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More eyeballs on AERS

Nature Biotechnology volume 27, pages 601–602 (2009)Cite this article

To the Editor:

Your recent editorial 'Making a difference'1 advocated “the immediate overhaul of the FDA's antiquated Adverse Event Reporting System (AERS)” for drugs. As described1, the modern version of AERS is thought to be the largest database of its kind, consisting of ∼3 million reports of adverse drug reactions and has the potential to serve as a useful data source in pharmacovigilance efforts. Even so, as noted by the editorial, current deficiencies in AERS hinder its potential utility1. These deficiencies include the lag time between collection and release of AERS data (typically 3 to 4 months after the end of each quarter) and the form in which the data are released—ASCII or SGML files—as these files are not readily amenable to query or analysis.

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Figure 1: Scatter plot showing PPRs of adverse events reported for cerivastatin within AERS compared with all AEs reported for all other drugs.

References

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  1. FDAble, LLC, Glastonbury, Connecticut, USA

    Leslie A Pratt & Paul N Danese

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  1. Leslie A Pratt
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  2. Paul N Danese
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L.A.P. and P.N.D. are founders of the organization providing the search-engine FDAble LLC.

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Pratt, L., Danese, P. More eyeballs on AERS. Nat Biotechnol 27, 601–602 (2009). https://doi.org/10.1038/nbt0709-601

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