ADVERSE EVENTS – ALERTS & SAFETY SIGNALS
PRADAXA (DABIGATRAN EXTILATE) has been available in the United States since October 2010. The Institute for Safe Medication Practices (ISMP), A Nonprofit Organization Educating the Healthcare Community and Consumers About Safe Medication Practices, conducts a surveillance program that monitors all serious, disabling and fatal adverse drug events (ADEs) reported to the U.S. Food & Drug Aministration (FDA) by manufacturers and the public. Such reports are communicated by the MedWatch reporting program. The ISMP publishes their analysis in a trademarked publication known as QuarterWatch.
ISMP, through QuarterWatch, has reported that PRADAXA (DABIGATRAN EXTILATE) literally generated hundreds of adverse event reports for the first quarter of 2011. As summarized by ISMP, in QuarterWatch for the 1st Quarter of 2011, PRADAXA BLOOD was associated with cases of death, permanent disability, and hospitalization. These cases involved hemorrhage and hemorrhagic stroke. Reports of hemorrhagic stroke are particularly noteworthy because PRADAXA is heavily advertised as a means to reduce the risk of ischemic strokes as illustrated above and on-line at www.PRADAXA.com.
While all blood thinners, or anticoagulants, present an increased risk of bleeding or hemorrhage, the effects of PRADAXA (DABIGATRANE EXTILATE) are not readily reversed. This fact, along with little scientific evidence being available regarding how to reverse PRADAXA BLOOD in the event of unplanned bleeding or a medical emergency, arguably raise risks to patients in an unprecedented fashion. Other available blood thinners, like WARFARIN or COUMADIN, which PRADAXA is often contrasted with, do in fact have over 50 years of use in clinical practice and a scientific pathway for reversal.
ISMP’s QuarterWatch reported that it contacted the manufacturer, BOEHRINGER INGELHEIM, and that they “attributed the volume of reports” to them and FDA to the drug’s rapid acceptance and active sales force with established physician relationship. However, promotional materials and public relations campaigns have repeatedly heralded the idea that “PRADAXA is progress” because it requires no blood monitoring. These promotional efforts, coupled with the lack of a quick reversal agent are central issues in pending investigations and lawsuits over PRADAXA BLOOD.
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