FDA Warns that Pradaxa Carries Risk of Fatal Bleeding

Before any drug or medication obtains FDA-approval and is released to the public, it must undergo significant research, testing, and clinical trials.  Although all drugs carry risk of adverse side effects, sometimes, the reach of those possible risks does not become well known until the drug is used on a wider population.  When the side effects of a particular drug are widespread and potentially life-threatening, the FDA may issue a warning regarding use of the drug.  Often, patients who suffer as a result of using the medication are eligible for financial compensation from the drug manufacturer through a pharmaceutical lawsuit. Medical manufacturer Boehringer Ingelheim Pharmaceuticals has recently become the subject of litigation as a result of side effects associated with the use of Pradaxa (dabigatran), an anti-coagulant used to reduce the risk of stroke and blood clots in patients with atrial fibrillation.  When the FDA approved Pradaxa in October 2010, the organization noted risks including potentially fatal bleeding and internal bleeding, a side effect commonly associated with blood-thinners and anti-clotting drugs.  However, since that time, the number of patients experiencing life-threatening or fatal bleeding has led the FDA to investigate whether such incidents are occurring more frequently than expected.   Boehringer Ingelheim admitted to receiving reports of 260 dabigatran bleeding deaths worldwide between March 2008 and October 2011.  The FDA is investigating nearly a thousand reports of internal bleeding injury and death associated with the drug. In November 2011, the first Pradaxa lawsuit was filed against Boehringer Ingelheim, and the following month, the FDA issued a Pradaxa safety warning advising that the drug, like other anti-coagulants, carries a risk of fatal bleeding, but still provides a health benefit to patients with an increased risk of stroke.  The FDA advises, Patients with AF should not stop taking Pradaxa without talking to their healthcare professional. Stopping use of blood thinning medications can increase their risk of stroke. Strokes can lead to permanent disability and death.”  Similar warnings have been issued in Australia, Japan, and Europe. If you have suffered an injury as a result of taking Pradaxa, or if you have lost a loved one due to hemorrhaging or fatal internal bleeding caused by Pradaxa, you may be eligible for financial compensation for your injury or loss.  By filing a lawsuit against the makers of a dangerous or defective drug, you may be awarded compensation for medical expenses, pain and suffering, funeral and burial expenses, and more. Pradaxa lawsuit form is available for you to complete to help determine if you or a loved one is eligible for compensation.

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