Risk of hepatotoxicity associated with the use of telithromycin: A signal detection using data mining algorithms

Annals of Pharmacotherapy

Volumn 42, Issue 12, 2008, Pages 1791-1796

  Chen, Yan ^a,b   Guo, Jeff J ^a   Healy, Daniel P ^a   Lin, Xiaodong ^b   Patel, Nick C ^c,d  

^a UNIVERSITY OF CINCINNATI ACADEMIC HEALTH CENTER   (United States)

^b UNIVERSITY OF CINCINNATI   (United States)

^c UNIVERSITY OF GEORGIA   (United States)

^d MEDICAL COLLEGE OF GEORGIA   (United States)

Author keywords

Data mining algorithms; Spontaneous reporting system; Telithromycin

Indexed keywords

TELITHROMYCIN;

ADOLESCENT; ADULT; AGED; ARTICLE; DATA MINING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG USE; FEMALE; HUMAN; LIVER TOXICITY; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; SIGNAL DETECTION;

ADVERSE DRUG REACTION REPORTING SYSTEMS; ALGORITHMS; ANTI-BACTERIAL AGENTS; DATA INTERPRETATION, STATISTICAL; HUMANS; KETOLIDES; LIVER DISEASES; ODDS RATIO; POISSON DISTRIBUTION; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 57449117697     PISSN: 10600280     EISSN: None     Source Type: Journal    
DOI: 10.1345/aph.1L315     Document Type: Article

References (25)

1. Food and Drug Administration. NDA 21-144 approval letter. www.fda.gov/cder/foi/appletter/2004/211441tr.pdf (accessed 2008 Apr 29).
2. Ross DB. The FDA and the case of Ketek. N Engl J Med 2007;356:1601-4.
3. Clay KD, Hanson JS, Pope SD, Rissmiller RW, Purdum PP, Banks PM. Severe hepatotoxicity of telithromycin: three case reports and literature review. Ann Intern Med 2006;144:415-20.
4. Food and Drug Administration. FDA public health advisory: Ketek (telithromycin) tablets. www.fda.gov/cder/drug/advisory/telithromycin.htm (accessed 2008 Jun 18).
5. Ketek labeling revision. www.fda.gov/cder/foi/label/2007/021144s0121bl. pdf (accessed 2008 Jun 2).
6. Carbon C, Moola S, Velancsics I, et al. Telithromycin 800 mg once daily for seven to ten days is an effective and well-tolerated treatment for community acquired pneumonia. Clin Microbiol Infect 2003;9:691-703.
7. Roos K, Brunswig-Pitschner C, Kostrica R, et al. Efficacy and tolerability of once daily therapy with telithromycin for 5 or 10 days for the treatment of acute maxillary sinusitis. Chemotherapy 2002;48:100-8.
8. Bolesta S, Roslund BP. Elevated hepatic transaminases associated with telithromycin therapy: a case report and literature review. Am J Health Syst Pharm 2008;65:37-41.
9. Dore DD, DiBello JR, Lapane KL. Telithromycin use and spontaneous reports of hepatotoxicity. Drug Saf 2007;30:697-703.
10. Szarfman A, Machado SG, O'Neill RT. Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDA's spontaneous reports database. Drug Saf 2002;25:381-92.
11. van Puijenbroek EP, Bate A, Leufkens HGM, Lindquist M, Orre R, Egberts ACG. A comparison of measures of disproportionality for signal detection in spontaneous reporting system for adverse drug reactions. Pharmacoepidemiol Drug Saf 2002;11:3-10.
12. Evans SJV, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf 2001;10:483-6.
13. DuMouchel W. Bayesian data mining in large frequency tables, with an application to FDA spontaneous reporting system. Am Statistician 1999;53:177-90.
14. Bate A, Lindquist M, Edwards IR, Orre R. A data mining approach for signal detection and analysis. Drug Saf 2002;25:393-7.
15. Almenoff J, Tonning JM, Gould AL, et al. Perspectives on the use of data mining in pharmacovigilance. Drug Saf 2005;28:981-1007.
16. Wilson AM, Thabane L, Holbrook A. Application of data mining techniques in pharmacovigilance. Br J Clin Pharmacol 2003;57:127-34.
17. Trontell AE. How the US Food and Drug Administration defines and detects adverse drug events. Curr Ther Res Clin Exp 2001;62:641-9.
18. Medical Dictionary for Regular Activities (MedDRA). www.fda.gov/medwatch/ REPORT/meddra.htm (accessed 2006 Nov 2).
19. Pringle E [TMS Health]. Scoop Independent News. Lawmakers demand answers about Ketek from FDA, 2006 [online]. www.scoop.co.nz/stories/HL0606/S00279.htm (accessed 2008 Apr 29).
20. DuMouchel W, Smith ET, Beasley R, et al. Association of asthma therapy and Churg-Strauss syndrome: an analysis of postmarketing surveillance data. Clin Ther 2004;26:1092-104.
21. Sanz E, De-las-Cuevas C, Kiuru A, Bate A, Edwards R. Selective serotonin reuptake inhibitors in pregnant women and neonatal withdrawal syndrome: a database analysis. Lancet 2005;365:482-7.
22. Almenoff JS, LaCroix KL, Yuen NA, Fram D, DuMouchel W. Comparative performance of two quantitative safety signaling methods: implications for use in a pharmacovigilance department. Drug Saf 2006;29:875-87.
23. Hauben M, Reich L. Safety related drug-labeling changes: findings from two data mining algorithms. Drug Saf 2004;27:735-44.
24. Hauben M, Zhou XF. Quantitative methods in pharmacovigilance: focus on signal detection. Drug Saf 2003;26:159-86.
25. Pariente A, Gregoire F, Fourrier-Reglat A, Haramburu F, Moore N. Impact of safety alerts on measures of disproportionality in spontaneous reporting databases: the notoriety bias. Drug Saf 2007;30:1-8.