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AERS: a useful tool for FDA

Excerpts from (FDA) CDER news 4/6/09. AERS, the Adverse Event Reporting System,contains over 4 million reports of adverse events and reflects data from 1969 to the present. Data from AERS are presented here (1) as summary statistics covering data received over the last 10 years. (updated 4/6/09)

Reports Received and Reports Entered into AERS by Year;
Domestic and Foreign Reports by Year;
Reporting by Healthcare Providers and Consumers by Year;
Patient Outcomes by Year. Serious outcomes include death, hospitalization, life-threatening, disability, congenital anomaly and/or other serious outcome.

The structure of AERS is in compliance with the international safety reporting guidance ICH E2B (2) issued by the International Conference on Harmonisation. Adverse events in AERS are coded to terms in the Medical Dictionary for Regulatory Activities terminology (MedDRA).
The # of domestic/foreign reports in AERS for 2008:
Domestic Foreign Unknown Total
287,028 149,033 5,316 441,367.
Not all of the reports that FDA receives for drug and therapeutic biologic products are entered into the AERS database. At the present time, they are entering reports of the following types:
-Reports submitted directly to FDA (not submitted through manufacturers);
-Reports submitted on 3500A (or CIOMS) forms by manufacturers that are categorized as: 15-day reports , serious Periodic reports, or nonserious Periodic reports for new molecular entity (NME) products within the first 3 years following FDA approval;
Reports submitted electronically by manufacturers regardless of category.
What is AERS Patient Outcomes data-see 21 CFR 310.305, 314.80, 314.98, 600.80 and Forms FDA 3500 and 3500A (the MedWatch forms).
AERS is a useful tool for FDA which uses it for activities such as looking for new safety concerns that might be related to a marketed product, evaluating a manufacturer's compliance to reporting regulations and responding to outside requests for information. The reports in AERS are evaluated by clinical reviewers in CDER and CBER to monitor the safety of products after they are approved by FDA. If a potential safety concern is identified in AERS, further evaluation might include epidemiological studies. Based on an evaluation of the potential safety concern, FDA may take regulatory action(s) to improve product safety and protect the public health, such as updating a product’s labeling information, restricting the use of the drug, communicating new safety information to the public, or, in rare cases, removing a product from the market.(3)

AERS data do have limitations.
-there is no certainty that the reported event was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event.
-FDA does not receive all adverse event reports that occur with a product. Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event. Therefore, AERS cannot be used to calculate the incidence of an adverse event in the U.S. population.

(2) http://www.ich.org/cache/compo/475-272-1.html#E2B http://www.fda.gov/cder/guidance/6675fnl.pdf latest Q’ and A’ FDA Guidance , including electronic reporting of AERs. The Implementation Working Group was discontinued 11/04, so all tech. q’s now addressed to Regional Regulatory authorities. http://www.ich.org/LOB/media/MEDIA1475.pdf document history

Comments (1)

Leslie Pratt:

Joan, there is a public search engine for the AERS database (as well as the VAERS [vaccine] database).

It may be of use to you and your colleagues.

The link below will show a search of AERS reports for baycol (a 'statin' that has since been withdrawn from the US Market) where myopathy (muscle wasting) was noted:


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