Monitoring a medication or therapeutic biologic product’s safety continues long after clinical trials are complete. This ongoing surveillance, known as pharmacovigilance, relies on the continuous reporting of unexpected medical problems associated with a product. The U.S. Food and Drug Administration (FDA) organizes and analyzes this information to ensure that a product’s risks do not outweigh its benefits in real-world use. The primary tool the FDA uses to track these post-market experiences is the FDA Adverse Event Reporting System (FAERS).
What is the FAERS Database?
FAERS supports the FDA’s post-marketing safety surveillance program for all approved drug and therapeutic biologic products. It replaced the older Adverse Event Reporting System (AERS) in 2012 and serves as a central repository for reports of adverse drug events, medication errors, and product quality issues. The system collects Individual Case Safety Reports (ICSRs), which are structured records of a single adverse experience.
The database adheres to international standards for safety reporting, using terminology from the Medical Dictionary for Regulatory Activities (MedDRA) for coding adverse events. This standardization helps the FDA analyze data efficiently and share information globally. FAERS is a collection of reports, not a definitive study; its primary purpose is to collect data suggesting a potential issue, not to prove that a drug caused an adverse event.
The Process of Adverse Event Reporting
Data flows into FAERS from two main channels: mandatory and voluntary reporting. Pharmaceutical manufacturers and distributors are legally required to submit reports of adverse drug experiences they receive, as codified in regulations such as 21 CFR Part 314 and 600. Manufacturers must submit serious and unexpected adverse events to the FDA within 15 calendar days of receiving the report.
Healthcare professionals (doctors, nurses, and pharmacists), consumers, and patients can voluntarily submit reports directly to the FDA through the MedWatch program. These voluntary reports provide important real-world context for how a product is used across diverse patient populations. Each report details patient demographics, the specific drug product involved, and the adverse event description, including outcomes like hospitalization or death.
The submission process has increasingly shifted to electronic formats, allowing for rapid data entry and processing. Reports are submitted electronically using the international standard known as ICH E2B, which ensures consistency in the data structure. The FDA encourages detailed and complete reports, as the quality of the submitted information directly impacts the agency’s ability to identify safety issues quickly and accurately.
How the FDA Uses FAERS Data for Safety Monitoring
The FDA uses the data in FAERS to detect “safety signals,” which are patterns of adverse events suggesting a potential safety issue not identified in clinical trials. This process involves statistical methods and algorithms to look for disproportionate reporting, comparing the number of reports for a specific drug-event combination to the number of reports expected. While a single, well-documented report can trigger an investigation, a pattern of reports is usually needed to confirm a signal.
Once a potential signal is identified, FDA safety evaluators conduct a thorough review. They examine case details and compare FAERS data with information from other sources, such as large insurance databases or post-marketing studies. Due to the inherent limitations of FAERS data, a reported association does not establish a cause-and-effect relationship between the drug and the event. Reports can be incomplete, unverified, or biased, often receiving a higher initial volume for new products.
If the signal is credible and significant, the FDA may take regulatory actions to protect public health. Actions include updating the product’s labeling to add new warnings or precautions, issuing safety alerts, or requiring the manufacturer to conduct additional post-marketing studies. In rare instances where the risk is severe, the FDA may restrict the drug’s use or request its withdrawal from the market.
Public Access and Necessary Interpretation
To promote transparency, the FDA makes the raw data from the FAERS database available to the public through the FAERS Public Dashboard. This interactive, web-based tool allows consumers and researchers to search and filter adverse event reports by drug name, reaction, and other criteria. The dashboard is updated frequently, allowing for near real-time access to the latest reports the agency has received.
Users must approach the data with caveats regarding its interpretation, which the FDA provides. The data is raw, unverified information submitted by various reporters, and the existence of a report does not confirm the drug caused the event. Furthermore, the database lacks a denominator; it shows how many events were reported, but not the total number of people who took the drug. This makes it impossible to calculate the true incidence or rate of an adverse event. Therefore, FAERS data should inform discussions with a healthcare provider, not serve as a definitive measure of a drug’s safety profile.