The centralized computerized information database for post-marketing drug safety surveillance is the FDA Adverse Event Reporting System (FAERS), which is currently growing by approximately 800,000 new cases per year. In 1993, FAERS (then referred to as AERS) launched with a simple, and worthy, goal: facilitate the reporting of post-approval ADEs. For healthcare professionals and consumers reporting is voluntary, but drug manufacturers must report all known ADEs to the FDA. In 2007, in order to enhance post-approval drug safety analysis even further, the FDA began to require drug companies to enact Risk Evaluation and Mitigation Strategies (REMS) to better manage, track, and report ADEs.


Related Read: Post Approval Adverse Events ... What's the Real World Impact? [INFOGRAPHIC]




FDA professionals and pharmacovigilance experts routinely look to FAERS data as both a guide to, and signal generator of, drug safety issues. Both groups employ a wide array of sophisticated data mining and signal detection techniques (for recent reviews please see Tatonetti and Harpaz). FDA uses such analyses to issue warnings, mandate label changes, and remove drugs from the US market after the incidence, or severity, of their side effects is determined to significantly differ from what clinical trial results previously suggested.

FAERS, and other similar spontaneous reporting systems maintained by governmental and international organizations (examples: Australia’s “Therapeutic Goods Administration,” Canada’s “Vigilance Adverse Reaction Online Database,” Europe’s “EudraVigilance,” Japan’s “Pharmaceuticals and Medical Devices Agency,” The United Kingdom’s “Yellow Card Scheme,” and The World Health Organization’s “VigiBase”) are currently a main resource for identifying post-marketing drug safety concerns.

Unfortunately, FAERS has remained inaccessible to healthcare professionals. In fact, publicly available FAERS information can only be obtained through complicated data downloads by individuals familiar with relational databases (as FDA states “a simple search of FAERS data cannot be performed with these files by persons who are not familiar with creation of relational databases”) or burdensome Freedom of Information Act requests.

Learn more on post-market side effects in our comprehensive guide to FAERS. 


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Jim Davis

Jim Davis

Executive Vice President

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Topics: FDA, FAERS

Jim Davis

Written by Jim Davis

As Executive Vice President, Jim is responsible for the commercialization strategy for Advera Health Analytics.