Authors:
Charles L Bennett 1 2 3, Shamia Hoque 4, Nancy Olivieri 5, Matthew A Taylor 6, David Aboulafia 7, Courtney Lubaczewski 8, Andrew C Bennett 3, Jay Vemula 8, Benjamin Schooley 4, Bartlett J Witherspoon 3, Ashley C Godwin 2 3, Paul S Ray 3, Paul R Yarnold 3, Henry C Ausdenmoore 1 2 4 4 8 6 9 10 11 12 13 14 15 16 17 7 18 19, Marc Fishman 3, Georgne Herring 8, Anne Ventrone 8, Juan Aldaco 1, William J Hrushesky 3, John Restaino 2 3, Henrik S Thomsen 15, Paul R Yarnold 3, Robert Marx 9, Cesar Migliorati 19, Salvatore Ruggiero 18, Chadi Nabhan 3 16, Kenneth R Carson 13, June M McKoy 12, Y Tony Yang 20, Martin W Schoen 14, Kevin Knopf 3 17, Linda Martin 3, Oliver Sartor 11, Steven Rosen 1, William K Smith 10
Background
Adverse drug/device reactions (ADRs) can result in severe patient harm. We define very serious ADRs as being associated with severe toxicity, as measured on the Common Toxicity Criteria Adverse Events (CTCAE)) scale, following use of drugs or devices with large sales, large financial settlements, and large numbers of injured persons. We report on impacts on patients, clinicians, and manufacturers following very serious ADR reporting.
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