The U.S. Food and Drug Administration (FDA) collects information about adverse reactions to prescription drugs and medical devices. This information is collected in the FAERS, the FDA Adverse Event Reporting System. Now, the agency is making it easier for the public to search and use FAERS to get information about potential risks of devices and drugs.
What is FAERS?
The Adverse Event Reporting System is a database collecting reports of adverse reactions to drugs or devices, medication errors, and complaints about quality. This information is submitted to the FDA by healthcare providers, manufacturers, and consumers and is kept in the database. The FDA uses the database to conduct ongoing, post-marketing safety surveillance. The reports are evaluated and if a safety concern is found the FDA can follow up with further studies. FAERS includes a huge amount of information, with reports dating back to 1969, and this can make it difficult to access useful information from the database.
The FAERS Public Dashboard
Until recently, getting information from the database was possible but challenging and complicated. With a new search tool, the FDA has now made it easier for consumers, researchers, and others to get information about medicines and devices. The FDA calls the new search tool the FAERS Public Dashboard. Anyone can access it and use it to search adverse event reports by drug name, patient age, adverse event type, year of event, and other factors.
The purpose of the dashboard is to make it easier for the public to access FAERS information, but the FDA also hopes the search tool will have a ripple effect. The hope is that the increase in transparency will lead to better, more complete reports being submitted to the database. This in turn will make it easier to find safety issues and to make all drugs and devices safer for consumers.
Adverse Events Do Not Necessarily Mean a Drug is Unsafe
While releasing this new tool to make access to adverse events easier, the FDA also warns the public not to misread the information. The agency is emphasizing the fact that reported adverse events and drug side effects do not mean a drug is always unsafe for everyone. There is not always a cause and effect relationship between a medication and a side effect and the information in the reporting system has not necessarily been verified. The FDA also warns that patients should never stop taking a drug without talking to the prescribing doctor first.
The FDA wants to make its process and information about drugs, devices, and side effects more transparent. The Public Dashboard for FAERS is a step in the right direction for increasing transparency and giving people greater access to information about the drugs and devices they use. It may also prove to be an important tool in forcing reporters to include more detail and useful information when adding to FAERS. How much the new tool is used and the effect it will have on health care and safety remains to be seen.