Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDAs Adverse Event Reporting System (FAERS) and new search tool

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The FDA’s Adverse Event Reporting System (FAERS) is a database that contains adverse event reports, medication error reports and product quality complaints resulting in adverse events that are submitted to the FDA. The database is used as a surveillance tool to help the agency look for new safety concerns that might be related to a marketed product. It is also used to evaluate a manufacturer's compliance with reporting regulations and responding to outside requests for information.

On Thursday, the FDA launched a new dashboard to facilitate access to reports of adverse drug reactions. By making the FAERS database more easily accessible through the dashboard, the agency’s goal is to better inform patients and health care professionals of adverse events reported with drug and biologic products. FAERS can be a valuable tool but it is just one of many data sets that helps inform the agency of possible problems associated with a product.

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. 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.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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