Evaluation of serious adverse drug reactions: a proactive pharmacovigilance program (RADAR) vs safety activities conducted by the Food and Drug Administration and pharmaceutical manufacturers.

Evaluation of serious adverse drug reactions: a proactive pharmacovigilance program (RADAR) vs safety activities conducted by the Food and Drug Administration and pharmaceutical manufacturers. Research Abstract Details 

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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. Abstract Text:

Charles L Bennett,Jonathan R Nebeker,Paul R Yarnold,Cara C Tigue,David A 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,Dennis W Raisch,

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<.001) and a 9-fold higher rate of including basic science findings (34% vs 4%; P = .08). Safety notifications were disseminated earlier by pharmaceutical suppliers (2 vs 4 years after approval, respectively), although notifications were less likely to include information on incidence (46% vs 93%; P = .02), outcomes (8% vs 100%; P<.001), treatment or prophylaxis (25% vs 93%; P<.001), or references (8% vs 80%; P<.001). CONCLUSION: Proactive safety efforts conducted by the RADAR investigators are more comprehensive than those conducted by the FDA and pharmaceutical manufacturers, but dissemination of related safety notifications is less timely.

Evaluation of serious adverse drug reactions: a proactive pharmacovigilance program (RADAR) vs safety activities conducted by the Food and Drug Administration and pharmaceutical manufacturers. Publishing Authors By Initials

CL Bennett,JR Nebeker,PR Yarnold,CC Tigue,DA Dorr,JM McKoy,BJ Edwards,JF Hurdle,DP West,DT Lau,C Angelotta,SA Weitzman,SM Belknap,B Djulbegovic,MS Tallman,TM Kuzel,AB Benson,A Evens,SM Trifilio,DM Courtney,DW Raisch,

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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. Journal Published:

PUBLICATION TYPE: Research Support, U.S. Gov't,

Journal: Archives of internal medicine

VOLUME: 167

Page Numbers: 1041-9

Journal Abbreviation: Arch. Intern. Med.

ISSN: 0003-9926

DAY: 28

MONTH: May

YEAR: 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. Information

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LANGUAGE: eng

NlmUniqueID: 372440

Evaluation of serious adverse drug reactions: a proactive pharmacovigilance program (RADAR) vs safety activities conducted by the Food and Drug Administration and pharmaceutical manufacturers. Keywords Mesh Terms:

KEYWORDS: United States Food and Drug Administrati

MESH TERMS: methods

Chemical & Substance for Abstract: Evaluation of serious adverse drug reactions: a proactive pharmacovigilance program (RADAR) vs safety activities conducted by the Food and Drug Administration and pharmaceutical manufacturers. Information

Substance Name: Pharmaceutical Preparations

Registry Number: 0

Grant and Affiliation Information for Evaluation of serious adverse drug reactions: a proactive pharmacovigilance program (RADAR) vs safety activities conducted by the Food and Drug Administration and pharmaceutical manufacturers.

AFFILIATION: Northwestern University Feinberg School of Medicine, Chicago, IL 60611, USA. cbenne@northwestern.edu

Country: United States

AGENCY: United States NCI

GRANT: P30 CA60553

ACRONYM: CA

MEDLINETA: Arch Intern Med

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