Heba Elsherif  |  July 21, 2017

Category: Legal News

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Pradaxa bleeding emergency hemorrhagePradaxa, whose generic name is dabigatran, is a comparatively new anticoagulant that was announced as a substitute for warfarin to help prevent strokes in patients who have atrial fibrillation.

However, many Pradaxa bleeding complications have been reported since the drug’s arrival on the market. Like other anticoagulants, Pradaxa has been associated with an increased risk of episodes of heavy bleeding.

Some of the symptoms of Pradaxa bleeding complications include but are not limited to: headaches, lethargy, and dizziness; common nose bleeds and bleeding from gums; weakness in the body’s lower and upper extremity such as in the feet, lower legs, ankles, arms, and feet; coughing blood; brown or pink colored urine; black or red stool; and abnormal bleeding or bruising.

The anticoagulant is part of a class of drugs called “direct thrombin inhibitors.” The class of drugs is known to impede the enzyme in the blood that triggers the blood to coagulate.

There have been several reports by the U.S. Food and Drug Administration due to Pradaxa bleeding complications. For example, according to a QuarterWatch report by the Institute for Safe Medication Practices, in Pradaxa’s first three months on the market, it was suspected in 307 adverse event reports filed with the U.S. Food and Drug Administration.

The report states that “within just weeks of its approval on October 2010, this new drug, approved to reduce the risk of stroke in patients with atrial fibrillation, moved to near the top of our adverse event rankings, with more reports than 98.7% of the drugs we regularly monitor.

A letter published in medical journal Therapeutics Initiative in October 2011 examined the FDA’s approval of Pradaxa and stated that some of the clinical trials used to determine its safety and efficacy may not have been reliable.

The letter stated that within the clinical trials known as RE-LY, a separate, non-blinded study was done that had compared warfarin to Pradaxa but allowed for potential mistakes and bias to affect the results. The letter’s conclusions states, “the comparison between warfarin and dabigatran was not blinded and thus all outcomes are subject to performance and ascertainment bias favouring dabigatran.”

“This interpretation is reinforced by the FDA review, which found that lack of blinding of patients and clinicians led to ‘differential treatment of patients during the study period’ …”

The FDA issued its own Drug Safety Communication in December 2011, informing physicians and the community of Pradaxa bleeding complications.

According to the FDA’s announcement, it stated that it was issuing the drug safety communication as a result of the “large number of post-marketing reports of bleeding among Pradaxa users.”

The FDA indicated that it was, as a result, investigating the “actual rates” of intracranial hemorrhage and gastrointestinal bleeding that was occurring in comparison to patients using warfarin.

Moreover, while the FDA indicated that bleeding is a known adverse health effect that may occur with all blood thinners, the FDA noted that it was specifically looking into whether there is abnormal occurrence to the side effects of Pradaxa.

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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