FDA Launches Public Adverse Event Monitoring Dashboard for COVID-19 EUA Products

March 18, 2021

The US Food and Drug Administration (FDA) has launched an adverse event reporting system dashboard, available to the public, for coronavirus disease 2019 (COVID-19) products that have been issued emergency use authorisation (EUA) by the FDA.

The interactive web-based tool will allow for the querying of adverse event data in a user-friendly fashion. The intention of this tool is to expand access of the FDA Adverse Event Reporting System (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 COVID-19 EUA FAERS Public 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 FAERS Public Dashboard, click on the COVID-19 EUA link on the home page to open the COVID-19 EUA FAERS Public Dashboard.

The FAERS data by themselves are not an indicator of the safety profile of the drug or biologic. In addition, the 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. 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.

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 the COVID-19 EUA 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.

Reference: https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-repor...

SOURCE: US Food and Drug Administration