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Topic: Medication
Publication Type: Safety and Quality Alerts and Advisories
Single or Multiple Incident: Multiple
Date: 10/20/2011 12:00:00 AM
Country: Australia
Organization: South Australia Department of Health (Australia)

This safety notice addresses patient safety incidents associated with the use of a high alert drug, Dabigatran (Pradaxa®), an oral anticoagulant, recently approved for use in patients with non-valvular atrial fibrillation and at least one risk factor for stroke. Safety alerts have been issued in Australia and internationally following increased reports of bleeding-related adverse events. Many of the serious patient safety incidents were related to gastrointestinal bleeding and occurred in patients over 75 years of age. Intracranial bleeding has also been reported. The safety notice provides several specific considerations for management of patients taking dabigatran and those with bleeding complications.

Additional Details

Medication/Gas/Fluid:
oral anticoagulant, dabigatran (Pradaxa®), warfarin
Medication/IV List:
antithrombotic agents (anticoagulants)


Dabigatran:bleeding-related adverse events