December 13, 2017

Research Tools: FDA Improves Access to Reports of Adverse Drug Reactions

From the Food and Drug Administration:

[Late last week] the U.S. Food and Drug Administration launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System (FAERS). The tool is designed to make it easier for consumers, providers, and researchers to access this information.

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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. In addition to making it easier for consumers to search for adverse events reported with drug or biologic products, the FDA hopes the increased transparency will spur the submission of more detailed and complete reports from consumers, health care professionals and others, by making it easier for people to see other reports that the FDA receives, and search the database for similar observations.

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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.

In addition to the FAERS database for drugs and biologics, the agency has adverse event reporting programs and databases for foods, dietary supplements, and cosmetics (CFSAN Adverse Event Reporting System, or “CAERS”), medical devices (Manufacturer and User Facility Device Experience, or “MAUDE”) and vaccines (Vaccine Adverse Event Reporting System, or “VAERS” that the FDA co-manages with the Centers for Disease Control and Prevention).

Read the Complete Announcement

Direct to FDA’s Adverse Event Reporting System (FAERS)

Gary Price About Gary Price

Gary Price (gprice@mediasourceinc.com) is a librarian, writer, consultant, and frequent conference speaker based in the Washington D.C. metro area. Before launching INFOdocket, Price and Shirl Kennedy were the founders and senior editors at ResourceShelf and DocuTicker for 10 years. From 2006-2009 he was Director of Online Information Services at Ask.com, and is currently a contributing editor at Search Engine Land.

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