QuarterWatch, Monitoring FDA MedWatch Reports, is published by the Institute for Safe Medication Practices. QuarterWatch is a trademarked and independent publication that monitors all domestic, serious adverse drug events reported to the U.S. Food & Drug Administration (“FDA”). An Executive Summary, dated January 12, 2012, examined available data from the FDA, Adverse Reporting System, (AERS), and related MedWatch reports for signals and findings regarding PRADAXA (DABIGATRAN EXTILATE). QuarterWatch noted 500 reports of fatal, disabling or other severe hemorrhages or PRADAXA CASES. QuarterWatch defines the term “signal” as evidence of sufficient weight to justify an alert to the public and scientific community, warranting further investigation. It also reported the manufacturer was continuing to work with the FDA to provider “better guidance to physicians about treating the oldest patients”. Their analysis suggested that elderly patients were at risk for severe bleeds resulting in harm not benefit to this undefined population. The authors of QuarterWatch suggested that review of PRADAXA (DABIGATRAN EXTILATE) and adverse effects on high risk patients need to be a national priority.
Notably, QuarterWatch also questioned a potential relationship between PRADAXA CASES, dosing and the age of patients. Another trend suggests that while prescriptions surged so did reports of serious adverse drug events. As a result, in the 1st Quarter of 2011, QuarterWatch, summarized findings as revealing data that justified their concerns.
The sponsor of this site, Gabriel F. Zambrano, P.A., is investigating PRADAXA CASES that include deaths, permanent disability, hospitalization, gastrointestinal hemorrhaging, hemorrhagic stroke and heart attacks. FREE CASE EVALUATIONS are available through use of the contact form below.