DALLAS--(BUSINESS WIRE)--Powers Taylor, LLP, a plaintiff’s pharmaceutical law firm, has begun an investigation in potential lawsuits against the manufacturers and distributors of Pradaxa®, a prescription drug that was approved to reduce the risk of strokes in high-risk patients. Although the drug was only approved for use in the United States in October 2010, it has already generated an abnormally high number of adverse-event reports. These reports include 260 fatalities from people who have bled to death while using the drug, which have triggered several outcries for a Pradaxa® recall.
Pradaxa® has been shown to inhibit the release of a key protein that is essential to the formation of blood clots. Because of this effect, patients who have ulcers or who suffer internal injuries may suffer much greater blood loss than persons who are not on Pradaxa®. 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.
Despite mounting evidence of these hazards, which include a January 2012 study in the Archives of Internal Medicine, and despite precautions taken in Japan, Australia, and New Zealand, the manufacturer’s distribution arm in the United States – Boehringer Ingelheim Pharmaceuticals – has taken only limited measures, making small revisions to the warnings regarding blood loss, without including a “black box” warning that is normally applied to dangerous drugs.
The investigation by the unsafe drug attorneys at Powers Taylor will focus on determining when Boehringer Ingelheim learned (or should have learned) of the potentially deadly side effects of Pradaxa®. The investigation will also reexamine the initial studies that were submitted to the Food & Drug Administration during the approval process to determine whether the company overlooked or unjustifiably down-played the risk of these “bleeding out” events. Finally, the investigation will try to determine whether the published adverse-event statistics are understated, so that doctors and patients can more accurately assess the bleeding risks of Pradaxa® use.
If you have been prescribed Pradaxa® in the past and would like additional information regarding this investigation, or if you have information regarding the Pradaxa® studies or any underreported adverse events, please contact attorney Mark Taylor at Powers Taylor LLP, toll free at (877) 728-9607 or via email at mark@powerstaylor.com.
Powers Taylor, LLP is a boutique litigation law firm that handles a variety of complex litigation matters, including pharmaceutical cases, product liability cases, and personal injury claims.