Pradaxa And Coumadin Have Most Adverse Events Reported To FDA


The Institute for Safe Medication Practices has issued their report on adverse events caused by medications as reported to the FDA for the 3rd and 4th quarters of 2011. The anticoagulants Pradaxa and Coumadin rank number 1 and 2 respectively. Pradaxa, approved in 2010, was head and shoulders above the rest causing hemorrhage, renal failure and stroke, with a number of fatalities. Patients may want to think twice before trading the frequent required blood tests when on Coumadin for the  ’no blood tests necessary’ convenience of Pradaxa. From the report:
Dabigatran (PRADAXA), approved in 2010 for the prevention of stroke in patients with atrial fibrillation, accounted for so many reports of serious adverse drug events that was prominent in several different categories. It accounted for 3,781 domestic, serious adverse events overall in 2011 (both manufacturer and direct reports), including 542 patient deaths. It surpassed all other regularly monitored drugs in
… (Continued...)



More...