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Pradaxa Bleeding Study “Flawed,” More Pradaxa Lawsuits Filed

Pradaxa Bleeding Study “Flawed,” More Pradaxa Lawsuits Filed

November 9, 2012 — The U.S. Food and Drug Administration (FDA) has concluded that bleeding is equally likely to occur in patients starting Pradaxa (dabigatran), a new blood-thinning medication, compared to Coumadin (warfarin), a blood-thinner that has been used for more than 50 years. Soon after the study was published, critics pounced on it, calling the methodology “flawed” because it does not take into account the fact that Pradaxa does not have an emergency reversal agent, unlike warfarin.

Furthermore, the study did not address the long-term outcome of the patients who suffered bleeding. For example, the drugs may have a comparable risk of bleeding, but patients who start bleeding on one drug may have a higher risk of death or serious injury.

The blood-thinning effects of warfarin can be reversed with a dose of Vitamin K in an emergency. Because warfarin has been used since 1954, most trauma doctors have experience treating warfarin patients who start bleeding. When Pradaxa was released on the U.S. market in 2010, however, many trauma doctors struggled to treat bleeding in Pradaxa patients because the drug cannot be inactivated except with dialysis. The drug manufacturer did not include this risk information in the warnings for Pradaxa.

Although there are serious risks associated with Pradaxa, the drug is quickly gaining market share as a blood-thinner for people with atrial fibrillation, a type of irregular heart rhythm that can cause strokes. According to a November 2012 article published in the New York Times called A Promising Drug With a Flaw, “By the end of 2011, after just over a year on the market, 17% of patients were being prescribed Pradaxa, compared with 44% for warfarin.”

As a growing number of people start taking Pradaxa, the FDA has received many reports of death and injury. In 2011, Pradaxa was associated with 542 deaths and more injury reports than any other drug on the market. Meanwhile, the drug manufacturer, Boehringer Ingelheim, generated more than $1 billion in profit.

Many people who were injured or have family members who died from Pradaxa side effects are now seeking justice by filing a Pradaxa lawsuit. The litigation has been centralized in a federal court, the U.S. District Court for the Southern District of Illinois. There are currently 138 lawsuits filed by 151 plaintiffs.

Do I have a Pradaxa Lawsuit?

The Schmidt Firm, PLLC is currently accepting Pradaxa injury cases in all 50 states. If you or somebody you know was injured by severe bleeding, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

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