Pradaxa Side Effects Lawsuit
Pradaxa side effects may range from problems with ulcers to internal bleeding and even death. If you have been injured as a result of Pradaxa side effects you should contact our Pradaxa attorneys regarding your possible Pradaxa lawsuit.
PRADAXA (dabigatran etexilate mesylate) is a prescription Direct Thrombin Inhibitor Anticoagulant aka blood thinning medicine. Pradaxa approval was given by the FDA for medical use on October 29, 2010. Pradaxa can reduce the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should. This can cause blood clots to form, increasing your risk of a stroke. PRADAXA lowers the chance of blood clots forming in your body. Pradaxa is prescribed to replace other Anticoagulants (blood thinners) like Warfarin (Coumadin), which is what's predominantly used in the United States to treat blood clots.
Anticoagulants reduce blood clotting, which is why they are more commonly called blood thinners. Anticoagulants like Pradaxa are most commonly used in patients with atrial fibrillation, or an irregular heartbeat. This is because atrial fibrillation increases the risk of stroke, which is many times higher in patients with an irregular heartbeat.
How Is Pradaxa Different Than Traditional Blood Thinners?
Pradaxa and warfarin work differently to help reduce the risk of stroke due to Afib not caused by heart valve problems. Pradaxa is a direct thrombin inhibitor that helps to stop clots from forming by working directly on thrombin. Thrombin is the bloods central clotting agent. Thrombin works by causing certain materials in your blood to bind together to form a clot.
Warfarin is a vitamin K antagonist that helpt to stop clots from forming by interfering with vitamin K, a vitamin your body needs to form clots.
In addition to the usual side effects of other blood thinners, which can include exessive bleeding Pradaxa has no known reversal agent or Antidote. There is also no standard method to measure the anticoagulant effect of Pradaxa.
Serious Side Effects of Pradaxa
PRADAXA can cause bleeding, which can be serious and sometimes lead to death. This is because Pradaxa is a blood-thinning medicine (anticoagulant) that lowers the chance of blood clots forming in your body. To find the best dose of Pradaxa for you, your doctor should test your kidney function before you take your first dose of Pradaxa, and in some instances yearly there after. Click on the links below to learn more about who should not take Pradaxa, what conditions may increase your risk of bleeding, and when to call your doctor or seek emergency treatment.
Pradaxa is being marketed as an improvement to tradition anticoagulants such as Warfarin for patients that require frequent blood draws. However, there have already been reports of 260 deaths and other serious life threatening Pradaxa side effects reported since Pradaxa was approved by the FDA. There has not to date been a Pradaxa recall and the FDA nor the makers of Pradaxa hinted that there is any reason to have Pradaxa recalled.
Symptoms of Pradaxa bleeding side effects may include:
- Unusual bruising or bleeding
- Pink or brown urine
- Red or black tarry stools
- Coughing up blood
- Vomiting that resembles blood or looks like coffee grounds
- Bleeding from the gums
- Frequent nose bleeds
- Weakness and swelling in the hands, arms, lower legs, ankles or feet
- Joint pain or swelling
There have been two major studies of Pradaxa. The first, known as RE-LY, compared the safety and efficacy of the drug compared to warfarin in patients with atrial fibrillation. The drugs were found equally effective when 110 milligrams of Pradaxa was given, but Pradaxa was found superior to warfarin at 150 milligrams twice a day. At the higher dosage, unwanted bleeding occurred at about the same rate for both drugs.
The next study, called RE-COVER, compared Pradaxa to warfarin in patients with acute venous thromboembolism. In this condition, which involves blood clots forming in veins, patients taking Pradaxa suffered fewer minor bleeding events. An increase in dyspepsia, however, apparently led to a higher discontinuation rate for patients who had been taking Pradaxa.
Pradaxa Time Line
October 19, 2010: Pradaxa (dabigatran) receives FDA approval for reducing risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
January 2011: Pradaxa becomes available in Japan.
June 2011: Pradaxa becomes available in New Zealand.
August 2011: Japanese regulators issue a Pradaxa Safety Advisory after receiving 81 reports of serious side effects, including 5 deaths. Japanese regulators ask the Pradaxa manufacturer, Boehringer Ingelheim Pharmaceuticals, Inc., to warn doctors of the serious bleeding risk associated with the drug.
September 2011: New Zealand health officials launch an investigation after receiving reports of five Pradaxa bleed deaths.
October 6, 2011: The Institute for Safe Medication Practices reports that Pradaxa was at the top of the list for adverse events.
November 18, 2011: The European Medicines Agency in Europe reports a worldwide total of 256 fatal bleeds involving Pradaxa.
December 7, 2011: The FDA issues a Safety Communication reporting that it is performing a review of the post-market reports of serious bleeding events involving the patients that were in the clinical trial that lead to Pradaxa’s FDA approval.
May 2012: A study published in The Journal of Neurosurgery reveals that in the event of a traumatic hemorrhage in Pradaxa patients, there is no effective reversal agent.
Pradaxa Side Effects - Pradaxa Bleeding & Pradaxa Death
If you or a loved one have suffered serious side effects of Pradaxa, Pradaxa injury or death while using the Pradaxa you may be entitled to compensation. Contact the Pradaxa side effects lawyers of Ennis & Ennis, P.A. today for a free nationwide case evaluation. Our experienced Pradaxa attorneys can answer any questions you may have about Pradaxa litigation, Pradaxa side effects, a potential Pradaxa lawsuit or even a possible Pradaxa class action lawsuit. Fill out the Pradaxa lawsuit case evaluation form on this page or call toll free: 1.800.856.6405.
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