Kim Gale  |  December 2, 2016

Category: Legal News

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Pradaxa anticoagulant bleedingPradaxa bleeding problems have been an issue for years, and the data isn’t getting any better.

The FDA approved Pradaxa for use as an anticoagulant in October 2010. Often called a blood thinner, the medicine reduces the chances of a stroke by reducing blood clotting mechanisms.

Pradaxa Bleeding Problems Can Affect Stomach, Brain

When a blood vessel wall is damaged, it can leak blood into surrounding tissues, creating a hematoma. Pradaxa bleeding problems can include intracerebral hemorrhage (brain bleeding) and hematoma expansion.

Hematomas in the brain are dangerous because the skull is enclosed and cannot expand like skin can. When a hematoma develops in the brain, pressure builds and impairs brain function.

In 2011, a study using mice confirmed the connection between Pradaxa and hematoma expansion. The online journal Stroke, published by the American Heart Association, provided details of what happened when mice received Pradaxa.

Researchers from University Heidelberg in Germany observed intracerebral hematoma expansion during the first three hours after introducing Pradaxa. A higher dose of Pradaxa increased the hematoma volume substantially within that three-hour period.

Pradaxa works by blocking thrombin, a clotting protein. When this clotting protein is not working well, side effects may include bruising, minor bleeding, indigestion and heartburn.

When too much of the clotting protein is halted from doing its job, gastrointestinal bleeding can occur.

Pradaxa Bleeding Problems Became Known Early On

Within the first calendar year after Pradaxa entered the market, 540 people died after taking it. Thousands of others reported non-fatal side effects.

Pharmaceutical company Boehringer Ingelheim released Pradaxa onto the market before an antidote had been developed and made available. Patients who suffered from excessive bleeding while on Pradaxa were faced with the possibility that their bleeding could be irreversible.

It was about five years before an antidote, Praxbind, was approved by the FDA. But by then, the antidote came too late for many Pradaxa patients.

Critics Say One-Dose-Fits-All Has Flaws

Dr. Curt Furberg is a medical advisor to the Institute for Safe Medication Practices (ISMP), a nonprofit organization dedicated to educating the healthcare community and the public about medication safety.

Dr. Furberg, a professor emeritus of public health sciences at Wake Forest School of Medicine, says that Pradaxa has a wide variation of clot-preventing effects, depending upon the patient.

Pradaxa comes as only a single-dose medication in the United States, but it is approved in two different dosages in Europe.

Because the single does is very high initially, that factor alone can raise the risk of bleeding, he explains.

Pradaxa is marketed as a one-dose-fits-all medication. But Dr. Furberg says that even though Pradaxa might effectively prevent strokes in some patients, the dose is too low to be effective in other patients.

In yet other patients, the dose can be too high, which means an increased risk of excessive bleeding for those people.

“If you’re a patient on Pradaxa or Xarelto, I think you should talk to your physician and ask whether the drug should be switched to a safer and more effective oral [anticoagulant],” Dr. Furberg says.

The ISMP analyzed the FDA’s nearly 34,765 adverse drug event reports for blood thinners administered orally last year. The reports included almost 3,000 deaths and more than 9,500 adverse events that required hospitalization.

If you have taken the blood thinner and experienced Pradaxa bleeding problems, you could be eligible for compensation through a Pradaxa lawsuit.

In general, Pradaxa lawsuits are filed individually by each plaintiff and are not class actions.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The Pradaxa attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or Pradaxa class action lawsuit is best for you. Hurry — statutes of limitations may apply.

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