Pradaxa warnings issued by the FDA have many patients wondering how the drug’s side effects will affect their health.


Pradaxa, a blood-thinning drug used to reduce stroke risk in patients with non-valvular atrial fibrillation (AF), has been closely scrutinized by the Food and Drug Administration in recent years. In fact, Pradaxa warnings issued by the FDA have many patients wondering how the drug’s side effects will affect their health.  Frenkel & Frenkel, a Dallas law firm, explains the warnings and Pradaxa side effects that have potentially serious health risks. Uses for Pradaxa Pradaxa, or the generic form, dabigatran, prevents blood clots from forming due to an irregular heartbeat, known as atrial fibrillation (AF).  Blood clots that form due to this common condition create a stroke risk in patients that suffer from AF.  The drug is an anticoagulant that blocks a certain clotting protein, thrombin, from forming in the blood. Pradaxa, normally taken once per day, is an oral prescription medication, and should be taken on an empty stomach.  However, the Pradaxa warning inidicates that the drug causes serious bleeding, often internal, and patients with undiagnosed stomach ulcers are at increased risk of this Pradaxa side effect. Normal Side Effects Some Pradaxa side effects are relatively minor, including easy bruising, as well as nosebleeds or excessive bleeding from minor cuts.  In addition, 35 percent of patients experience gastrointestinal problems, including indigestion, heartburn, abdominal pain or discomfort, reflux disease, and ulcers according to  Most of these side effects are not included in the Pradaxa warning issued by the FDA. Potentially Dangerous Side Effects The Pradaxa warning issued by the FDA indicates that serious bleeding has occurred in patients taking the drug, and that this bleeding may lead to fatal outcomes.  Although the drug label warns about bleeding, the FDA is researching whether fatal bleeds in patients taking Pradaxa happen more frequently than those taking other anticoagulants.  When Pradaxa affects blood proteins significantly, serious bleeding may occur, and, in some cases, patients have died as a result of bleeding in the brain. Symptoms of Bleeding One of the reasons for the Pradaxa warning is to make patients aware of potential bleeding problems and make them aware of signs of bleeding so they seek medical attention quickly.  Notify your doctor if you suffer from any of the following Pradaxa side effects:

    • Unusual pain, swelling or discomfort
    • Persistent and frequent nosebleeds
    • Unusually heavy or prolonged menstrual flow
    • Pink or dark urine
    • Coughing up blood
    • Vomit with blood or the appearance of coffee grounds
    • Severe headache
    • Dizziness or fainting
    • Unusual or persistent tiredness or weakness
    • Bloody, black or tarry stools
    • Severe heartburn, nausea or vomiting
    • Vision changes
    • Confusion
    • Slurred speech
    • Weakness on one side of the body

If you have taken Pradaxa and suffer from any of these symptoms, contact your doctor immediately.  If you have suffered from excessive bleeding while taking Pradaxa, call Frenkel & Frenkel or complete this form.

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