Aug 10, 2016

The Powers and Perils of Post-Marketing Data Analysis: Quantification and Mitigation of Biases in the FDA Adverse Event Reporting System

BioRxiv : the Preprint Server for Biology
Mateusz MaciejewskiBrian K Shoichet


The Food and Drug Administration Adverse Event Reporting System (FAERS) is the primary source for postmarketing pharmacovigilance. Though potentially highly useful, the database reflects reporting biases, stimulated reporting, and suffers from lack of standardization and the use of multiple drug synonyms. These biases can suggest adverse drug reactions (ADRs) where none exist, and can obscure others that do exist. To decrease the noise in FAERS, and to reinforce important associations, we mapped over 750,000 drug identifiers in FAERS to the normalized chemical structures of their ingredients. This illuminated associations that would not otherwise be apparent, and also allowed a time-resolved analysis of ADR reporting. It also revealed similarities between drugs and adverse events across therapeutic classes, enabling unbiased classification of adverse events, indications, and drugs with similar clinical profiles. For instance, comparison of two selective cyclooxygenase-2 inhibitors, celecoxib and rofecoxib finds distinctive FAERS profiles after time-resolved analysis. We also investigated key idiosyncrasies, such as confusion between drug indications and drug ADRs, which can tar a drug treating a life-threatening disease, like t...Continue Reading

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Mentioned in this Paper

United States Food and Drug Administration
Vascular Endothelial Growth Factor Receptor
VEGFA gene
Vascular Endothelial Growth Factors
Adverse Event

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