Validity of diagnostic codes to identify cases of severe acute liver injury in the U.S. Food and Drug Administration's Mini-Sentinel Distributed Database-Reference-Cited by-同舟云学术

Validity of diagnostic codes to identify cases of severe acute liver injury in the U.S. Food and Drug Administration's Mini-Sentinel Distributed Database

Published:2013-06-25 Issue:8 Volume:22 Page:861-872
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Lo Re Vincent¹²,Haynes Kevin²,Goldberg David²³,Forde Kimberly A.²³,Carbonari Dena M.²,Leidl Kimberly B. F.²,Hennessy Sean²,Reddy K. Rajender³,Pawloski Pamala A.⁴,Daniel Gregory W.⁵⁶,Cheetham T. Craig⁷,Iyer Aarthi⁸,Coughlin Kara O.⁸,Toh Sengwee⁸,Boudreau Denise M.⁹,Selvam Nandini⁵,Cooper William O.¹⁰,Selvan Mano S.¹¹,VanWormer Jeffrey J.¹²,Avigan Mark I.¹³,Houstoun Monika¹³,Zornberg Gwen L.¹³,Racoosin Judith A.¹³,Shoaibi Azadeh¹³

Affiliation:

1. Division of Infectious Diseases, Department of Medicine, Perelman School of Medicine; University of Pennsylvania; Philadelphia PA USA

2. Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics and Epidemiology, Perelman School of Medicine; University of Pennsylvania; Philadelphia PA USA

3. Division of Gastroenterology, Department of Medicine, Perelman School of Medicine; University of Pennsylvania; Philadelphia PA USA

4. HealthPartners Institute for Education and Research; Bloomington MN USA

5. HealthCore, Inc.; Wilmington DE USA

6. Engelberg Center for Health Care Reform; The Brookings Institution; Washington DC USA

7. Pharmacy Analytical Service; Kaiser Permanente Southern California; Downey CA USA

8. Department of Population Medicine; Harvard Medical School and Harvard Pilgrim Health Care Institute; Boston MA USA

9. Group Health Research Institute; Seattle WA USA

10. Vanderbilt University School of Medicine; Nashville TN USA

11. Competitive Health Analytics; Humana Inc.; Louisville KY USA

12. Marshfield Clinic Research Foundation; Marshfield WI USA

13. U.S. Food and Drug Administration; Silver Spring MD USA

Funder

U.S. Food and Drug Administration

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/pds.3470/fullpdf

Reference27 articles.

1. PhRMA/FDA/AASLD drug-induced hepatotoxicity white paper postmarketing considerations http://www.fda.gov/cder/livertox/postmarket.pdf

2. Drug-induced liver disorders: implications for drug development and regulation;Kaplowitz;Drug Saf,2001

3. Drug-induced hepatotoxicity;Lee;N Engl J Med,2003

4. Drug-related hepatotoxicity;Navarro;N Engl J Med,2006

5. Safety of newly approved drugs: implications for prescribing;Temple;JAMA,2002

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