What is a Literature Reference in FAERS?
Literature References were added to the FAERS database in Q3 of 2014. They are added to FAERS case reports when either the patient in the FAERS case was one of the patients in the published literature referenced OR where the published literature referenced discusses the AEs and Drugs discussed in the case report.
As shown in the examples section, there are a few varieties of literature references that show up in FAERS. The most common type is where the topic of the published literature is:One or more patients experienced an adverse event after taking a drug or class of drugs.In these lit refs, the patient in the FAERS case report may or may not have been one of the patients in the referenced literature. (Examples 1, 2, and 3 below.)
The second main variety is an observational or clinical study where the patient in the FAERS Case Report was also one of the patients in the literature referenced. When these studies are referenced, a link to clinicaltrials.gov will be added on the Drug/AE analysis page if the study was registered there. (Example 4 below.)
The third variety is where the case report says the source of the case report was “Literature Reference”.In all of these case reports, there is never a link to the actual referenced literature.These are very rare and only 6 cases reports like this were reported in Q1 2016. (Example 5 below.)
How to Access Literature References
From a drug's Adverse Event tab, users can access a column in the right of the data table that says "Literature Reference." The number shown in that column reflects the number of Literature References for that drug/adverse event pair across all of the case reports submitted to FDA. Click on a Literature Reference number or an Adverse Event term in this table to be taken to the Drug/Adverse Event Analysis. There users will find summary info and links to the listed Literature References.
Examples
Single Case – Drug Associated with Adverse Event (Lit. Ref. listed matches the FAERS Case Report)
FAERS case report in Evidex:
Literature Reference listed in above FAERS case report - 23 year old woman - matching patients:
Multiple Cases - Multiple accounts of adverse event showing in literature (Lit. Ref. listed is different than FAERS Case Report)
FAERS report in Evidex - initial FDA date 3/15/16: http://www.adverahealth.com/explorer/#/caseprofile/detail/121792011
Literature Reference listed in above FAERS case report - publication from 2014 - different patient: https://www.ncbi.nlm.nih.gov/pubmed/25323231
Multiple Cases - One account of a drug associated with an adverse event in literature (Lit. Ref. listed matches FAERS case report)
FAERS report in Evidex - patient on Avonex for 7 years: http://www.adverahealth.com/explorer/#/caseprofile/detail/118135311
Literature Reference listed in FAERS case -matching cases:https://www.ncbi.nlm.nih.gov/pubmed/26564996
Observational Trial – Efficacy of one treatment versus other (FAERS Case comes from study listed)
Case reported in FAERS April 2015: http://www.adverahealth.com/explorer/#/caseprofile/detail/110028351
Literature Reference listed in FAERS case - published 12/2015: https://www.ncbi.nlm.nih.gov/pubmed/26075320
Cases reported to FAERS because they were found in published literature - "Report Source" lists a reference in published literature.