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Systemic Barriers and Potential Concerns from Reporting Serious Adverse Drug Reactions
Matthew A Taylor1, Ashley C Godwin1, Shamia Hoque1
1SONAR (Southern Network on Adverse Reactions) Program, University of South Carolina Colleges of Pharmacy and Engineering, Columbia, SC, 29208, USA.
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.
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