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Adverse Event Reporting System
(AERS)
The Adverse Event Reporting System (AERS) is a computerized information database
designed to support the FDA's post-marketing safety surveillance program for all approved
drug and therapeutic biologic products. The ultimate goal of AERS is to improve the public
health by providing the best available tools for storing and analyzing safety reports.
The FDA receives adverse drug reaction reports from manufacturers as required by
regulation. Health care professionals and consumers send reports voluntarily through the
MedWatch program. These reports become part of a database. The structure of
this database is in compliance with the international safety reporting guidance
(ICH E2B
 )
issued by the International Conference on Harmonisation. The guidance describes the
content and format for the electronic submission of reports from manufacturers.
FDA
codes all reported adverse events using a standardized international terminology,
MedDRA (the Medical Dictionary for Regulatory Activities). Among AERS system features are:
the on-screen review of reports; searching tools; and various output reports.
FDA staff use reports from AERS in conducting postmarketing drug surveillance and compliance
activities and in responding to outside requests for information.
The reports in AERS are evaluated by clinical reviewers in the Center for Drug Evaluation
and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) to detect
safety signals and to monitor drug safety. They form the basis for further epidemiological
studies when appropriate. As a result, the FDA may take regulatory actions to improve
product safety and protect the public health, such as updating a product’s labeling
information, sending out a "Dear Health Care Professional" letter, or
re-evaluating an approval decision.
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Date created: August 7, 2002; Updated: June 6, 2008 |
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