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Update from the FDA Met with Criticism


Pradaxa Law FirmA new announcement from the FDA indicates that following their evaluation, Pradaxa users did not find an increased risk of bleeding when compared with the use of a associated drug, warfarin. While this announcement was in fact truthful, the FDA failed to state that the drug warfarin includes a reversal agent which would be essential in the event where a bleeding emergency is arises. Pradaxa, on the contrary, does not include an antidote which would be imperative for anticlotting and the prevention of severe and possibly fatal bleeds.

Over 100 lawsuits have been filed in regard to the adverse effects after use of the drug Pradaxa to date. If you or a loved one has suffered a serious bleed following the use of Pradaxa, Lewis & Keller requests for you to contact us immediately for a Free Case Evaluation to discuss your legal options.

Pradaxa was first approved for use in the United States in October 2010 to prevent strokes in patients with atrial fibrillation. Characterized as an irregular heartbeat condition, atrial fibrillation is common among elderly patients. Pradaxa inhibits the enzyme that is responsible for clotting blood; however, in some instances this works to the detriment of the patient. If a patient who has been taking Pradaxa suffers from a serious bleeding event, their blood can fail to clot. This can result in gastro-intestinal bleeds, causing the hospitalization of the patient and sometimes leading to the patient bleeding to death.

Symptoms of Pradaxa Internal Bleeding

Much like other anti-coagulants, Pradaxa’s benefit of reducing the risk of a debilitating or fatal stroke comes with the chance of internal bleeding. If you or a loved one has been prescribed Pradaxa and has experienced any of the following symptoms, contact your physician immediately:

  • Unusual bleeding or bruising
  • Coughing up blood
  • Pink or brown urine
  • Frequent nosebleeds
  • Red or black tarry stools
  • Swelling and weakness of the hands, arms, lower legs, ankles and feet
  • Joint swelling and pain
  • Headaches
  • Vomiting that either looks like blood or resembles coffee grounds
  • Dizziness
  • Lethargy

Pradaxa Internal Bleeding Wrongful Death Claims

Boehringer Ingelheim, the manufacturer of Pradaxa, has reported approximately 260 deaths related to the drug. The FDA is currently reviewing reports of serious internal bleeding in elderly patients who were prescribed the anti-coagulant. If you or a loved one has suffered from using Pradaxa, do not wait to contact the Pradaxa gastro-intestinal bleed lawyers at Lewis & Keller for a free and confidential case evaluation.

Agencies outside of the United States are also concerned with Pradaxa internal bleeding deaths. European regulators have recommended that patients who may begin a Pradaxa regimen should first have their kidneys checked by a physician. An elderly patient with weak kidneys runs a higher risk of suffering from internal bleeding. Additionally, regulators in Japan have required Boehringer Ingelheim to issue a strong warning to physicians regarding the possibility of deadly bleeding linked to Pradaxa use.

Pradaxa Gastro-Intestinal Bleeding Lawsuits

At Lewis & Keller, we believe that when a pharmaceutical company puts patients at risk with their products, they should be held accountable. If you or someone you love has suffered from internal bleeding after taking Pradaxa, contact our dangerous drug attorneys as soon as possible. You may be eligible to receive compensation for medical bills, lost wages, pain and suffering. If a loved one has passed away due to the negative side effects of Pradaxa, the deceased’s dependents may be able to collect wrongful death damages.

Recovering from damages caused by dangerous drugs is difficult. The last thing you want to worry about while you’re recuperating is your financial stability. Let us help. Contact our dangerous drug lawyers today. A member of our team will be able to assess your claim and guide you on how to proceed in your pursuit for justice.

For more information on the legal rights which may be available to Pradaxa injury victims and their families, or to schedule a no obligation consultation with a lawyer, complete the free case evaluation form on this page to begin exploring your legal options.

It is likely that we will associate another law firm more experienced in defective drug and product liability claims to assist us in prosecuting your claim, all at no additional cost to you.