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Regulatory Focus™ > News Articles > FDA Launches Searchable Adverse Event Database for Drugs and Biologics

FDA Launches Searchable Adverse Event Database for Drugs and Biologics

Posted 29 September 2017 | By Michael Mezher 

FDA Launches Searchable Adverse Event Database for Drugs and Biologics

The US Food and Drug Administration (FDA) on Wednesday launched a new searchable public dashboard for its adverse event database for drugs and biologics.

Known as FAERS (FDA's Adverse Event Reporting System), the database contains some 14 million adverse event reports submitted to FDA by healthcare professionals, consumers and manufacturers for drugs and biologics. Its immediate release led to questions over certain deaths, whether they were linked to the drug's safety profile and statements qualifying what FAERS can and cannot do.

FAERS does not include reports about vaccines or medical devices, which are recorded in separate databases. While adverse event reporting is voluntary for healthcare providers and consumers, manufacturers are required to submit reports they receive about their products to FDA.

FDA says the dashboard is meant to improve transparency and accessibility to adverse event data by allowing users to more easily run custom searches within FAERS without having to submit a request under the Freedom of Information Act (FOIA).

"Prior to today, the FAERS data were made available on a quarterly basis to the public in a format that was not very easy to sort or search. The user needs to know how to use specific applications and analytic tools that required extensive data management and knowledge of relational databases," said Gerald Dal Pan, director of FDA's Office of Surveillance and Epidemiology.

Specifically, the dashboard allows users to run searches based on a specific drug or biologic, patient age, type of adverse event and the year the adverse event took place and narrow results to a specific timeframe spanning back to 1968. As in the past, FDA says the data available through the dashboard will be updated quarterly.

FDA also says it will provide a tutorial on how to use the dashboard sometime in the next two months.

However, the dashboard does not contain any previously unavailable information. The data accessible via the dashboard is the same as FDA has released to the public on a quarterly basis, just packaged in a more user-friendly interface.

But Dal Pan cautioned that the dashboard has some significant limitations, namely that individual case report narratives, which he says can provide important information about the adverse event, are not available through the dashboard and still must be accessed through a FOIA request.

Dal Pan also pointed out that while FAERS data can be useful for identifying safety signals, it cannot be used to establish causation or the incidence rate for specific adverse events.

"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," he said.

Additionally, FDA notes 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.

FDA, FAERS Dashboard


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