On April 5, 2012, ISMP (“INSTITUTE FOR SAFE MEDICATION PRACTICES”) released their trademarked QuarterWatch and updated information relating to PRADAXA (DABIGATRAN EXTILATE). ISMP’s latest analysis affirmed their prior analysis and concerns over the potential for overdosing of the anti-coagulant leading to cases reported to the U.S. Food & Drug Administration (“FDA”). Their analysis begs the question: Is PRADAXA PROGRESS as advertised ?
ISMP’s data revealed that DABIGATRAN was the suspect in 856 reported cases of adverse events in FDA’s MedWatch Adverse Event Reports (AERS). ISMP and FDA recently announced their joint partnership in preventing medication errors and information sharing lending even more support to ISMP’s ability to identify problems and red flags. ISMP analyzed data for the 2nd Quarter of 2011, which includes a snapshot of information following the October 2010 approval and introduction of PRADAXA in the United States. ISMP’s analysis included a “new quarterly total” of 117 reported patient deaths. This is a noteworthy statistic because reports are voluntary and some patient deaths may not have been associated with PRADAXA at the time as widespread reports of international deaths and case reports did not emerge until November 2011 and March 2012 respectively. PRADAXA CASES identified by ISMP include 511 reported cases of hemorrhage, thus reinforcing their concerns that older patients may be overdosing on the new anti-coagulant.
Again, adverse events may be underreported because there is an expectation that bleeding, or hemorrhage, is associated with anti-coagulant treatments. This may lead to underreporting. This theme will be explored through the initiation of PRADAXA CASES in civil court lawsuits involving fatalities, disabling and serious injuries. ISMP’s data identifies PRADAXA as being associated with more adverse events than any other monitored drug. Can the manufacturer, BOEHRINGER INGELHEIM, claim this does not raise a litany of red flags ? In December 2012, FDA articulated calls for post-marketing surveillance of the new anti-coagulant. This was followed by January 2012 label changes discussed here. Sadly, the eager acceptance and use of PRADAXA between October 2010 and January 2012 may have exposed a patient population to higher risks and adverse events that were arguably avoidable.
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