Curious practitioners will enjoy exploring the Database of Adverse Event Notifications (DAEN) launched by the TGA this week.
The 251,000 adverse drug reactions reported to the TGA since 1971 have been entered into the DAEN, an on-line database which enables analysis of both individual case reports and summaries grouped by number, affected organs, reaction, and mortality. The database uses internationally agreed terminology defined in the Medical Dictionary for Regulatory Activities (MedDRA).
DAEN is easy to use, with the selection screen needing only the brand or generic drug name and the date range, but with an option to narrow the report to particular organs. The results provide a summary of all reactions, a page detailing each event, and a numerical compilation of all events grouped and sorted according to your preference.
A quick check on dabigatran for 2012 showed 229 reports, most involving only the one drug, where 70 were related to gastrointestinal disorders, and that 3 of the 24 patients with gastrointestinal haemorrhage died.
The value and power of the data available might just encourage an increase in reporting to the Australian Adverse Drug Reaction Reporting System any problems with medicines whether a deficiency, defect, or adverse event.
The final word of caution is to remember that the DAEN can only be as complete as those reports submitted. It does not explore the efficacy or safety of medicines, and can’t determine what actually caused the adverse event.
Patients should always discuss any concerns with their health practitioner.