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Could the FDA’s Findings for Pradaxa Bleeding Rates Be Wrong?

Because of the many reports of Pradaxa side effects and deaths, the drug has raised safety concerns due to its fatal bleeding risks. According to the Institute for Safe Medication Practices (ISMP), there were more unfavorable reports regarding Pradaxa in 2011 – more than any other drug in several categories, including acute renal failure, stroke, and hemorrhage.

While Pradaxa has been available to U.S. patients for two years and there has been much concern over the drug in this last year, the U.S. Food and Drug Administration (FDA) decided to reassess Pradaxa bleeding and released new findings. On November 2, 2012, the FDA stated that the bleeding rates for Pradaxa are not higher than warfarin, its competitor drug. The exact statement from the FDA is that “bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin.”

What Others Are Saying About the FDA’s New Report

However, many doctors and others in the medical community do not agree with the FDA’s findings because Pradaxa, unlike warfarin, does not have an antidote to stop the bleeding. The FDA failed to mention this in their report. If there is nothing a doctor can do to stop a patient’s bleeding or treat hemorrhaging while the patient is on Pradaxa, how can it be overlooked in the FDA’s report?

Pradaxa bleeding rates are higher than the rates associated with warfarin; however, warfarin (also known as Coumadin) has its problems as well. But there is a way to stop the bleeding for patients on warfarin – unlike Pradaxa. Dr. Richard H. Schmidt, an associate professor of neurosurgery at the University of Utah, told the New York Times, “The practical experience is that once hemorrhagic complications occur in this drug, it is much more likely to be catastrophe than with Coumadin.”

By sorting through massive amounts of insurance documents, the FDA came to the conclusion that bleeding rates for Pradaxa are not higher than warfarin. However, how can a drug lead the FDA’s list of drug-related fatalities for 2011 if it’s no more dangerous than warfarin? Many doctors and others are still skeptical of Pradaxa due to the lack of an antidote for bleeding events. Also, Pradaxa contains no black box warning to alert patients of the irreversibility of internal bleeding after taking the drug.

If you or someone you love was injured or died while taking Pradaxa, please call the Law Office of Schachter, Hendy & Johnson. Our Pradaxa lawyers may be able to help you stand up to the negligent drug maker and seek compensation for the wrongs you suffered. Call (859) 578-4444 or (888) 606-5297 to find out more about your rights in a free consultation today.

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