Clinical safety profile of newer fluoroquinolones

Infections in Medicine

Volumn 16, Issue SUPPL. F, 1999, Pages 41-53

  Rodvold, Keith A ^a,b,c  

^a UNIVERSITY OF ILLINOIS AT CHICAGO   (United States)

^b Department of Pharmacy Practice   (United States)

^c UNIVERSITY OF ILLINOIS   (United States)

Author keywords

Adverse drug events; Fluoroquinolones

Indexed keywords

EID: 0002624003     PISSN: 07496524     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (93)

1. Paton JH, Reeves DS. Clinical features and management of adverse effects of quinolone antibacterials. Drug Saf. 1991;6:8-27.
2. Norrby SR. Side-effects of quinolones: comparisons between quinolones and other antibiotics. Eur J Clin Microbiol Infect Dis. 1991;10:378-383.
3. Hooper DC, Wolfson JS. Adverse effects. In: Hooper DC, Wolfson JS, eds. Quinolone Antimicrobial Agents. 2nd ed. Washington, DC: American Society of Microbiology; 1993: 489-512.
4. Lietman PS. Fluoroquinolone toxicities: an update. Drugs. 1995:42(suppl 2):159-163.
5. Stahlman R, Lode H. Safety overview: toxicity, adverse effects, and drug interactions. In: Andriole VT, ed. The Quinolones. 2nd ed. San Diego: Academic Press; 1998:370-416.
6. Segev S, Yaniv I, Haverstock D, et al. Safety of long-term therapy with ciprofloxacin: data analysis of controlled clinical trials and review. Clin Infect Dis. 1999;28:299-308.
7. Lipsky BA, Baker CA. Fluoroquinolone toxicity profiles: a review focusing on newer agents. Clin Infect Dis. 1999;28:352-364.
8. Lumpkin, MM. Public Health Advisory, Food and Drug Administration: Trovan (trovafloxacin/alatrofloxacin) [Letter]. June 10, 1999.
9. Blum MD, Graham DJ, McCloskey CA. Temafloxacin syndrome: review of 95 cases. Clin Infect Dis. 1994;18:946-950.
10. Finch RG. The withdrawal of temafloxacin: are there implications for other quinolones? Drug Saf. 1993;8:9-11.
11. Radandt JM, Marchbanks CR, Dudley MN. Interactions of fluoroquinolones with other drugs: mechanisms, variability, clinical significance, and management. Clin Infect Dis. 1992;14:272-284.
12. Rodvold KA, Piscitelli SC. New oral macrolide and fluoroquinolones antibiotics: an overview of pharmacokinetics, interactions, and safety. Clin Infect Dis. 1993;17 (suppl 1): S192-S199.
13. Nix DE. Drug-drug interactions with fluoroquinolones antimicrobial agents. In: Hooper DC, Wolfson JS, eds. Quinolone Antimicrobial Agents. 2nd ed. Washington, DC: American Society of Microbiology; 1993:225-258.
14. Borcherding SM, Stevens R, Nicholas RA, et al. Quinolones: a practical review of clinical uses, dosing considerations, and drug interactions. J Fam Pract. 1996;42:69-78.
15. Guay DRP. Implications of quinolone pharmacokinetic drug interactions. Hosp Pharm. 1997;32:677-690.
16. Domagala JM. Structure-activity and structure-side-effect relationships for the quinolone antibacterials. J Antimicrob Chemother. 1994;33:685-706.
17. Langan CE, Cranfield R, Breisch S, et al. Randomized, double-blind study of grepafloxacin versus amoxycillin in patients with acute bacterial exacerbations of chronic bronchitis. J Antimicrob Chemother. 1997;40:63-72.
18. O'Doherty B, Dutchman DA, Pettit R, et al. Randomized, double-blind, comparative study of grepafloxacin and amoxycillin in the treatment of patients with community-acquired pneumonia. J Antimicrob Chemother. 1997;40(suppl A):73-81.
19. DeAbate CA, Russell M, McElvaine P, et al. Safety and efficacy of oral levofloxacin versus cefuroxime axetil in acute bacterial exacerbations of chronic bronchitis. Respir Care. 1997;42:206-213.
20. Habib MP, Gentry LO, Rodriguez-Gomez G, et al. Multicenter, randomized study comparing efficacy and safety of oral levofloxacin and cefaclor in treatment of acute bacterial exacerbations of chronic bronchitis. Infect Dis Clin Pract. 1998;7:101-109.
21. Shah PM, Maesen FPV, Dolmann A, et al. Levofloxacin versus cefuroxime axetil in treatment of acute exacerbations of chronic bronchitis: results of a randomized double-blind study. J Antimicrcb Chemother. 1999; 43:529-539.
22. Davies BI, Maesen FPV. Clinical effectiveness of levofloxacin in patients with acute purulent exacerbations of chronic bronchitis: the relationship with in-vitro activity. J Antimicrob Chemother. 1999;43(suppl C):83-90.
23. File TM, Segreti J, Dunbar L, et al. A multicenter, randomized study comparing the efficacy and safety of intravenous and/ or oral levofloxacin versus ceftriaxone and/ or cefuroxime axetil in treatment of adults with community-acquired pneumonia. Antimicrob Agents Chemother. 1997;41:1965-1972.
24. Allegra L, Konietzko N, Leophonte P, et al. Comparative safety and efficacy of sparfloxacin in the treatment of acute exacerbations of chronic obstructive pulmonary disease: a double-blind, randomised, parallel, multicentre study. J Antimicrob Chemother. 1996;37(suppl A):93-104.
25. DeAbate CA, Henry D, Bensch G, et al. Sparfloxacin vs ofloxacin in the treatment of acute bacterial exacerbations of chronic bronchitis: a multicenter, double-blind, randomized, comparative study. Chest. 1998;114:120-130.
26. Lode H, Garau J, Grassi C, et al. Treatment of community-acquired pneumonia: a randomized comparison of sparfloxacin, amoxycillin-clavulanic acid and erythromycin. Eur Respir J. 1995:8:1999-2007.
27. Portier H, May T, Proust A, et al. Comparative efficacy of sparfloxacin in comparison with amoxycillin plus ofloxacin in the treatment of community-acquired pneumonia. J Antimicrob Chemother. 1996(suppl A):83-91.
28. Ortqvist A, Valtonen M, Cars O, et al. Oral empiric treatment of community-acquired pneumonia: a multicenter, double-blind, randomized study comparing sparfloxacin with roxithromycin. Chest. 1996;110:1499-1506.
29. Donowitz GR, Brandon ML, Salisbury JP, et al. Sparfloxacin versus cefaclor in the treatment of patients with community-acquired pneumonia: a randomized, double-masked, comparative, multicenter study. Clin Ther. 1997;19:936-953.
30. Aubier M, Verster R, Regamey C, et al. Once-daily sparfloxacin versus high-dosage amoxicillin in the treatment of community-acquired, suspected pneumococcal pneumonia in adults. Clin Infect Dis. 1998;26:1312-1320.
31. Ramirez J, Unowsky J, Talbot GH, et al. Sparfloxacin versus clarithromycin in the treatment of community-acquired pneumonia. Clin Ther. 1999;21:103-117.
32. O'Doherty B, Daniel R, et al. Treatment of acute exacerbations of chronic bronchitis: comparison of trovafloxacin and amoxicillin in a multicentre, double-blind, double-dummy study. Eur J Clin Microbiol Infect Dis. 1998;17:441-446.
33. Leophonte P, Baldwin RJ, Pluck N. Trovafloxacin versus amoxicillin/clavulanic acid in the treatment of acute exacerbations of chronic obstructive bronchitis. Eur J Clin Microbiol Infect Dis. 1998;17:434-440.
34. Tremolieres F, deKock F, Pluck N, et al. Trovafloxacin versus high-dose amoxicillin (1 g three times daily) in the treatment of community-acquired bacterial pneumonia. Eur J Clin Microbiol Infect Dis. 1998;17:447-453.
35. Grepafloxacin (Raxar) [package insert]. Research Triangle Park, NC: Glaxo Wellcome, 1997.
36. Levofloxacin (Levaquin) [package insert]. Raritan, NJ: Ortho-McNeil Pharmaceutical, 1996.
37. Sparfloxacin (Zagam) [package insert]. Collegeville, Pa: Rhone-Poulenc Rorer Pharmaceuticals, 1996.
38. Trovafloxacin (Trovan) [package insert]. New York: Pfizer, 1999.
39. Chodosh S, Lakshminarayan S, Swarz H, et al. Efficacy and safety of a 10-day course of 400 or 600 milligrams of grepafloxacin once daily for treatment of acute bacterial exacerbations of chronic bronchitis: comparison with a 10-day course of 500 milligrams of ciprofloxacin twice daily. Antimicrob Agents Chemother. 1998;42:114-120.
40. DeAbate CA, Bettis R, Munk ZM, et al. Effectiveness of short-course therapy (5 days) with grepafloxacin in the treatment of acute bacterial exacerbations of chronic bronchitis. Clin Ther. 1999;21:172-188.
41. Topkis S, Swarz H, Breisch SA, et al. Efficacy and safety of grepafloxacin 600 mg daily for 10 days in patients with community-acquired pneumonia. Clin Ther. 1997;19:975-988.
42. Lode H, Vogel F, Elies W. Grepafloxacin: a review of its safety profile based on clinical trials and postmarketing surveillance. Clin Ther. 1999;21:61-74.
43. Stahlmann R, Schwabe R. Safety profile of grepafloxacin compared with other fluoroquinolones. J Antimicrob Chemother. 1997;40 (suppl A):83-92.
44. Ferguson J, Dawe R. Phototoxicity in quinolones: comparison of ciprofloxacin and grepafloxacin. J Antimicrob Chemother. 1997;40 (suppl A):93-98.
45. Rubinstein E. Safety profile of sparfloxacin in the treatment of respiratory tract infections. J Antimicrob Chemother. 1996;37(suppl A):145-160.
46. Lipsky BA, Dorr MB, Magner DJ, et al. Safety profile of sparfloxacin, a new fluoroquinolone antibiotic. Clin Ther. 1999;21:148-159.
47. Finch RG. A review of worldwide experience with sparfloxacin in the treatment of community-acquired pneumonia and acute bacterial exacerbations of chronic bronchitis. Int J Antimicrob Agents. 1999;12:5-17.
48. Jaillon P, Morganroth J, Brumpt I, et al. Overview of electrocardiographic and cardiovascular safety data for sparfloxacin. J Antimicrob Chemother. 1996;37(suppl A):161-167.
49. Williams D, Hopkins S. Safety of trovafloxacin in treatment of lower respiratory tract infections. Eur Clin Microbiol Infect Dis. 1998;17:454-458.
50. Bristol Myers Squibb. Data on file. 1999.
51. Balfour JAB, Wiseman LR. Moxifloxacin. Drugs. 1999;57:363-373.
52. Wise R. A review of the clinical pharmacology of moxifloxacin, a new 8-methoxyquinolone, and its potential relation to therapeutic efficacy. Clin Drug Invest. 1999;17:365-387.
53. von Keutz E, Schluter G. Preclinical safety evaluation of moxifloxacin, a novel fluoroquinolone. J Antimicrob Chemother. 1999;43 (suppl B):91-100.
54. Springsklee M, Reiter C, Meyer JM. Safety and tolerability profile of moxifloxcin (Abstract P0208). 9th European Congress of Clinical Microbiology and Infectious Diseases; 1999; Berlin, Germany.
55. Man I, Murphy J, Ferguson J. Fluoroquinolone phototoxicity: a comparison of moxifloxacin and lomefloxacin in normal volunteers. J Antimicrob Chemother. 1999;43(suppl B):77-82.
56. Snyder RD, Cooper CS. Photogenotoxicity of fluoroquinolones in Chinese hamster V79 cells: dependency on active topoisomerase II. Photochem Photobiol. 1999;69:288-293.
57. Bulera SJ, Theiss JC, Festerling TA, et al. In vitro photogenotoxic activity of clinafloxacin: a paradigm predicting photocarcinogenicity. Toxicol Appl Pharmacol. 1999;156:222-230.
58. Schmuck G, Schurmann A, Schluter G. Determination of the excitatory potencies of fluoroquinolones in the central nervous system by an in vitro model. Antimicrob Agents Chemother. 1998;42:1831-1836.
59. Goldstein EJC. Possible role for the new fluoroquinolones (levofloxacin, grepafloxacin, trovafloxacin, clinafloxacin, sparfloxacin, and DU-6859a) in the treatment of anaerobic infections: Review of current information on efficacy and safety. Clin Infect Dis. 1996;23 (suppl 1):S25-S30.
60. Tanaka M, Kurata T, Fujusawa C, et al. Mechanistic study of inhibition of levofloxacin absorption by aluminum hydroxide. Antimicrob Agents Chemother. 1993;37:2173-2178.
61. Shiba K, Sakai O, Shimada J, et al. Effects of antacids, ferrous sulfate, and ranitidine on absorption of DR-3355 in humans. Antimicrob Agents Chemother. 1992;36:2271-2274.
62. Shiba K, Okazaki O, Aoki H, et al. Influence of antacids and ranitidine on the absorption of levofloxacin in men. Drugs. 1993;45(suppl 3):299-300.
63. Johnson RD, Dorr MB, Talbot GH, et al. Effect of Maalox on the oral absorption of sparfloxacin. Clin Ther. 1998;20:1149-1158.
64. Lober S, Ziege S, Rau M, et al. Pharmacokinetics of gatifloxacin and interaction with an antacid containing aluminum and magnesium. Antimicrob Agents Chemother. 1999;43: 1067-1071.
65. Mignot A, Douin MJ, Millerioux L, et al. The effects of aluminum hydroxide antacid on the pharmacokinetics of the new quinolone sparfloxacin. In: Program and abstracts of the 30th Interscience Conference on Antimicrobial Agents and Chemotherapy; October 21-24, 1990; Atlanta. Abstract 1250.
66. Teng R, Dogolo LC, Willavize SA, et al. Effect of Maalox and omeprazole on the bioavailability of trovafloxacin. J Antimicrob Chemother. 1997;39(suppl B):93-97.
67. Lee LJ, Hafkin B, Lee JD, et al. Effect of food and sucralfate on a single oral dose of 500 milligrams of levofloxacin in healthy subjects. Antimicrob Agents Chemother. 1997;41:2196-2200.
68. Zix JA, Geerdes-Fenge HF, Rau M, et al. Pharmacokinetics of sparfloxacin and interaction with cisapride and sucralfate. Antimicrob Agents Chemother. 1997;41:1668-1672.
69. Kanemitsu K, Hori S, Yanagawa A, et al. Effect of ferrous sulfate on the absorption of sparfloxacin in healthy volunteers and rats. Drugs. 1996;49(suppl 2):352-356.
70. Vincent J, Hunt T, Teng R, et al. The pharmacokinetic effects of coadministration of morphine and trovafloxacin in healthy subjects. Am J Surg. 1998;176(suppl 6A):32S-38S.
71. Efthymiopoulos C, Bramer SL, Maroli A. Effect of food and gastric pH on the bioavailability of grepafloxacin. Clin Pharmacokinet. 1997;33(suppl 1):18-24.
72. Efthymiopoulos C, Bramer SL, Maroli A, et al. Theophylline and warfarin interaction studies with grepafloxacin. Clin Pharmacokinet. 1997;33(suppl 1):39-46.
73. Randinitis EJ, Koup JR, Rausch G, et al. Effect of clinafloxacin administration on the single dose pharmacokinetics of theophylline and caffeine. In: Program and abstracts of the 38th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 24-27, 1998; San Diego. Abstract A-19.
74. Gisclon LG, Curtin CR, Fowler CL, et al. Absence of a pharmacokinetic interaction between intravenous theophylline and orally administered levofloxacin. J Clin Pharmacol. 1997;37:744-750.
75. Niki Y, Hashiguchi K, Okimoto N, et al. Quinolone antimicrobial agents and theophylline. Chest. 1992;101:881.
76. Okimoto N, Niki Y, Soejima R. Effect of levofloxacin on serum concentrations of theophylline. Chemotherapy. 1992;40(suppl3):68-74.
77. Mignot A, Seelmann R, Gottschalk B, et al. No effect of sparfloxacin on the metabolism of theophylline in man. In: Program and abstracts of the 30th Interscience Conference on Antimicrobial Agents and Chemotherapy; October 21-24, 1990; Atlanta. Abstract.
78. Okimoto N, Niki Y, Sumi M, et al. Effect of sparfloxacin on plasma concentrations of theophylline. Chemotherapy. 1991;39(Suppl 4): 366-377.
79. Takagi K, Yamaki K, Nadai M, et al. Effect of a new quinolone, sparfloxacin, on the pharmacokinetics of theophylline in asthmatic patients. Antimicrob Agents Chemother. 1991; 35:1137-1141.
80. Vincent J, Teng R, Dogolo LC, et al. Effect of trovafloxacin, a new fluoroquinoione antibiotic, on the steady-state pharmacokinetics of theophylline in healthy volunteers. J Antimicrob Chemother. 1997;39(suppl B):81-86.
81. Dickens GR, Wermeling D, Vincent J. Phase I pilot study of the effects of trovafloxacin (CP-99,219) on the pharmacokinetics of theophylline in healthy men. J Clin Pharmacol. 1997;37:248-252.
82. Liao S, Palmer M, Fowler CA, et al. Absence of an effect of levofloxacin on warfarin pharmacokinetics and anticoagulation in male volunteers. J Clin Pharmacol. 1996;36:1072-1077.
83. Teng R, Apseloffl G, Vincent J, et al. Effect of trovafloxacin (CP-99,219) on the pharmacokinetics and pharmacodynamics of warfarin in healthy male subjects. In: Program and abstracts of the 36th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 15-18, 1996; New Orleans. Abstract A2.
84. Goel K, Menzies D, Cunha BA. Elevated international normalized ratio associated with trovafloxacin. Ann Intern Med. 1999 ;131:72.
85. Randinitis EJ, Koup JR, Bron NJ, et al. Drug interaction studies of clinafloxacin and probenecid, cimetidine, phenytoin, and warfarin. In: Program and abstracts of the 38th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 24-27, 1998; San Diego. Abstract A-20.
86. Doose DR, Walker SA, Chien SC, et al. Levofloxacin does not alter cyclosporin disposition. J Clin Pharmacol. 1998;38:90-93.
87. Chien SC, Chow AT, Williams R, et al. Absence of an effect of levofloxacin on digoxin pharmacokinetics. In: Program and abstracts of the Annual Meeting Program Supplement; June 5-6, 1995; New Brunswick, NJ. Abstract.
88. Goodwin SD, Gallis HA, Chow AT, et al. Pharmacokinetics and safety of levofloxacin in patients with human immunodeficiency virus infection. Antimicrob Agents Chemother. 1994;38:799-804.
89. Chien SC, Chow AT, Rogge MC, et al. Pharmacokinetics and safety of oral levofloxacin in human immunodeficiency virus-infected individuals receiving concomitant zidovudine. Antimicrob Agents Chemother. 1997;41:1765-1769.
90. Patterson BE, Kleinermans D, Brown SJ, et al. Effects of orally administered trovafloxacin on the steady-state pharmacokinetics of digoxin: results of double-blind, placebo-controlled, parallel group study. In: Proceedings of the International Congress of Infectious Diseases; June 10-13, 1996; Hong Kong. Abstract 70.022.
91. Gaitonde ME, Mendes P, House ESA, et al. The effects of cimetidine and probenecid on the pharmacokinetics of levofloxacin. In: Program and abstracts of the 35th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 17-29, 1995; San Francisco. Abstract A41.
92. Gries JM, Nonorato J, Taburet AM, et al. Cimetidine does not alter sparfloxacin pharmacokinetics. Int J Clin Pharmacol Ther. 1995; 33:585-587.
93. Patterson BE, Pukins L, Oliver SJ, et al. An open, placebo-controlled, two-way crossover study to investigatre the effects of cimetidine on the steady-state pharmacokinetics of trovafloxacin. In: Proceedings of the International Congress of Infectious Diseases; June 10-13, 1996; Hong Kong. Abstract 71.019.