Evaluation of serious adverse drug reactions

A Proactive Pharmacovigilance Program (RADAR) vs safety activities conducted by the Food and Drug Administration and pharmaceutical manufacturers

Charles L. Bennett, Jonathan R. Nebeker, Paul R. Yarnold, Cara C. Tigue, David Dorr, June M. McKoy, Beatrice J. Edwards, John F. Hurdle, Dennis P. West, Denys T. Lau, Cara Angelotta, Sigmund A. Weitzman, Steven M. Belknap, Benjamin Djulbegovic, Martin S. Tallman, Timothy M. Kuzel, Al B. Benson, Andrew Evens, Steven M. Trifilio, D. Mark Courtney & 1 others Dennis W. Raisch

Research output: Contribution to journalArticle

38 Citations (Scopus)

Abstract

Background: The Food and Drug Administration (FDA) and pharmaceutical manufacturers conduct most postmarketing pharmaceutical safety investigations. These efforts are frequently based on data mining of databases. In 1998, investigators initiated the Research on Adverse Drug events And Reports (RADAR) project to investigate reports of serious adverse drug reactions (ADRs) and prospectively obtain information on these cases. We compare safety efforts for evaluating serious ADRs conducted by the FDA and pharmaceutical manufacturers vs the RADAR project. Methods: We evaluated the completeness of serious ADR descriptions in the FDA and RADAR databases and the comprehensiveness of notifications disseminated by pharmaceutical manufacturers and the RADAR investigators. A serious ADR was defined as an event that led to death or required intensive therapies to reverse. Results: The RADAR investigators evaluated 16 serious ADRs. Compared with descriptions of these ADRs in FDA databases (2296 reports), reports in RADAR databases (472 reports) had a 2-fold higher rate of including information on history and physical examination (92% vs 45%; P

Original languageEnglish (US)
Pages (from-to)1041-1049
Number of pages9
JournalArchives of Internal Medicine
Volume167
Issue number10
DOIs
StatePublished - May 28 2007

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Pharmacovigilance
United States Food and Drug Administration
Drug-Related Side Effects and Adverse Reactions
Safety
Research
Pharmaceutical Preparations
Research Personnel
Databases
Pharmaceutical Databases
Data Mining
Physical Examination

ASJC Scopus subject areas

  • Internal Medicine

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Evaluation of serious adverse drug reactions : A Proactive Pharmacovigilance Program (RADAR) vs safety activities conducted by the Food and Drug Administration and pharmaceutical manufacturers. / Bennett, Charles L.; Nebeker, Jonathan R.; Yarnold, Paul R.; Tigue, Cara C.; Dorr, David; McKoy, June M.; Edwards, Beatrice J.; Hurdle, John F.; West, Dennis P.; Lau, Denys T.; Angelotta, Cara; Weitzman, Sigmund A.; Belknap, Steven M.; Djulbegovic, Benjamin; Tallman, Martin S.; Kuzel, Timothy M.; Benson, Al B.; Evens, Andrew; Trifilio, Steven M.; Courtney, D. Mark; Raisch, Dennis W.

In: Archives of Internal Medicine, Vol. 167, No. 10, 28.05.2007, p. 1041-1049.

Research output: Contribution to journalArticle

Bennett, CL, Nebeker, JR, Yarnold, PR, Tigue, CC, Dorr, D, McKoy, JM, Edwards, BJ, Hurdle, JF, West, DP, Lau, DT, Angelotta, C, Weitzman, SA, Belknap, SM, Djulbegovic, B, Tallman, MS, Kuzel, TM, Benson, AB, Evens, A, Trifilio, SM, Courtney, DM & Raisch, DW 2007, 'Evaluation of serious adverse drug reactions: A Proactive Pharmacovigilance Program (RADAR) vs safety activities conducted by the Food and Drug Administration and pharmaceutical manufacturers', Archives of Internal Medicine, vol. 167, no. 10, pp. 1041-1049. https://doi.org/10.1001/archinte.167.10.1041
Bennett, Charles L. ; Nebeker, Jonathan R. ; Yarnold, Paul R. ; Tigue, Cara C. ; Dorr, David ; McKoy, June M. ; Edwards, Beatrice J. ; Hurdle, John F. ; West, Dennis P. ; Lau, Denys T. ; Angelotta, Cara ; Weitzman, Sigmund A. ; Belknap, Steven M. ; Djulbegovic, Benjamin ; Tallman, Martin S. ; Kuzel, Timothy M. ; Benson, Al B. ; Evens, Andrew ; Trifilio, Steven M. ; Courtney, D. Mark ; Raisch, Dennis W. / Evaluation of serious adverse drug reactions : A Proactive Pharmacovigilance Program (RADAR) vs safety activities conducted by the Food and Drug Administration and pharmaceutical manufacturers. In: Archives of Internal Medicine. 2007 ; Vol. 167, No. 10. pp. 1041-1049.
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AU - Yarnold, Paul R.

AU - Tigue, Cara C.

AU - Dorr, David

AU - McKoy, June M.

AU - Edwards, Beatrice J.

AU - Hurdle, John F.

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AU - Lau, Denys T.

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AU - Weitzman, Sigmund A.

AU - Belknap, Steven M.

AU - Djulbegovic, Benjamin

AU - Tallman, Martin S.

AU - Kuzel, Timothy M.

AU - Benson, Al B.

AU - Evens, Andrew

AU - Trifilio, Steven M.

AU - Courtney, D. Mark

AU - Raisch, Dennis W.

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