The role of tigecycline in the treatment of infections in light of the new black box warning

Expert Review of Anti-Infective Therapy

Volumn 12, Issue 4, 2014, Pages 397-400

  Dixit, Deepali ^a   Madduri, Rani Patel ^b   SharM A , Roopali ^c,d  

^a RUTGERS UNIVERSITY   (United States)

^b Hunterdon Medical Center   (United States)

^c Arnold and Marie Schwartz College of Pharmacy   (United States)

^d SUNY DOWNSTATE MEDICAL CENTER   (United States)

Author keywords

black box warning; meta analysis; mortality; severe infection; tigecycline

Indexed keywords

TIGECYCLINE; ANTIINFECTIVE AGENT; MINOCYCLINE;

ABDOMINAL INFECTION; ACINETOBACTER BAUMANNII; ANTIBIOTIC RESISTANCE; ANTIBIOTIC THERAPY; BACTERIAL PNEUMONIA; BACTERIAL SUPERINFECTION; COMMUNITY ACQUIRED PNEUMONIA; DRUG APPROVAL; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG USE; HUMAN; INFECTION; KLEBSIELLA PNEUMONIAE; MONOTHERAPY; MORTALITY; REVIEW; SKIN INFECTION; TREATMENT INDICATION; VENTILATOR ASSOCIATED PNEUMONIA; ANALOGS AND DERIVATIVES; COMMUNICABLE DISEASES; DRUG COMBINATION; DRUG EFFECTS; FOOD AND DRUG ADMINISTRATION; MALE; MULTIDRUG RESISTANCE; PNEUMONIA, VENTILATOR-ASSOCIATED; RISK ASSESSMENT; UNITED STATES;

ANTI-BACTERIAL AGENTS; COMMUNICABLE DISEASES; DRUG RESISTANCE, MULTIPLE, BACTERIAL; DRUG THERAPY, COMBINATION; HUMANS; MALE; MINOCYCLINE; PNEUMONIA, VENTILATOR-ASSOCIATED; RISK ASSESSMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84896361306     PISSN: 14787210     EISSN: 17448336     Source Type: Journal    
DOI: 10.1586/14787210.2014.894882     Document Type: Review

References (29)

1. Kasbekar N. Tigecycline: a new glycycline antimicrobial agent. Am J Health Syst Pharm 2006;63(13):1235-43
2. Tygacil (Tigecycline), package insert. Pfizer, Inc., Philadelphia, PA, USA; 2005
3. Livermore DM. Tigecycline: what is it, and where should it be used? J Antimicrob Chemother 2005;56(4):611-14
4. US FDA. FDA drug safety communication: increased risk of death with Tygacil (Tigecycline) compared to other antibiotics used to treat similar infections. 2010 [Last accessed December 2013
5. US FDA. FDA drug safety communication: FDA warns of increased risk of death with IV antibacterial Tygacil (Tigecycline) and approves new Boxed Warning. 2013 [Last accessed December 2013
6. Ellis-Grosse EJ, Babinchak T, Dartois N, et al. The efficacy and safety of tigecycline in the treatment of skin and skin-structure infections: results of two double-blind phase 3 comparison studies with vancomycin-aztreonam. Clin Infect Dis 2005;41(Suppl 5):S341-53
7. Fomin P, Beuran M, Gradauskas A, et al. Tigecycline is efficacious in the treatment of complicated intra-abdominal infections. Int J Surg 2005;3(1):35-47
8. Bergallo C, Jasovich A, Teglia O, et al. Safety and efficacy intravenous tigecycline in treatment of community-acquired pneumonia: results from a double-blind randomized phase 3 comparison study with levofloxacin. Diagn Microbiol Infect Dis 2009;63(1):52-61
9. Freire AT, Melnyk V, Kim MJ, et al. Comparison of tigecycline with imipenem/ cilastatin for the treatment of hospital-acquired pneumonia. Diagn Microbiol Infect Dis 2010;68(2):140-51
10. Ramirez J, Dartois N, Gandjini H, et al. Randomized phase 2 trial to evaluate the clinical efficacy of two high-dosage tigecycline regimens versus imipenem-cilastatin for treatment of hospital-acquired pneumonia. Antimicrob Agents Chemother 2013;57(4):1756-62
11. Cai Y, Wang R, Liang B, et al. Systematic review and meta-analysis of the effectiveness and safety of tigecycline for treatment of infectious disease. Antimicrob Agents Chemother 2011;55(3):1162-72
12. Yahav D, Lador A, Paul M, Leibovici L. Efficacy and safety of tigecycline: a systematic review and meta-analysis. J Antimicrob Chemother 2011;66:1963-71
13. Tasina E, Haidich AB, Kokkali S, et al. Efficacy and safety of tigecycline for the treatment of infectious diseases: a metaanalysis. Lancet Infect Dis 2011;11:834-44
14. Ioannidis JP. Interpretation of tests of heterogeneity and bias in meta-analysis. J Eval Clin Pract 2008;14(5):951-7
15. Prasad P, Sun J, Danner RL, et al. Excess deaths associated with tigecycline after approval based on non-inferiority trials. Clin Infect Dis 2012;54:1699-709
16. Powers J. Asking the right questions: morbidity, mortality, and measuring what's important in unbiased evaluations of antimicrobials. Clin Infect Dis 2012;54(12): 1710-13
17. Curcio D, Verde PE. Comment on: efficacy and safety of tigecycline: a systematic review and meta-analysis. J Antimicrob Chemother 2011;66(12):2893-5
18. Verde PE, Curcio D. Imbalanced mortality evidence for tigecycline: 2011, the year of the meta-analysis. Clin Infect Dis 2012; 55(3):471-2
19. Poulakou G, Kontopidou F, Paramythiotou E, et al. Tigecycline in the treatment of infections from multi-drug resistant gram-negative pathogens. J Infect 2009;58:273-84
20. Rodŕguez-Avial C, Rodŕguez-Avial I, Merino P, Picazo JJ. Klebsiellapneumoniae: development of a mixed population of carbapenem and tigecycline resistance during antimicrobial therapy in a kidney transplant patient. Clin Microbiol Infect 2012;18:61-6
21. Hornsey M, Loman N, Wareham DW, et al. Whole-genome comparison of two Acinetobacter baumannii isolates from a single patient, where resistance developed during tigecycline therapy. J Antimicrob Chemother 2011;66:1499-503
22. Chen LY, Chen TC, Chen YH, et al. Microbial isolation and emer- gence of antimicrobial resistance associated with tigecycline usage. J Microbiol Immunol Infect 2011;44:352-7
23. Gallagher JC, Rouse HM. Tigecycline for the treatment of Acinetobacter infections: a case series. Ann Pharmacother 2008;42:1188-94
24. Sun Y, Cai Y, Liu X, et al. The emergence of clinical resistance to tigecycline. Int J Antimicrob Agents 2013;41:110-16
25. Entenza JM, Moreillon P. Tigecycline in combination with other antimicrobials: a review of in vitro, animal and case report studies. Int J Antimicrob Agents 2009; 34(1):8.e1-8.e9
26. Hirsch EB, Tam VH. Detection and treatment options for Klebsiella pneumonia carbapenemases (KPCs): an emerging cause of multidrug-resistant infection. Antimicrob Chemother 2010;12:12
27. Qureshi ZA, Paterson DL, Potoski BA, et al. Treatment outcome of bacteremia due to KPC-producing Klebsiella pneumoniae: superiority of combination antimicrobial regimens. Antimicrob Agents Chemother 2012;56(4):2108-13
28. Zarkotou O, Pournaras S, Tselioti P, et al. Predictors of mortality in patients with bloodstream infections caused by KPCproducing Klebsiella pneumoniae and impact of appropriate antimicrobial treatment. Clin Microbiol Infect 2011;17:1798-803
29. Tumbarello M, Viale P, Viscoli C, et al. Predictors of mortality in bloodstream infections caused by KPC-producing Klebsiella pneumoniae: importance of combination therapy. Clin Infect Dis 2012; 55(7):943-50