding guns


This is not a comprehensive list of Pradaxa bleeding symptoms.

Several Pradaxa injury lawsuits have been filed against Boehringer Ingelheim, including a number of wrongful death lawsuits. These lawsuits allege that Boehringer Ingelheim downplayed the risks of taking this medication, failing to advise patients and physicians regarding the risk of serious side effects like uncontrollable Pradaxa bleeding. The lawsuits also allege that once uncontrollable bleeding starts, it cannot be reversed in patients who took Pradaxa, as it can with Warfarin. The lawsuits further allege that Boehringer aggressively marketed Pradaxa over Warfarin despite these serious side effects.

If you or someone you love suffered from serious bleeding-related side effects after taking Pradaxa, you may feel like you have little control over your situation. However, you can take charge. You can start by visiting the Pradaxa Internal Bleeding Class Action Lawsuit Investigation. Here, you can submit information regarding your situation for review by a drug injury lawyer who specializes in this type of lawsuit. Your information will be reviewed free of charge. From here, you will receive guidance on the next steps you can take.


 

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Updated April 17th, 2013

 

All medical device, dangerous drug and medical class action and lawsuit news updates are listed in the Drug and Medical Device section of Top Class Actions.

 

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