Pradaxa is the name brand of a drug, also called Dabigatran, manufactured by the German pharmaceutical company Boehringer Ingelheim, It was approved by the federal Food and Drug Administration (FDA) in October 2010 to treat atrial fibrillation.
Atrial fibrillation is the most common type of arrhythmia, a heart condition in which the rate or rhythm of the heart is too fast, too slow, or irregular. With atrial fibrillation, the electrical signals which control the rate at which the atria—or upper chambers of the heart—contract begin to function poorly, causing the heart to contract quickly or irregularly (“fibrillate”). This, in turn, causes blood to pool in the atria, rather than flow into the lower chambers of the heart, or ventricles. This pooling blood can clot, and thereby greatly increase the risk of stroke or heart failure, particularly if the heart rhythm is very rapid.
Atrial fibrillation affects roughly two million people in the United States. Its causes vary widely, and include conditions such as dysfunction of the sinus node, coronary artery disease, pericarditis, hyperthyroidism, hypertension, and other disorders. Atrial fibrillation usually arises in individuals who have high blood pressure, heart failure, or diseases of the heart’s arteries or valves. As with many ailments, the possibility of developing atrial fibrillation increases with age. It is estimated that from three to five percent of all adults over the age of 65, and nearly 15 percent of Americans over the age of 80, suffer from atrial fibrillation. Without treatment, atrial fibrillation can increase the risk of stroke up to five times higher than those who do not have the condition.
Many people who have atrial fibrillation do not experience symptoms, and it is a condition that can be sporadic or ongoing. Once diagnosed, most doctors prescribe an anti-coagulant, or blood-thinner, as a preventative measure for stroke. Atrial fibrillation increases the risk of clots forming, and a stroke occurs when a blod clot becomes lodged in an artery, preventing the flow of blood—and oxygen—to the brain. Because anti-coagulants prevent clots from forming, they decrease the risk of stroke. However, anti-coagulants carry with them alternative risks.Pradaxa Prescribed to Atrial Fibrillation Patients May Have Caused Serious Bleeding Events, Including Events Leading to Death
For nearly 60 years, the most commonly prescribed anti-coagulant—for a number of heart conditions, including atrial fibrillation—has been warfarin, commonly marketed under the name Coumadin. Coumadin is a powerful anti-coagulant, and those who take it are required to comply with an extensive regimen that includes frequent testing of blood in order to regulate the dosage and to monitor blood-thinning, as well as careful observation of diet and other drug interactions; moreover, it has serious side effects. Consequently, a large number of individuals who might benefit from the stroke-preventative features of Coumadin are either reluctant to or refuse to take it. As a result, pharmaceutical companies have long sought to formulate alternative medicines that would be less burdensome to take.
When the German drug manufacturer Boehringer Ingelheim developed Pradaxa, and the FDA approved it for use in the United States to prevent strokes in individuals who suffered from atrial fibrillation, many patients and doctors believed that it would be a boon to heart patients. One of the perceived benefits of Pradaxa was its ease of use—it required no special diet restrictions, and the dosage was straightforward: two tablets per day.
However, after two years of use and over 2.2 million prescriptions issued for Predaxa, there appear to be some serious problems caused by Pradaxa use in some patients. The FDA has compiled reports of over 3,700 adverse affects and over 500 deaths which have been attributed to Pradaxa in 2011 alone. And although neither the FDA nor Boehringer Ingelheim have issued any recall of the drug, serious questions have arisen as to whether Pradaxa is safe for its intended use, and the FDA continues to conduct a safety review of Pradaxa for the purpose of monitoring ongoing reports of adverse effects attributed to the drug.
Most of the adverse affects and deaths have related to serious bleeding events. Because Pradaxa is an anti-coagulant, as with all anti-coagulants, there exists the risk of hemorrhaging when bleeding occurs. However, the incidents involving Predaxa seem to have arisen from internal bleeding caused by the drug itself, including gastrointestinal bleeding and brain hemorrhaging. What is more, unlike Coumadin, no “antidote” has been developed to address the anti-coagulant effects of Pradaxa once the bleeding starts. Patients who have developed internal bleeding problems using Pradaxa may be facing long-term bleeding problems, even after they have stopped using the drug.If You or Someone Close to You Has Suffered an Adverse Effect From Pradaxa, or You are Currently Taking Pradaxa, Grimes Teich Anderson may be Able to Help You
Nearly two dozen lawsuits have already been brought against the drug maker Boehringer Ingelheim by patients who have suffered adverse effects from using Pradaxa. As the litigation develops in various jurisdictions, it remains to be seen whether a fault lies solely in the drug itself, or whether other parties, including prescribing doctors, may have been negligent or contributed to negligence in prescribing the drug. In particular, while all anti-coagulant drugs carry with them specific risks, Pradaxa was not recommended for patients with specific conditions, including kidney or liver problems, or a history of gastrointestinal bleeding.
Currently, Pradaxa leads all other drugs in adverse reports to the FDA. And while there is often a higher-than-usual number of adverse reports submitted to the FDA immediately after a new drug has been introduced—particularly for a condition as common as atrial fibrillation—the concern remains high that the risks of Pradaxa use far outweigh their purported benefit, and that the drug was insufficiently tested before being released, or failed to contain sufficient warnings regarding its use and necessary precautions.
If you or someone you know takes or has been prescribed Pradaxa and you believe you have suffered adverse consequences attributable to Pradaxa, call the medical product liability and malpractice attorneys at Grimes Teich Anderson. We are interested in hearing your story and in evaluating whether you may be entitled to recovery. We are experienced assisting clients recover from injuries or wrongful death caused by defective drugs or defective medical devices. If you need help, assistance, information or advice regarding a potential case involving Pradaxa, contact Grimes Teich Anderson toll-free at 800.533.6845, or complete our confidential case evaluation form online on this website.*
Our offices are located in Asheville, Rutherfordton, Waynesville, and Spruce Pine, North Carolina, as well as in Greenville and Gaffney in South Carolina. Give us a call for your no-cost, no-obligation consultation. Remember: you will not pay any fees unless and until we recover damages on your behalf. If you would like to find out more about whether you may have a case and whether you may obtain compensation for your injuries or pain and suffering through a new or existing lawsuit regarding Pradaxa, contact us today.
*Grimes Teich Anderson LLP works on these cases with Henson & Fuerst PA, Raleigh NC but these claims will be handled primarily by associated co-counsel with offices in other state(s)
Pradaxa® is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG