Open-Access Adverse Drug Reaction Databases: Applicability for Safety Assessment of the Developed Drugs (Review)

INTRODUCTION. Evaluating safety data on already registered drugs is an important stage in medicine development. Databases (DBs) of adverse drug reactions (ADRs) have been created and maintained by regulatory authorities and individual research groups. The data aggregated in such DBs can help create reference and training datasets for experimental and in silico studies. A preliminary assessment and systematisation of information from these databases can facilitate the selection of DBs relevant to a specific study.

AIM. This study aimed to assess applicability of public ADR databases for safety studies of medicinal products.

DISCUSSION. Eleven public DBs that provide information on ADRs of approved drugs were studied: FAERS, DAEN, MedEffect Canada, EudraVigilance, VigiBase, SIDER, MetaADEDB, ADReCS-Target, T-ARDIS, OnSIDES, and WWAD. The differences between these databases are primarily due to the variety of sources they use: spontaneous reports (FAERS, DAEN, MEDEFFECT, EudraVigilance, VigiBase), patient information leaflets and other official documents (SIDER, OnSIDES, WWAD), scientific publications (ADReCS-Target), and other open-access web resources (MetaADEDB, T-ARDIS). All the reviewed databases can be used for informational support and analysis of drug safety profiles. SIDER, MetaADEDB, ADReCS-Target, OnSIDES, and WWAD are useful in preclinical studies, particularly while developing training sets for in silico methods. Hypotheses for possible ADR mechanisms and search for new drug repurposing vectors can be arranged using ADReCS-Target, WWAD, and T-ARDIS, since these DBs provide additional data on active pharmaceutical substances or target molecules. Using computer-aided methods without thorough hands-on search in the DBs such as ADReCS-Target, T-ARDIS, OnSIDES, and MetaADEDB, limits their applicability in tasks requiring accurately analysed information.

CONCLUSIONS. The DBs reviewed can serve as a valuable tool for addressing a wide range of biomedical issues. To select a DB relevant for a specific study, it is important to consider the underlying principles, since varying sources and annotation methods can affect the reliability of results.

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