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November 25, 2020 09:00pm
By Sara Karlovitch, Assistant Editor
Officials with the FDA launched a new search that enables better access to information on adverse drug events associated with drug and biologic products through the FDAâ€™s Adverse Event Reporting System (FAERS).
Officials with the FDA launched a new search that enables better access to information on adverse drug events associated with drug and biologic products through the FDA’s Adverse Event Reporting System (FAERS).
The new dashboard enables users to search for and organize data by criteria such as drug/biological product, age of the patient, type of adverse event, year the adverse event occurred, or within a specific timeframe.
The FDA uses FAERS for surveillance, such as looking for new safety concerns that might be related to a marketed product, evaluating a manufacturer's compliance with reporting regulations and responding to outside requests for information. The reports in FAERS are evaluated by clinical reviewers in the FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research to monitor the safety of products after they are marketed. If a potential safety concern is identified in FAERS, further evaluation is performed.
While the FAERS dashboard now 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 adverse events associated with a particular drug or biologic, this does not mean that the drug or biologic caused the adverse event, FDA officials noted in a press release. Importantly, the FAERS data by themselves are not an indicator of the safety profile of the drug or biologic. Patients should still talk to their health care professional if they have any concerns regarding their medications.
"Tools like the FDA Adverse Event Reporting System are critical to the FDA’s ability to help ensure the greatest level of transparency and help patients and providers make safe use of drug and biologic products after they are approved by the FDA," FDA Commissioner Scott Gottlieb, MD said in the press release. "The FDA is committed to fully informing patients and providers of adverse events reported with medical products and this enhanced portal now provides patients, doctors and others with easier access to the data they are interested in."
FDA improves access to reports of adverse drug reactions [news release]. Gaithersburg, MD. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm578105.htm. Accessed September 29, 2017.