A new respiratory fluoroquinolone, oral gemifloxacin: A safety profile in context

International Journal of Antimicrobial Agents

Volumn 23, Issue 5, 2004, Pages 421-429

  Ball, P ^a,f   Mandell, L ^b   Patou, G ^c   Dankner, W ^d   Tillotson, G ^e  

^a UNIVERSITY OF ST ANDREWS   (United Kingdom)

^b MCMASTER UNIVERSITY   (Canada)

^c Genesoft Pharmaceuticals Inc   (United States)

^d PAREXEL INTERNATIONAL   (United States)

^e PUBLIC HEALTH RESEARCH INSTITUTE   (United States)

^f NONE

Author keywords

Adverse effects; Gemifloxacin; Maculo papular rash

Indexed keywords

ALANINE AMINOTRANSFERASE; ALUMINUM MAGNESIUM HYDROXIDE; AMOXICILLIN PLUS CLAVULANIC ACID; BETA LACTAM ANTIBIOTIC; CEFTRIAXONE; CEFUROXIME AXETIL; CIMETIDINE; CIPROFLOXACIN; CLARITHROMYCIN; DIGOXIN; GEMIFLOXACIN; LEVOFLOXACIN; LIVER ENZYME; MACROLIDE; OFLOXACIN; OMEPRAZOLE; ORAL CONTRACEPTIVE AGENT; QUINOLINE DERIVED ANTIINFECTIVE AGENT; TEMAFLOXACIN; THEOPHYLLINE; TROVAFLOXACIN; WARFARIN;

ABDOMINAL PAIN; AGING; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTHRALGIA; BACKACHE; BRONCHITIS; CANDIDIASIS; CHRONIC ASPECIFIC RESPIRATORY TRACT DISEASE; CLINICAL TRIAL; CONSTIPATION; DIARRHEA; DIZZINESS; DRUG BIOAVAILABILITY; DRUG ERUPTION; DRUG INDUCED DISEASE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; DYSPNEA; ENZYME BLOOD LEVEL; ERYTHEMA; FATIGUE; FLATULENCE; GASTROINTESTINAL SYMPTOM; HEADACHE; HEART ARRHYTHMIA; HUMAN; HYPERGLYCEMIA; HYPOGLYCEMIA; HYPOKALEMIA; INJURY; INSOMNIA; KIDNEY DISEASE; LIVER DISEASE; LUNG CARCINOMA; MYALGIA; NAUSEA; PAPULE; PHARYNGITIS; PHOTOTOXICITY; PNEUMONIA; PRIORITY JOURNAL; PUSTULE; QT PROLONGATION; RASH; RESPIRATORY FAILURE; RESPIRATORY TRACT DISEASE; REVIEW; RHINITIS; SINUSITIS; SUNBURN; TASTE DISORDER; THROMBOCYTOSIS; UPPER RESPIRATORY TRACT INFECTION; URTICARIA; VIRUS INFECTION; VOMITING;

ADMINISTRATION, ORAL; ANTI-INFECTIVE AGENTS; BACTERIAL INFECTIONS; CLINICAL TRIALS; DRUG THERAPY, COMBINATION; FLUOROQUINOLONES; HUMANS; NAPHTHYRIDINES;

EID: 2342468027     PISSN: 09248579     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijantimicag.2004.02.014     Document Type: Review

References (27)

1. Cormican M.G., Jones R.N. Antimicrobial activity and spectrum of LB20304, a novel fluoronaphthyridone. Antimicrob Agents Chemother. 41:1997;204-211
2. Johnson D.M., Jones R.N., Erwin M.E. the Quality Control Study Group Anti-streptococcal activity of SB-265805 (LB20304), a novel fluoronaphthyridone, compared with five other compounds, including quality control guidelines. Diagn Microbiol Infect Dis. 33:1999;87-91
3. Ball P., Mandell L., Niki Y., Tillotson G. Comparative tolerability of the newer fluoroquinolone antibacterials. Drug Saf. 21:1999;407-421
4. Blum M.D., Graham D.J., McCloskey C.A. Temafloxacin syndrome: review of 95 cases. Clin Infect Dis. 18:1994;946-950
5. EMEA (European Agency for the Evaluation of Medicinal Products). Public statement on Trovan/Trovan IV/Turvel/Turvel IV (trovafloxacin/alatrofloxacin). Recommendation to suspend the marketing authorisation in the European Union. EMEA/18046/99; 15 June 1999.
6. FDA (Food and Drug Administration, US Department of Health and Human Services). FDA Talk Paper: FDA issues public health advisory on liver toxicity associated with the antibiotic Trovan; 9 June 1999.
7. Ball P. New antibiotics for community acquired lower respiratory tract infections: improved activity at a cost? Int J Antimicrob Agents. 16:2000;263-272
8. Ball P., Tillotson G.S. Tolerability of fluoroquinolone antibiotics: past, present and future. Drug Saf. 13:1995;343-358
9. Domagala J.M. Structure-activity and structure-side-effect relationships for the fluoroquinolone antibacterials. J Antimicrob Chemother. 33:1994;685-706
10. Lipsky B.A., Baker C.A. Fluoroquinolone toxicity profiles: a review focusing on newer agents. Clin Infect Dis. 28:1999;352-364
11. Ball P. Quinolone induced QT interval prolongation: a not so unexpected class effect. J Antimicrob Chemother. 45:2000;557-559
12. Frothingham R. Rates of torsades de pointes associated with ciprofloxacin, ofloxacin, levofloxacin, gatifloxacin and moxifloxacin. Pharmacotherpy. 21:2001;1468-1472
13. Frothingham R. Authors reply [to correspondence]. Pharmacotherapy. 22:2002;668-672
14. Rubinstein E., Camm J. Cardiotoxicity of fluoroquinolones. J Antimicrob Chemother. 49:2002;593-596
15. Vousden M., Ferguson J., Richards J., Bird N., Allen A. Evaluation of phototoxic potential of gemifloxacin in healthy volunteers compared with ciprofloxacin. Chemotherapy. 45:1999;512-520
16. Allen A., Vousden M., Lewis A. Effect of omeprazole on the pharmacokinetics of oral gemifloxacin in healthy volunteers. Chemotherapy. 45:1999;496-503
17. ® on the bioavailability of oral gemifloxacin in healthy volunteers. Chemotherapy. 45:1999;504-511
18. Davy M., Bird N., Rost K.L., Fuder H. Lack of effect of gemifloxacin on the steady-state pharmacodynamics of warfarin in healthy volunteers. Chemotherapy. 45:1999;491-495
19. Allen A., Bird N., Bygate E., Lewis A., Pay V., Romain D. Lack of pharmacokinetic interaction between repeat-dose gemifloxacin and the oral contraceptive Microgynon 21. Span J Chemother. 13(Suppl 2):2000;5. [Abstract M115]
20. Davy M., Allen A., Bird N., Rost K.L., Fuder H. Lack of effect of gemifloxacin on the steady-state pharmacokinetics of theophylline in healthy volunteers. Chemotherapy. 45:1999;478-484
21. Vousden M., Allen A., Lewis A., Ehren N. Lack of pharmacokinetic interaction between gemifloxacin and digoxin in healthy elderly volunteers. Chemotherapy. 45:1999;485-490
22. Saliba F., Isaac L., Barker P.J., et al. The pharmacokinetics and tolerability of a single oral dose of gemifloxacin in patients with mild or moderate hepatic impairment. Span J Chemother. 13(Suppl 2):2000;4. [Abstract M112]
23. Allen A., Walls C., Bird N., et al. Pharmacokinetics of gemifloxacin administered to patients with severe renal impairment and patients on dialysis. Span J Chemother. 13(Suppl 2):2000a;5. [Abstract M131]
24. Ball P. Quinolone generations: natural history or natural selection. J Antimicrob Chemother. 46:2000;17-24
25. Chen H.J.L., Bloch K.J., MacLean J.A. Acute eosinophilic hepatitis from trovafloxacin. N Engl J Med. 342:2000;359-360
26. Pay V, Allen A, Bygate E, Paanakker L, Montague T. Multiple dose pharmacokinetics and tolerability of gemifloxacin following once daily repeat oral 320 mg doses in healthy elderly volunteers. In: Abstracts of the 40th Interscience Conference on Antimicrobial Agents and Chemotherapy, Toronto. American Society for Microbiology: 17-20 September 2000 [Abstract 2265].
27. Henkel TJ, McKay D, Young C. Safety of gemifloxacin in patients aged >65 years with respiratory and urinary tract infections. In: Abstracts of the 40th Interscience Conference on Antimicrobial Agents and Chemotherapy, Toronto. American Society for Microbiology: 17-20 September 2000 [Abstract M813].