Pradaxa blood thinner linked to more than 500 deaths by FDA

by Heygood Orr and Pearson

A report by the Food and Drug Administration has linked the blood thinner Pradaxa to more than 500 deaths in 2011 alone. Medical experts have accused the FDA of not subjecting Pradaxa to sufficiently rigorous testing before the drug was approved for sale, stating that Pradaxa carries unique risks not found with other blood thinning drugs.

Pradaxa was approved for sale in the U.S. by the FDA in 2010. In the two years since it received approval, Pradaxa has become a blockbuster drug, totaling more than $1 billion in sales during that time.

But during that period, health professionals have begun to raise concerns that Pradaxa may be much more dangerous than other blood thinners on the market. Unlike warfarin, which has been used for decades, Pradaxa has no antidote to reverse the bloodthinning properties of the drug for patients who develop excess bleeding. As a result, even though the FDA has found that the number of excessive bleeding cases with Pradaxa is no higher than the number found with warfarin, the number of deaths due to excessive bleeding among Pradaxa patients is significantly higher.

According to reports received by the FDA, Pradaxa is believed to have caused at least 542 deaths in 2011. The Institute for Safe Medication Practices, a non-profit group based in Pennsylvania, says that Pradaxa was linked to more cases of injury or death than any of the other 800 drugs that it monitors.

More than 100 Pradaxa lawsuits have already been filed on behalf of patients who were injured or killed after taking the drug. Lawyers involved in these cases say that thousands of additional lawsuits are expected to be filed in the near future.

The lawyers at Heygood, Orr & Pearson are among the nation’s leaders in handling cases involving dangerous pharmaceutical products such as Fentanyl, Vicodin, Hydrocodone, OxyContin and Oxycodone, Methadone, Hydromorphone and others.

If you or a loved one has experienced the tragedy of losing a family member as a result of a drug or medical device, you and your family deserve answers to your questions. If the loss was as a result of a prescribing error, you have the right to demand that the responsible healthcare provider be held accountable. Contact us for a free consultation so we can help you determine the best way to protect your legal rights and interests.

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