The U.S. Food and Drug Administration (FDA) Adverse Event Reporting System, or FAERS, is a database containing reports of adverse events, medication errors, and product quality complaints. Its purpose is to support the FDA’s post-market safety surveillance for drug and therapeutic biologic products. This system functions as a repository for information on potential safety issues that emerge after a product is available to the general public.
Information Contained Within FAERS Reports
An adverse event is any undesirable experience associated with the use of a medical product. Reports in the FAERS database can range from less severe events like headaches to serious outcomes including hospitalization, disability, or even death. The system also tracks medication errors, which are preventable events that may cause or lead to inappropriate medication use or patient harm.
Drug manufacturers are required to submit reports they receive about adverse events. In addition, healthcare professionals, patients, and consumers can voluntarily submit reports. Each report typically contains specific pieces of information, such as the patient’s demographic data like age and sex, the name of the suspected drug or biologic, and a detailed description of the event itself. The report also includes the outcome of the event and the date it occurred.
The Role of FAERS in Drug Safety Surveillance
The FAERS database is a central component of the FDA’s post-market surveillance activities, which monitor the safety of drugs and biologics after they have been approved. Clinical trials, while thorough, involve a relatively small number of people under controlled conditions. FAERS allows the FDA to observe a product’s safety profile as it is used by millions of people with diverse health conditions and who may be taking other medications concurrently.
A primary function of this surveillance is “signal detection.” FDA scientists analyze the submitted reports to identify patterns of adverse events or unexpected side effects that may suggest a new safety concern. These potential safety signals are then investigated further to determine if a real risk exists.
If a safety signal is confirmed, the FDA can take several regulatory actions. These actions may include updating the drug’s labeling with new warnings, issuing public safety communications to inform doctors and patients, or in some cases, requiring the manufacturer to conduct additional studies. In situations where a significant risk is identified, the use of the drug may be restricted or, rarely, the product could be removed from the market.
Inherent Limitations of Reporting Data
While FAERS is a valuable tool, the data it contains has significant limitations that must be understood to avoid misinterpretation. The existence of a report does not establish that the suspected drug caused the adverse event. The event may have been related to the underlying disease being treated, a concurrently used medication, or it may have occurred for other unrelated reasons.
The information in the reports is not always complete or medically verified. The quality and detail of a report depend heavily on the person submitting it. This can lead to submissions that are incomplete, inaccurate, or duplicative. The number of reports for a particular drug can also be influenced by external factors, such as media attention or litigation, which can create reporting biases.
Furthermore, the data cannot be used to calculate how often an adverse event occurs in the population taking a drug. To determine an incidence rate, one would need to know both the total number of people who experienced the event (the numerator) and the total number of people who used the drug (the denominator). FAERS lacks this denominator, making such calculations impossible. The system also experiences underreporting, as it relies on voluntary submissions from many sources, meaning not all adverse events are captured.
Accessing and Interpreting Public Data
The public can access data from the FAERS database through the FAERS Public Dashboard. This interactive, web-based tool allows users to search for information on adverse events reported for human drug and biologic products.
When viewing this data, it is important to remember the system’s limitations. The information is intended to help identify potential safety signals for further evaluation, not to draw firm conclusions about a drug’s safety. The data reflects only the observations and opinions of the person who submitted the report and does not represent a verified causal link between the product and the event.
Therefore, any information found within the FAERS database should be discussed with a qualified healthcare professional. Medical decisions, such as stopping or starting a medication, should never be based solely on information from this reporting system. A healthcare provider can offer the necessary context and guidance to interpret the information correctly and make informed decisions about treatment.