FDA to Review Pradaxa Internal Bleeding & Hemorrhaging Reports
If you have been injured by Pradaxa, you may want to contact a Pradaxa internal bleeding lawyer. The Food and Drug Administration (FDA) announced that it will be reviewing reports of internal bleeding and internal hemorrhaging linked to Pradaxa, a stroke-prevention drug. The European Medicines Agency reported 256 cases of fatal bleeding caused by Pradaxa, and cautioned doctors when prescribing the medication.
The FDA warned physicians not to prescribe Pradaxa to patients with poor kidney function. The kidneys are responsible for removing toxins from the bloodstream. In patients with poor kidney function, Pradaxa may build up in the bloodstream to unsafe levels, and the blood cannot clot. If the patient begins bleeding, a physician may not be able to stop the bleeding.
If you or someone you know has experienced internal bleeding or hemorrhaging caused by Pradaxa, you should contact a Pradaxa internal bleeding lawyer. You may be entitled to compensation by filing a Pradaxa lawsuit.
The FDA review of Pradaxa will need to determine whether bleeding is more common in patients taking Pradaxa compared to warfarin. Pradaxa is the first drug that has been approved as an alternative to warfarin, a blood-thinning medication prescribed to prevent strokes associated with blood clots.
The review will be difficult because warfarin is known to cause bleeding, which is one of the reasons why an alternative medication has been highly desired. Bleeding caused by warfarin can be easily reversed with a dose of Vitamin K. Pradaxa, however, has no such safety mechanism. Warfarin has also been used for more than 50 years and is well-known to cause bleeding, which is why physicians rarely report these adverse events.
The most recent clinical trial linked Pradaxa to serious, life-threatening side effects — including internal bleeding, internal hemorrhage, cerebral hemorrhage, and death. The findings of the RE-LY Clinical Trial were:
- 16.4% of people taking Pradaxa experience bleeding
- 3.3% experience serious bleeding
- 1.5% experience life-threatening bleeding
- 0.3% experience life-threatening bleeding in the brain.
- 17.4% of people taking Pradaxa who needed emergency surgery experienced major bleeding
Pradaxa triggers a 6% rate of major internal hemorrhages during each year of treatment
If you have been injured by this medication, a Pradaxa internal bleeding lawyer will review your case for free. You may be entitled to compensation for your injuries, medical expenses, pain, and suffering.
Pradaxa / dabigatran is manufactured by Boehringer Ingelheim. It received approval in the U.S. in October 2010. Within its first year, 1.1 million Pradaxa prescriptions were dispensed. Roughly 371,000 patients in the U.S. took the drug in the first year. It is usually prescribed to patients who have been diagnosed with atrial fibrillation, which is when the heart beats irregularly, causing blood to pool in the upper chamber of the heart. Sometimes, this pooled blood coagulates, forming a blood clot, which the heart may pump into the body. If a blood clot becomes trapped in the heart, brain, or lungs, it can cause a stroke and quickly lead to death. Pradaxa prevents strokes by inhibiting an enzyme in the blood that is necessary for clotting. It belongs to a class of medications called “direct thrombin inhibitors.” Unfortunately, sometimes the anti-coagulant properties of Pradaxa and other blood-thinning medications can work too well. When a person is experiencing a serious bleeding event, they need blood clots to stop the bleeding. If the blood cannot clot, the person may bleed to death.
How do I contact a Pradaxa Internal Bleeding Lawyer for a Pradaxa Lawsuit?
The Schmidt Firm, LLP is currently accepting Pradaxa induced injury cases in all 50 states. If you or somebody you know has experienced internal bleeding or internal hemorrhaging after taking Pradaxa, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Pradaxa Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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