Abstract
Adverse drug reactions (ADRs), unintended and sometimes dangerous effects that a drug may have, are one of the leading causes of morbidity and mortality during medical care. To date, there is no structured machine-readable authoritative source of known ADRs. The United States Food and Drug Administration (FDA) partnered with the National Library of Medicine to create a pilot dataset containing standardised information about known adverse reactions for 200 FDA-approved drugs. The Structured Product Labels (SPLs), the documents FDA uses to exchange information about drugs and other products, were manually annotated for adverse reactions at the mention level to facilitate development and evaluation of text mining tools for extraction of ADRs from all SPLs. The ADRs were then normalised to the Unified Medical Language System (UMLS) and to the Medical Dictionary for Regulatory Activities (MedDRA). We present the curation process and the structure of the publicly available database SPL-ADR-200db containing 5,098 distinct ADRs. The database is available at https://bionlp.nlm.nih.gov/tac2017adversereactions/; the code for preparing and validating the data is available at https://github.com/lhncbc/fda-ars.
Highlights
Background & SummaryA standardised, validated searchable dataset containing information about labelled adverse reactions, i.e., adverse reactions present in Structured Product Labels (SPLs) for Food and Drug Administration (FDA) approved drugs is needed to support such important activities as determining if an adverse reaction reported in clinical trials is caused by the study drug or a concomitant drug; conducting post-market surveillance for previously unobserved reactions; determining whether a drug could be repurposed; or finding patterns to predict drug interactions or other toxicity by pharmacologic class or similar chemical moieties.Several attempts have been made to generate such a resource automatically from SPLs, one of the most comprehensive and authoritative sources of drug information
A standardised, validated searchable dataset containing information about labelled adverse reactions, i.e., adverse reactions present in Structured Product Labels (SPLs) for FDA approved drugs is needed to support such important activities as determining if an adverse reaction reported in clinical trials is caused by the study drug or a concomitant drug; conducting post-market surveillance for previously unobserved reactions; determining whether a drug could be repurposed; or finding patterns to predict drug interactions or other toxicity by pharmacologic class or similar chemical moieties
The adverse drug reactions (ADRs) in Adverse Drug Reaction Classification System (ADReCS) are partially manually mapped to the Unified Medical Language System (UMLS) Metathesaurus and to the Medical Dictionary for Regulatory Activities (MedDRA) MedDRA is a standardised international medical terminology for regulatory communications in the registration, documentation and safety monitoring of medicinal products through all phases of the development cycle: from clinical trials to post-marketing surveillance
Summary
A standardised, validated searchable dataset containing information about labelled adverse reactions, i.e., adverse reactions present in Structured Product Labels (SPLs) for FDA approved drugs is needed to support such important activities as determining if an adverse reaction reported in clinical trials is caused by the study drug or a concomitant drug; conducting post-market surveillance for previously unobserved reactions; determining whether a drug could be repurposed (i.e., for a new indication); or finding patterns to predict drug interactions or other toxicity by pharmacologic class or similar chemical moieties. The widely used SIDER (Side Effect Resource) database combines natural language processing (NLP) and filtering techniques to automatically extract adverse drug reactions (ADRs) from SPLs1. The ADRs in ADReCS are partially manually mapped to the Unified Medical Language System (UMLS) Metathesaurus (https://www.nlm.nih.gov/research/umls/) and to the Medical Dictionary for Regulatory Activities (MedDRA) (https://www.meddra.org/.) MedDRA is a standardised international medical terminology for regulatory communications in the registration, documentation and safety monitoring of medicinal products through all phases of the development cycle: from clinical trials to post-marketing surveillance. To develop such a rigorously validated resource, SPL-ADR-200db, to stimulate development of automated ADR extraction methods, facilitate community-wide evaluations, and provide a gold standard for future research purposes, for example, involving such sources as repoDB4.
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