Man Dies from Reported Pradaxa Side Effects
March 29, 2012, 04:45:00PM. By Heidi Turner
Salt Lake City, UT: A case report published in the Journal of Neurosurgery suggests that Pradaxa side effects could be fatal and irreversible. Among side effects reportedly linked to the medication is Pradaxa bleeding, which can allegedly lead to death. Pradaxa lawsuits have reportedly now been filed by families whose loved ones were injured or died after using the medication.
Man Dies from Reported Pradaxa Side EffectsAccording to the Journal of Neurosurgery article, also reported on by Reuters (3/7/12), the subject of the case report was an 83-year-old man who had been taking Pradaxa for one month when he suffered a seemingly harmless ground-level fall in his home. Upon first being admitted to the hospital, the patient was alert and responsive, showing no signs causing alarm. CT scans showed small, minor hemorrhaging in the man's brain.
Two hours after being admitted to the hospital, however, new CT scans showed that the brain hemorrhaging had progressed. Although doctors made efforts to stop the hemorrhaging, the patient fell into a coma and died.
Researchers concluded, "Imbalance and falls are common in this [elderly] population, and intracranial hemorrhage resulting from even minor trauma may occur with increasing frequency as use of this drug becomes more widespread," (3/6/12). They further noted that there is no way to reverse the effects of Pradaxa in emergency situations, putting patients who suffer relatively minor falls at risk of serious consequences.
Pradaxa was approved by the US Food and Drug Administration (FDA) in October 2010 to prevent strokes in patients with atrial fibrillation, a condition mostly found in elderly patients. The drug, known generically as dabigatran and made by Boehringer Ingelheim, has reportedly been linked to other cases of bleeding.
According to a report by the Institute for Safe Medication Practices (1/12/12), Pradaxa generated hundreds of adverse event reports to the FDA in the first quarter of 2011. Among those were 120 deaths, 25 cases of permanent disability and 543 cases in which the patient was hospitalized. "Of 932 reports to the FDA, 505 cases involved situations where the patient experienced hemorrhage, more than any other monitored drug including warfarin, which ranked second with 176 cases of hemorrhage," the report states.
Lawsuits have reportedly been filed against Boehringer Ingelheim Pharmaceuticals, alleging patients suffered serious side effects after using Pradaxa. The lawsuits allege that Boehringer Ingelheim failed to adequately warn patients about the risks associated with Pradaxa, specifically about the risk of potentially fatal bleeding.