Pradaxa Patients Risk Internal Bleeding, Hemorrhagic Stroke/Brain Bleeding, And Inability To Stop Bleeding Caused By Trauma
Pradaxa is a prescription medication manufactured by Boehringer Ingelheim and used to reduce the risk of stroke and other clotting disorders in patients suffering from atrial fibrillation (a type of irregular heartbeat). It was approved for sale by the U.S. Food and Drug Administration (“FDA”) in October 2010, as an alternative to Warfarin/Coumadin therapy.
Despite its short lifespan in the U.S. market, the drug has already undergone two major label changes mandated by the FDA, the first in November 2011 strengthening the warnings with respect to patients whose kidney function is impaired, and the second in January 2012 again addressing patients with kidney impairment, and concerning an increased risk of internal bleeding/hemorrhaging in patients who used the drug as well as information indicating there was no effective antidote. These changes came on the heels of drug regulators in Japan, New Zealand and throughout Europe taking action in the face of large numbers of “adverse event” reports by users of the drug.
The adverse events that were reported include internal bleeding, gastrointestinal bleeding, ulcers, cerebral/brain bleeding and hemorrhagic stroke. They also include “atypical” or unusual bleeding following an accident or trauma. Essentially, when some Pradaxa users suffer a traumatic injury, their physicians are unable to stop the bleeding and it can lead to more serious injuries and deaths. Doctors are unable to stop the bleeding , because unlike with a drug like Warfarin/Coumadin, the is no effective antidote to Pradaxa. Its “half-life,” which reflects how long the drug remains in the body, is at least 12 hours under normal circumstances and can be much longer in patients with impaired kidney function as the drug ultimately is cleared from the body through the kidneys.
We are continuing to investigate claims of patients taking Pradaxa who have suffered from internal bleeding, cerebral bleeding and atypical bleeding events after a trauma.