The May 31, 2012, QuarterWatch, Monitoring FDA MedWatch Reports, released by the ISMP (Institute for Safe Medication Practices) has confirmed that PRADAXA (DABIGATRAN ETEXILATE) lead all drugs in adverse event reports in 2011 with a total of 3,781 serious adverse events reported by both the manufacturer and direct reports. More information appears here at PRADAXA CASES.
PRADAXA (DABIGATRAN EXTILATE) has been heavily promoted and advertised in mass media outlets, including the Internet, TV and print. This promotional video was posted to YouTube in November 2011 as reports were just emerging of over 260 deaths world wide. At the time, reports appeared to indicate that the number of anticipated deaths may have been underestimated by representatives of the manufacturer, BOEHRINGER INGELHEIM. Since that time, the U.S. Food & Drug Administration has publicly noted that it is monitoring post-approval (October 2010) reports of bleeding associated with PRADAXA CASES.
PRADAXA (DABIGATRAN EXTILATE) is a blood thinner that was approved for use in the United States in October of 2010 by the U.S. Food & Drug Administration. All blood thinners carry risks of potential side effects and bleeding. However, PRADAXA BLOOD is not easily, or quickly reversible and thus does not have an antidote that has been proven over time. PRADAXA (DABIGATRAN EXTILATE) is new to the pharmaceutical market and gained celebrated status as “the newest” blood thinner for patients in need of anticoagulant therapy. It also gained popularity because it was advertised as requiring little maintenance or upkeep. Additionally, PRADAXA was promoted as not requiring patients to follow dietary restrictions, like WARFARIN, and the related costs of monitoring.
In November 2011, reports emerged of 260 PRADAXA CASES resulting in deaths. Internationally, health authorities raised concerns over the lack of a quick antidote for the onset of unexpected, or bleeding in emergent circumstances.
Most recently, in March 2012, a PRADAXA CASE REPORT emerged that chronicled the death of an 82 year old man in Utah following a fall. Within hours, a small bleed in his brain became uncontrollable and contributed to, or caused his death.
Gabriel F. Zambrano, P.A., is the author and sponsor of this site. Gabriel F. Zambrano, P.A., has initiated investigations of PRADAXA CASES following reports to his office of death(s) involving PRADAXA BLOOD or PRADAXA BLEEDS.