Side Effects of Pradaxa

The blood-thinning drug Pradaxa has been prescribed to reduce the risk of stroke in thousands of patients with atrial fibrillation, or an irregular heart rhythm.

Pradaxa (dabigatran etexilate mesylate) works by inhibiting an enzyme in the blood called “thrombin” that is involved in blood clotting. An irregular heartbeat increases the risk of developing blood clots, which can possibly cause a stroke.

However, soon after the U.S. Food and Drug Administration (FDA) approved Pradaxa for the U.S. market in 2010, the agency warned that the drug might cause serious uncontrollable bleeding in its users. Other studies suggest that Pradaxa can cause an increased risk of myocardial infarction (heart attack) or acute coronary syndrome.

Bloomberg News has reported that Pradaxa manufacturer Boehringer Ingelheim acknowledges that its drug has been linked to more than 250 deaths worldwide.

Internal Bleeding Caused by Pradaxa

It is understood that bleeding is a complication of blood-thinning medications, and it may lead to serious medical problems or even death. But since December 2011, the FDA has investigated whether patients who take Pradaxa suffer from uncontrollable internal bleeding more frequently than would be expected.

In November 2012, the FDA said it could not conclude that Pradaxa causes bleeding more often than warfarin, the next most commonly used anticoagulant. It advises that healthcare professionals who prescribe Pradaxa carefully follow dosing recommendations on the drug’s label, especially for patients with renal (kidney) impairment, to reduce the risk of bleeding.

The American Heart Association, meanwhile, explains that you are at a higher risk of suffering internal bleeding as a side effect of Pradaxa if:

  • You have a history of bleeding
  • You are older than 75 years of age
  • You have kidney problems
  • You have a stomach ulcer or other problems with stomach or intestinal bleeding
  • You are taking other medications that also increase your risk of bleeding.

Internal bleeding is a serious matter. If you have any of these symptoms of internal bleeding, contact your doctor immediately:

  • Severe or uncontrollable external bleeding
  • Frequent nose bleeds
  • Unusual bleeding from the gums
  • Coughing up blood
  • Vomiting blood or vomit that looks like coffee grounds
  • Heavier than normal menstrual or vaginal bleeding
  • Pink or brown urine
  • Black or red stools
  • Bruises that have no known cause or that grow larger
  • Unexplainable pain, swelling, or joint pain
  • Headaches with dizziness or weakness.

Pradaxa Linked to Heart Attacks

An article in the March 12, 2012, issue of the Archives of Internal Medicine says researchers from the Cleveland Clinic concluded that Pradaxa is associated with an increased risk of myocardial infarction (MI or heart attack) or acute coronary syndrome (ACS). “Acute coronary syndrome” is an umbrella term for situations where the blood supplied to the heart muscle is suddenly blocked.

Common signs of acute coronary syndrome include:

  • Chest pain or discomfort, which may involve pressure, tightness or fullness
  • Pain or discomfort in one or both arms, the jaw, neck, back or stomach
  • Shortness of breath
  • Feeling dizzy or lightheaded
  • Nausea
  • Sweating.

Pradaxa may also cause many other side effects that require medical attention, according to the U.S. National Library of Medicine’s PubMed Health website.

Get Legal Help if You Have Pradaxa Side Effects

If you think you or a loved one of yours suffered uncontrollable or excessive bleeding, heart attack or acute coronary syndrome because they took Pradaxa, please contact Salvi, Schostok & Pritchard P.C., at our toll-free number or through our online form.

We are currently investigating cases of injuries and death believed to be attributable to Pradaxa. We can provide you with a free consultation to determine whether you may be eligible for compensation.