Monday, January 28, 2013

Blood Thinner Death and Injuries: The Blood Thinner, Pradaxa, Has Been Linked to Numerous Blood Loss Deaths by Blood Thinner Death Lawyer Jason S. Coomer

Blood Thinner Death and Injuries: The Blood Thinner, Pradaxa, Has No Known Antidote or Reversal Agent and Has Caused Numerous Blood Thinner Excessive Bleeding Deaths and Injuries by Blood Thinner Death Lawyer Jason S. Coomer 

The blood thinner, Pradaxa, has been marketed as a new and improved blood thinner.  However, what has not been commonly known is that the blood thinner has no known antidote or reversal agent.  As such, the blood thinner's known risk of causing excessive bleeding combined with the lack of an antidote or reversal agent can result in death and serious injuries.  Persons using Pradaxa should communicate with their physician and health care providers about the risks of Pradaxa.

For more information on this topic, please feel free to go to the following web page: Pradaxa Blood Thinner Death Lawyer and please feel free to read the below information for the FDA. 

FDA Pradaxa and Blood Thinner Safety Warnings and Information 12-19-2012

[12-19-2012] The U.S. Food and Drug Administration (FDA) is informing health care professionals and the public that the blood thinner (anticoagulant) Pradaxa (dabigatran etexilate mesylate) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, also known as mechanical prosthetic heart valves. A clinical trial in Europe (the RE-ALIGN trial)1 was recently stopped because Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than were users of the anticoagulant warfarin. There was also more bleeding after valve surgery in the Pradaxa users than in the warfarin users.

Pradaxa is not approved for patients with atrial fibrillation caused by heart valve problems.  FDA is requiring a contraindication (a warning against use) of Pradaxa in patients with mechanical heart valves. Health care professionals should promptly transition any patient with a mechanical heart valve who is taking Pradaxa to another medication.  The use of Pradaxa in patients with another type of valve replacement made of natural biological tissue, known as a bioprosthetic valves, has not been evaluated and cannot be recommended. Patients with all types of prosthetic heart valve replacements taking Pradaxa should talk to their health care professional as soon as possible to determine the most appropriate anticoagulation treatment.  Patients should not stop taking anticoagulant medications without guidance from their health care professional; stopping Pradaxa or other anticoagulants suddenly can increase the risk of blood clots and stroke.

FDA Pradaxa and Blood Thinner Safety Warnings and Information 11-02-2012 

[11-02-2012] The U.S. Food and Drug Administration (FDA) has evaluated new information about the risk of serious bleeding associated with use of the anticoagulants (blood thinners) dabigatran (Pradaxa) and warfarin (Coumadin, Jantoven, and generics). Following the approval of Pradaxa, FDA received a large number of post-marketing reports of bleeding among Pradaxa users.  As a result, FDA investigated the actual rates of gastrointestinal bleeding (occurring in the stomach and intestines) and intracranial hemorrhage (a type of bleeding in the brain) for new users of Pradaxa compared to new users of warfarin.  This assessment was done using insurance claims and administrative data from FDA’s Mini-Sentinel pilot of the Sentinel Initiative. The results of this Mini-Sentinel assessment indicate that bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin, which is consistent with observations from the large clinical trial used to approve Pradaxa (the RE-LY trial).1 (see Data Summary). FDA is continuing to evaluate multiple sources of data in the ongoing safety review of this issue.

Pradaxa and warfarin are important medications used to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation (AF), the most common heart rhythm abnormality, which causes the heart (upper chambers or atria) to beat rapidly and irregularly.  Although these drugs reduce the number of strokes in patients with non-valvular AF, they can cause bleeding, potentially leading to serious or even fatal outcomes.  The risk of bleeding is a well-recognized risk of anticoagulant drugs.
FDA has not changed its recommendations regarding Pradaxa.  Pradaxa provides an important health benefit when used as directed.  Healthcare professionals who prescribe Pradaxa should carefully follow the dosing recommendations in the drug label, especially for patients with renal impairment (when kidneys don’t function normally) to reduce the risk of bleeding. Patients with atrial fibrillation should not stop taking Pradaxa without first talking to their healthcare professional. Stopping use of anticoagulant medications such as Pradaxa can increase the risk of stroke.  Strokes can lead to permanent disability and death.

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