Pradaxa Internal Bleeding Lawsuit - Consumer Drug Report
Pradaxa® prescribing errors: Cause of side effects?

According to a study conducted by researchers from New Zealand, a number of Pradaxa side effects are caused by prescribing errors. On March 1, 2012, a letter was published in the New England Journal of Medicine stating that 25% of the injuries caused by Pradaxa are due to prescribing errors.

Traditional blood thinning medications, such as warfarin, contain a reversing agent. This has led researchers to suggest that the adverse side effects of Pradaxa and other new blood thinners could be reduced if there was a reversing agent present.

The Food and Drug Administration issued a safety announcement in 2011 noting the importance of paying close attention to the proper method for storing Pradaxa and also included prescribing recommendations to healthcare professionals.

Pradaxa (dabigatran) is prescribed to treat atrial fibrillation not caused by a heart valve problem and is included in a class of drugs referred to as “direct thrombin inhibitors.”  Atrial fibrillation is a condition in which part of the heart does not beat properly. Because of this, blood cells form into clots, and travel throughout the body. A stroke may occur if the blood clots reach the brain and a pulmonary embolism may occur if the blood clots travel to the lungs.

The FDA approved Pradaxa in October of 2010. Shortly after the FDA approved Pradaxa for the treatment of atrial fibrillation a number of adverse side effects were reported. Side effects include internal bleeding, gastrointestinal bleeding, brain hemorrhaging, heart attack, and death.

Though no recall has been issued on Pradaxa, the FDA is currently in the process of investigating internal bleeding claims. So far, more than 500 bleeding cases were reported as a result of Pradaxa use, and only 176 bleeding cases were reported with use of warfarin.

No Pradaxa lawsuit has been filed, however, attorneys are investigating and reviewing claims brought forth by victims who claim Pradaxa caused them to suffer adverse side effects.


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