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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.
Arch Intern Med. 2007 May 28; 167(10):1041-9.AI

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<.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.

Authors+Show Affiliations

Northwestern University Feinberg School of Medicine, Chicago, IL 60611, USA. cbenne@northwestern.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

17533207

Citation

Bennett, Charles L., et al. "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, 2007, pp. 1041-9.
Bennett CL, Nebeker JR, Yarnold PR, et al. Evaluation of serious adverse drug reactions: a proactive pharmacovigilance program (RADAR) vs safety activities conducted by the Food and Drug Administration and pharmaceutical manufacturers. Arch Intern Med. 2007;167(10):1041-9.
Bennett, C. L., Nebeker, J. R., Yarnold, P. R., Tigue, C. C., Dorr, D. A., McKoy, J. M., Edwards, B. J., Hurdle, J. F., West, D. P., Lau, D. T., Angelotta, C., Weitzman, S. A., Belknap, S. M., Djulbegovic, B., Tallman, M. S., Kuzel, T. M., Benson, A. B., Evens, A., Trifilio, S. M., ... Raisch, D. W. (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, 167(10), 1041-9.
Bennett CL, et al. Evaluation of Serious Adverse Drug Reactions: a Proactive Pharmacovigilance Program (RADAR) Vs Safety Activities Conducted By the Food and Drug Administration and Pharmaceutical Manufacturers. Arch Intern Med. 2007 May 28;167(10):1041-9. PubMed PMID: 17533207.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of serious adverse drug reactions: a proactive pharmacovigilance program (RADAR) vs safety activities conducted by the Food and Drug Administration and pharmaceutical manufacturers. AU - Bennett,Charles L, AU - Nebeker,Jonathan R, AU - Yarnold,Paul R, AU - Tigue,Cara C, AU - Dorr,David A, AU - McKoy,June M, AU - Edwards,Beatrice J, AU - Hurdle,John F, AU - West,Dennis P, AU - Lau,Denys T, AU - Angelotta,Cara, 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, PY - 2007/5/30/pubmed PY - 2007/6/30/medline PY - 2007/5/30/entrez SP - 1041 EP - 9 JF - Archives of internal medicine JO - Arch. Intern. Med. VL - 167 IS - 10 N2 - 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. SN - 0003-9926 UR - https://www.unboundmedicine.com/medline/citation/17533207/Evaluation_of_serious_adverse_drug_reactions:_a_proactive_pharmacovigilance_program__RADAR__vs_safety_activities_conducted_by_the_Food_and_Drug_Administration_and_pharmaceutical_manufacturers_ L2 - https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/10.1001/archinte.167.10.1041 DB - PRIME DP - Unbound Medicine ER -