PRADAXA (DABIGATRAN EXTILATE) was approved for use in the United States by the U.S. Food & Drug Administration (“FDA”) in October 2010. In the U.S. it is only approved for use in patients with non-valvular Atrial Fibrillation or AFib. Other indications were considered and denied by the FDA prior to approval. PRADAXA is a blood thinner or anti-coagulant used to minimize the potential for a stroke in patients with AFib. AFib is a heart condition that allows blood to pool in the upper chambers of the heart, thus creating the potential for blood clots that can lead to a stroke.
PRADAXA has been in use in France and other countries for a period of years. During November of 2011 PRADAXA BLOOD case reports emerged that raised proverbial red flags for public health authorities worldwide. Essentially, reports of 260 fatalities from PRADAXA BLOOD were confirmed. REUTERS reported on this story and quoted representatives of the manufacturer, BOEHRINGER INGELHEIM, as potentially underestimating fatal bleeding events. In “BOEHRINGER SAYS ABOUT 50 DEATHS RELATED TO PRADAXA“, published on November 2, 2011, a company spokesman was quoted as stating that “Fifty Cases is a reasonable magnitude that has emerged so far“. This story also implied that this estimation was in keeping with expectations based upon clinical studies that were relied upon to bring the drug to market. However, reports in mid-November 2011 estimated deaths were closer to 260 with 21 in the European Union as of that time.
In reviewing subsequent reports, the fact that PRADAXA does not have a known, or readily available antidote or reversal agent is a common theme in PRADAXA BLOOD cases involving fatalities. PRADAXA is a new blood thinner that was heralded as an alternative, or replacement, for WARFARIN or COUMADIN. WARFARIN or COUMADIN has been available for over fifty years and is both easily monitored and reversible. In fact, it is routinely monitored, and dietary restrictions are necessary to prevent inadvertent reversal. On the other hand, PRADAXA has been promoted as an alternative that requires no monitoring, no dietary restrictions and it has thus been promoted as “progress“. However, what “progress” if any PRADAXA represents is open to debate and speculation given it is so new that many questions about dosing, reversal and side effects remain the subject of growing concern.
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