Description and Validation of a Novel AI Tool, LabelComp, for the Identification of Adverse Event Changes in FDA Labeling.

Journal: Drug safety
PMID: 39085589

Abstract

INTRODUCTION: The accurate identification and timely updating of adverse reactions in drug labeling are crucial for patient safety and effective drug use. Postmarketing surveillance plays a pivotal role in identifying previously undetected adverse events (AEs) that emerge when a drug is used in broader and more diverse patient populations. However, traditional methods of updating drug labeling with new AE information have been manual, time consuming, and error prone. This paper introduces the LabelComp tool, an innovative artificial intelligence (AI) tool designed to enhance the efficiency and accuracy of postmarketing drug safety surveillance. Utilizing a combination of text analytics and a trained Bidirectional Encoder Representations from Transformers (BERT) model, the LabelComp tool automatically identifies changes in AE terms from updated drug labeling documents.

Authors

  • George A Neyarapally
    Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), FDA, Silver Spring, MD, USA. George.neyarapally@fda.hhs.gov.
  • Leihong Wu
    Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, U.S. Food and Drug Administration, 3900 NCTR Rd, Jefferson, AR, 72079, USA. Leihong.wu@fda.hhs.gov.
  • Joshua Xu
    Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, U.S. Food and Drug Administration, 3900 NCTR Rd, Jefferson, AR, 72079, USA.
  • Esther H Zhou
    Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), FDA, Silver Spring, MD, USA.
  • Oanh Dang
    FDA CDER Office of Surveillance and Epidemiology, Silver Spring, MD, United States.
  • Joann Lee
    Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), FDA, Silver Spring, MD, USA.
  • Dharmang Mehta
    Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), FDA, Silver Spring, MD, USA.
  • Rochelle D Vaughn
    Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), FDA, Silver Spring, MD, USA.
  • Ellen Pinnow
    Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), FDA, Silver Spring, MD, USA.
  • Hong Fang
    b Office of Scientific Coordination , National Center for Toxicological Research, U.S. Food and Drug Administration , Jefferson , AR , USA.

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