Category: Clinical Pharmacology
Purpose: FDA’s Structured Product Labeling (SPL) archive, which stores drug labeling documents submitted by manufacturers, contains labeling information including product indications, dosing recommendations, contraindications, drug interactions, warnings and precautions, adverse reactions, and information for patients to help ensure the safe and effective use of the product. The continual increase in the number of labeling documents and a large amount of data contained in these documents necessitates an advanced bioinformatics tool with powerful drug data management and search capabilities.
Methods: We developed the FDALabel database as a web-based application, containing over 100,000 drug labeling documents, from FDA’s SPL archive. FDALabel allows the public to perform customizable (any combination of sections, document types, and other information), full-text searches of product labeling on a relational Oracle database. A new version of FDALabel (v2.3), available at Amazon Cloud: https://nctr-crs.fda.gov/fdalabel/, was developed to search human prescription drug and biological product labeling and human over-the-counter (OTC) drug labeling.
Results: To demonstrate the FDALabel database’s utility, we selected study cases including a pharmacogenomics study for Precision Medicine and an ADR (Adverse Drug Reaction) study that applied Medical Dictionary for Regulatory Activities (MedDRA) standard terminologies. We identified 261 drugs with 362 drug-biomarker pairs across different therapeutic areas, such as oncology (140), psychiatry (35), and infectious diseases (35). We also found severe ADRs were prevalent in MedDRA System Organ Classes, such as nervous system disorders, psychiatric disorders, and cardiac disorders.
Conclusion: The FDALabel database search tool offers the public, researchers, and regulatory reviewers an efficient and user-friendly means to access and search a large amount of information on drug labeling. An Amazon Cloud version of FDALabel (v 2.3) supports and promotes translational medicine and public health by employing advanced computer technologies to deliver end-users a reliable, effective, and efficient search tool.