Identification and Validation of Novel Signals of Drugs Using the FAERS Database
Sweta Roy, Vipin Bhati, Ruchika Sharma, Deepti Pandita, Anoop Kumar · 2024
FDA Adverse Event Reporting System (FAERS) is an important data mining tool that provides adverse drug reaction data. This study outlines the exploration of novel adverse drug reactions through the identification and validation process using the FAERS database. In this chapter, we have discussed the two case studies: one is the identification of myasthenia gravis as a novel signal associated with HMG-CoA inhibitors and another study has DRESS as a novel signal associated with propionic acid derivatives. These studies employ data mining approaches to extract potential signals, followed by different validation methods to ensure reliability.