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Pradaxa FDA Warnings


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Pradaxa (dabigatran) is a blood thinner manufactured by Boehringer Ingelheim. Approved by the FDA in October 2010, Pradaxa is used to prevent blood coagulation, making strokes less likely in patients with atrial fibrillation (AF). Patients with AF have a cardiac arrhythmia (off-rhythm heart beat) that significantly increases the risk of stroke. Pradaxa was released to treat this condition in a more effective way than other leading anticoagulants. It is true that Pradaxa requires less management from your doctor but it may also increase your risk of serious health complications. The FDA has warned that taking Pradaxa may significantly increase your risk of excessive bleeding. Other studies have shown that dabigratan is linked to a higher likelihood of myocardial infarctions (heart attacks).

Free Case Confidential Evaluation If you or your loved one has suffered from a Pradaxa side effect, you should contact our law firm immediately for a free confidential case evaluation. Our law firm can help evaluate your case and assist you in filing a Pradaxa lawsuit. You may be entitled to compensation for your injury, medical expenses, pain and suffering, and more.

Pradaxa Background

Pradaxa is the first major, alternative blood-thinner since the release of warfarin in the 1950s. Warfarin and Pradaxa both make blood clots less frequent in the body but they do so through different mechanisms. Warfarin diminishes the body’s levels of Vitamin K, a substance needed for the chemical process of blood coagulation. Pradaxa achieves anticoagulation by disabling the effects of thrombin. Thrombin is a protein that is crucial in the process of preventing blood loss at a site of injury. By clotting the blood, thrombin stops blood flow and prevents excessive bleeding. Pradaxa is part of a class of drugs called thrombin inhibitors, which reduce the coagulative effects of thrombin.

Doctors and patients have gravitated toward Pradaxa, as opposed to warfarin, because taking the drug is relatively maintenance free. Patients taking warfarin need to see their doctor regularly to check blood levels and change dosage. According to its manufacturer, Pradaxa patients do not need to be maintained as regularly. This improvement has led to a significant boost in Pradaxa prescriptions over the last three years. As of August 2012, more than 3.7 million patients in America were receiving a prescription for Pradaxa. Considering Pradaxa costs around $3,000 a year (compared to warfarin’s $200), experts have estimated that the drug will be a financial success for Boehringer Ingelheim. Indeed, in 2012, Pradaxa sales totaled over the $1 billion mark.

The future of Pradaxa sales is unclear, however, as the safety profile of the drug has become increasingly scrutinized. Lawsuits have been filed by over 650 Pradaxa patients that suffered bleeding issues when taking the drug. Cardiology research has continually shown a link between dabigatran and heart attacks. Pradaxa is still an effective drug for millions of people, but users should be aware of the risks before starting a prescription.

Why is Pradaxa a Problem?

In 2011, 542 Pradaxa-related deaths were reported to the U.S. Food and Drug Administration. These deaths generally occurred because, although stopping blood clots is the purpose of Pradaxa, blood thinning can lead to dangerous amounts of bleeding after a cut or fall. In 2012, the public began to take note of the risks of Pradaxa, with medical research and lawsuits following soon after. Reuters reported that the “growing complaints of risks and deaths tied to [Pradaxa has] made some top U.S. cardiologists hesitant to prescribe [it].” With Pradaxa, unlike warfarin, there is no antidote to reverse the blood-thinning effects of the drug. So if a patient begins to bleed internally, it can be very difficult to stop the process. One trauma surgeon in Houston noted that when Pradaxa-patients come into his hospital with excessive bleeding he feels “hopeless,” and “that’s a very bad feeling…”

Pradaxa FDA Warnings

The FDA has said that Pradaxa is no more likely to cause bleeding than other anticoagulants; but they still stress that doctors need to be cautious when prescribing the drug. When comparing Pradaxa and warfarin, “the rate of serious bleeding was similar between the two drugs. However, after Pradaxa’s approval, a large number of reports of bleeding were submitted to FDA’s Adverse Events Reporting System (AERS) database.” Fatal bleeding events were being reported to the FDA as early as a few months after the drug was released on the U.S. market. Still, the agency notes that “bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies.” This may be true, but there are still valid safety questions concerning 1) the inability for doctors to reverse the anticoagulation in Pradaxa and 2) the connection between Pradaxa and serious cardiovascular events.

Pradaxa Adverse Event Reports

In 2011, there were over 3,781 adverse events reported to the FDA in relation to Pradaxa. According to an Institue for Safe Medicine Practice report Pradaxa accounted “for 3,781 domestic, serious adverse events overall in 2011 (both manufacturer and direct reports), including 542 patient deaths.” Furthermore, “it surpassed all other regularly monitored drugs in reports of hemorrhage (2,367 cases), acute renal failure (291), and stroke (644). It was also suspected in 15 cases of liver failure.”

Do I have a Pradaxa Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Pradaxa lawsuits. We are handling individual litigation nationwide and currently accepting new Pradaxa Lawsuits.

Free Pradaxa Lawsuit Evaluation: Again, if you or a loved one has taken Pradaxa and suffered side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a Pradaxa lawsuit and we can help.

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