When an 83 year-old man went to University Hospital in Salt Lake City, Utah after falling at home and suffering minor trauma, his doctors never imagined he would suffer a Pradaxa serious bleeding event.
Minor Trauma Can Cause a Pradaxa Serious Bleeding Event
A case report featured in the Journal of Neurosurgery details that the 83 year-old man had been prescribed Pradaxa just a month before by his primary care physician who had diagnosed him with atrial fibrillation. Upon arriving at the hospital, the man exhibited no signs of impairment, and a brain scan showed that he had only small hemorrhages of little concern.
Within just two hours of being admitted to the hospital though, the man’s condition began to deteriorate. New brain scans showed he was suffering from extensive intracranial hemorrhaging. His doctors could do little but stand by and watch as he slipped into a coma.
The neurosurgeons who treated the man wrote this case report to alert other healthcare providers to the fact that Pradaxa has no known antidote. In fact, the doctors attempted to stop the hemorrhaging in the 83 year-old by giving him intravenous fluids and recombinant factor VIIa, which is often used to clot blood, but both treatments were ineffective.
The authors noted that because Pradaxa is broken down through the kidneys, dialysis may be the only way to reverse the effects of Pradaxa, but because bleeding events happen so suddenly, dialysis is often ineffective to stop the bleeding.
What is Pradaxa?
Pradaxa is an anticoagulant that is widely prescribed to prevent strokes and blood clots in elderly patients with atrial fibrillation. But these elderly patients are often unstable on their feet and are prone to falling, which can cause minor trauma and major hemorrhaging. Experts worry that as Pradaxa is more widely prescribed to older, frailer patients, the number of serious bleeding events will increase.
Worldwide, Pradaxa has been linked to 260 deaths as of November 2011. The U.S. Food and Drug Administration (FDA) released a safety communication for Pradaxa in December 2011, saying that it would study Pradaxa’s side effects to determine the risk of severe bleeding. In the United States, an estimated 120 deaths have been blamed on Pradaxa serious bleeding events.
While the FDA studies these adverse events, trial lawyers across the nation are standing up for consumer rights, asking manufacturer Boehringer Ingelheim for answers. Pradaxa lawsuits have been filed in U.S. district courts across the nation, alleging that Boehringer Ingelheim knew about the bleeding risks, but provided no antidote and continued to market and sell Pradaxa anyway.
To learn more about Pradaxa serious bleeding events and get the latest news on Pradaxa, visit www.vanweylaw.com. Pradaxa is not the first dangerous drug to be approved by the FDA, and it certainly will not be the last. To learn more about dangerous drug approvals, download my free ebook Prescription Drug Safety: 7 Secrets the Pharmaceutical Company Does Not Want You to Know at www.vanweylaw.com.