The recent death of a man due to brain hemorrhaging has illustrated serious complications that may exist for patients using the drug Pradaxa. Three doctors at the University of Utah reported in the Journal of Neurosurgery that an 83-year-old man was admitted after a routine fall in his home, but experienced extensive brain hemorrhaging that could not be stopped due to the presence of the drug in his blood. Pradaxa (dabigatran) is an oral blood thinner in class of drugs called direct thrombin inhibitors, prescribed to prevent strokes among patients with non-valvular atrial fibrillation (an irregular heartbeat).
The man, admitted after a routine fall in his home, experienced extensive brain hemorrhaging that could not be stopped due to the presence of the drug in his blood.
This case and other bleeding events have sparked a flurry of worries that the newly popular drug could carry serious negative side effects about which the manufacture failed to provide adequate warnings. It is believed that the problem with Pradaxa is that it is impossible to stop bleeding complications in patients because there is no currently known effective reversal agent to counteract the blood-thinner. This poses a considerable risk for many patients, especially the fall-prone elderly. Pradaxa is manufactured by Boehringer Ingelheim Pharmaceuticals Inc.
The U.S. Food and Drug Administration (FDA) has agreed to review post-market reports of bleeding complications, but currently advise that patients should continue to take the drug until further notice. Thus far, worries about Pradaxa have led to a label change in the United States and Europe and safety advisories in Japan and Australia. There have been reported deaths associated with the drug in Japan, New Zealand, the United States, and elsewhere. These early problems have sparked multiple lawsuits filed against Boehringer, alleging that the manufacturer failed to properly warn patients about the risk and that the drug has led to serious and potentially fatal bleeding events.
Though the FDA is still reviewing the risks of the popular blood-thinner, there may be serious potentially-fatal bleeding events that are exacerbated by the drug. If you or a loved one has suffered a bleeding complication while taking Pradaxa, you may be entitled to compensation for medical bills, lost wages, and pain and suffering. Contact a dedicated Pradaxa attorney to see if you might be eligible to pursue legal recourse through a Pradaxa lawsuit.