The prescription drug, Pradaxa®, was approved to reduce the risk of strokes in high-risk patients. However after only about a year and a half after its appsoval in the U.S. in October 2010, the side effects from Pradaxa® reported have already reached an abnormally high number.
Included in the reports of adverse side effects from Pradaxa® are 260 fatalities from people who have bled to death while using the drug. Many are urging for a Pradaxa® recall from the FDA
The bleeding deaths appear to be related to the research which indicates that Pradaxa® may inhibit the release of a key protein that is essential to the formation of blood clots. This may make the drug very dangerous for patients who have ulcers or who suffer internal injuries. Such patients could potentially suffer much greater blood loss than persons who are not on Pradaxa®.
Accoding to the law firm, “this problem is magnified exponentially by the fact that there is no anecdote or reversing agent that can eliminate Pradaxa’s® inhibition of blood clot formation. Some of the Pradaxa® bleeding deaths have occurred while the patient was in the hospital, with doctors helpless to reverse Pradaxa’s® effect.”
Unsafe drug attorneys Powers Taylor’s investigation will focus on determining when Pradaxa® manufacturer, Boehringer Ingelheim, learned (or should have learned) of the potentially deadly side effects of Pradaxa®, says the company statement. Additionally, the investigation will reexamine some of the studies, performed during the initial approval process, submitted to the FDA. The law firm wants to determine whether the company may have overlooked or unjustifiably down-played the risk of these “bleeding out” events.