Systemic Barriers and Potential Concerns from Reporting Serious Adverse Drug Reactions

Matthew A Taylor; Ashley C Godwin; Shamia Hoque; Charles L Bennett

doi:10.1007/978-3-031-04402-1_5

Systemic Barriers and Potential Concerns from Reporting Serious Adverse Drug Reactions

Cancer Treat Res. 2022:184:75-85. doi: 10.1007/978-3-031-04402-1_5.

Authors

Matthew A Taylor¹, Ashley C Godwin¹, Shamia Hoque¹, Charles L Bennett²

Affiliations

¹ SONAR (Southern Network on Adverse Reactions) Program, University of South Carolina Colleges of Pharmacy and Engineering, Columbia, SC, 29208, USA.
² SONAR (Southern Network on Adverse Reactions) Program, University of South Carolina Colleges of Pharmacy and Engineering, Columbia, SC, 29208, USA. bennettc@cop.sc.edu.

PMID: 36449189
DOI: 10.1007/978-3-031-04402-1_5

Abstract

About 1-10% of all serious adverse drug reactions (sADRs) are reported to the Food and Drug Administration (FDA) ( Moore T, Bennett C. Underreporting of Hemorrhagic and Thrombotic Complications of Pharmaceuticals to the U.S. Food and Drug Administration: Empirical Findings for Warfarin, Clopidogrel, Ticlopidine, and Thalidomide from the Southern Network on Adverse Reactions (SONAR). Semin Thromb Hemost. 2012;38(08):905-907. https://doi.org/10.1055/s-0032-1328890 ). Prevailing opinion suggests that low reporting rates reflect time constraints.

MeSH terms

Clopidogrel
Drug-Related Side Effects and Adverse Reactions*
Humans
Immunotherapy*
Thalidomide
Ticlopidine
United States

Substances

Clopidogrel
Thalidomide
Ticlopidine