FDA improves access to Adverse Events database

The FDA recently launched a new search tool to make the Adverse Events (AEs) for drug and biological products more accessible. The system known as FAERS (FDA’s Adverse Event Reporting System) encompasses around 14 million AEs submitted to the FDA by drug manufacturers, other healthcare professionals and consumers.

In an aim to improve transparency by the FDA, the new dashboard allows users to tailor their searches and organise data by criteria such as type of adverse event, age of the patient, drug/biological product, year the adverse event occurred or within a specific timeframe (spanning back to 1969).

The data available will be updated on a quarterly basis. The FDA are likely to conduct a tutorial on how to use the dashboard within the next two months.

The FDA hope that the increased transparency will provide a better understanding of the data and lead to the submission of more comprehensive reports.

Whilst the data already available has become more accessible there is no new information available to the user, resulting in the some limitations as explained by Dal Pan, Director of the Office of Surveillance and Epidemiology: “While FAERS contains reports on a particular drug, this does not mean that the drug caused the adverse event. Importantly, the FAERS data by themselves are not an indicator of the safety profile of the drug,” which means FAERS data can be useful for identifying safety signals, however it cannot be used to establish the incidence rate for specific adverse events or causation.

Important information about an AE which can be found in an individual case report narrative must still be accessed through a Freedom of Information Act (FOIA) as this information is not available through the dashboard.

The FDA has emphasized that there are a number of data quality issues that must be considered when looking at FAERS data, including the potential for duplicate, incomplete or inaccurate reports.

The full press release can be found here.