ISMP AFFIRMS PRADAXA LINKED TO 542 DEATHS IN US.
A recent report in CARDIOVASCULAR BUSINESS has reaffirmed prior concerns over PRADAXA and an association with adverse events. This report specifically cites to the ISMP (Institute for Safe Medication Practices ) QuarterWatch which confirms the anti-coagulant leads reports of adverse events to the U.S. Food & Drug Administration.
ISMP’s QuarterWatch, Monitoring for FDA MedWatch Reports, notes that Anticoagulants the Leading Reported Drug Risk in 2011, May 31, 2012, New Data from 2011, Quarters 3-4, identify PRADAXA at the top of FDA’s list of drugs with most frequently reported adverse reactions.
The report identifies 3,781 serious adverse events reported in 2011. Of these, 542 patient deaths, 2,367 hemorrhage cases, 291 acute renal failures, 644 strokes and suspicion in 15 liver failures. PRADAXA or DABIGATRAN accounted for so many reports of serious adverse events that it was prominent in several areas as explained in the insert below.
The ISMP report notes that PRADAXA was linked to 542 deaths. On the other hand, WARFARIN or COUMADIN related deaths were noted as totaling 72. In sum, this ISMP report confirms that “safety signals” associated with DABIGATRAN continue to mount and raise red flags. Recent label changes are arguably not likely to change prescriber behavior, unless they are connecting the dots and informed of the ISMP’s data.
The sponsors of PRADAXA BLOOD are actively investigating cases involving death, or serious personal injuries, following the use of DABIGATRAN. A FREE CASE EVALUATION is available through use of the contact form below.