FDA posts dashboard to track adverse events related to COVID-19 products

March 17, 2021

In response to the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) announced it has launched the FDA Adverse Event Reporting System (FAERS) Public Dashboard for COVID-19 emergency use authorization (EUA) products. The intention of this tool is to expand access of FAERS data to the general public to search for information related to human adverse events reported to the FDA by the pharmaceutical industry, healthcare providers and consumers.

The FAERS dashboard provides weekly updates of adverse event reports submitted to FAERS for drugs and therapeutic biological products used under EUA in COVID-19. After launching the dashboard, click on the COVID-19 EUA link on the home page to open the COVID-19 EUA FAERS Public Dashboard.

While the FAERS dashboard offers stakeholders many more ways of searching for and organizing data on adverse events reported to the FDA for many drug and biologic products, there remain limitations to the data. For example, while FAERS contains reports on a particular drug or biologic, this does not mean that the drug or biologic caused the adverse event. Importantly, the FAERS data by themselves are not an indicator of the safety profile of the drug or biologic. Some additional limitations to note include:

a.    Duplicate and incomplete reports are in the system: There are many instances of duplicative reports and some reports do not contain all the necessary information.

b.     Existence of a report does not establish causation: For any given report, there is no certainty that a suspected drug caused the event.  While consumers and healthcare professionals are encouraged to report adverse events, the event may have been related to the underlying disease being treated, or caused by some other drug being taken concurrently, or occurred for other reasons. The information in these reports reflects only the reporter's observations and opinions.

c.     Information in reports has not been verified: Submission of a report does not mean that the information included in it has been medically confirmed nor it is an admission from the reporter that the drug caused or contributed the event.

d.     Rates of occurrence cannot be established with reports: The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.

e.     Patients should talk to their doctor before stopping or changing how they take their medications. 

Improving data access and transparency are core concepts that drove the development of this FAERS Dashboard. The FDA anticipates that this increased transparency will help to spur the submission of more detailed and complete reports from consumers, health care providers and other members of the public. Complete and detailed reports are immensely helpful to the agency when identifying safety signals and choosing particular products for further scrutiny.

FDA has the release.

More COVID-19 coverage HERE.