Comparative safety profile of levofloxacin in 2523 children with a focus on four specific musculoskeletal disorders

Pediatric Infectious Disease Journal

Volumn 26, Issue 10, 2007, Pages 879-891

  Noel, Gary J ^a   Bradley, John S ^b   Kauffman, Ralph E ^c   Duffy, Ciaran M ^d   Gerbino, Peter G ^e   Arguedas, Adriano ^f   Bagchi, Partha ^a   Balis, Dainius A ^a   Blumer, Jeffrey L ^g  

^a JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

^b RADY CHILDREN'S HOSPITAL   (United States)

^c CHILDREN S MERCY HOSPITAL   (United States)

^d MONTREAL CHILDREN S HOSPITAL   (Canada)

^e BOSTON CHILDREN S HOSPITAL   (United States)

^f Instituto de Atencion Pediatrica Costa Rica   (Costa Rica)

^g CASE WESTERN RESERVE UNIVERSITY   (United States)

Author keywords

Children; Fluoroquinolone; Joint pain; Levofloxacin; Musculoskeletal disorder

Indexed keywords

AMOXICILLIN PLUS CLAVULANIC ACID; CEFTRIAXONE; CLARITHROMYCIN; ERYTHROMYCIN LACTOBIONATE; LEVOFLOXACIN;

ABDOMINAL PAIN; ADOLESCENT; ARTHRALGIA; ARTHRITIS; ARTHROPATHY; ARTICLE; BACKACHE; BLOODY DIARRHEA; BUTTOCK PAIN; CHILD; CHONDROPATHY; CLINICAL ASSESSMENT; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORRELATION FUNCTION; DIARRHEA; DIZZINESS; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EXPERIMENTAL ANIMAL; FEBRILE CONVULSION; FEMALE; GAIT DISORDER; HEADACHE; HEMARTHROSIS; HUMAN; HUMAN TISSUE; HYPERACTIVITY; INCIDENCE; INFANT; INFORMATION PROCESSING; IRRITABILITY; LIMB PAIN; MAJOR CLINICAL STUDY; MALE; MONITORING; MULTICENTER STUDY; MUSCLE DISEASE; MUSCLE WEAKNESS; MUSCULOSKELETAL PAIN; MUSCULOSKELETAL SYSTEM; MYALGIA; MYOSITIS; OBSERVATIONAL STUDY; PAIN; PATHOLOGIC FRACTURE; PHASE 3 CLINICAL TRIAL; PHYSICIAN; POLYMYALGIA; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RASH; SHOULDER PAIN; SIDE EFFECT; SOMNOLENCE; STATISTICAL SIGNIFICANCE; SYNOVITIS; TENDINITIS; VOMITING;

ADOLESCENT; ANTI-BACTERIAL AGENTS; BACTERIAL INFECTIONS; CHILD; CHILD, PRESCHOOL; FEMALE; HUMANS; INFANT; MALE; MUSCULOSKELETAL DISEASES; OFLOXACIN; PROSPECTIVE STUDIES;

EID: 34848893647     PISSN: 08913668     EISSN: None     Source Type: Journal    
DOI: 10.1097/INF.0b013e3180cbd382     Document Type: Article

References (19)

1. Stahlmann R, Lode H. Safety overview: toxicity, adverse effects and drug interactions. In: Andriole V, ed. The Qunilones. 3rd ed. San Diego: Academic Press; 2000:397-453.
2. Riecke K, Lozo E, Shakibaei M, Baumann-Wilschke I, Stahlmann R. Fluoroquinolone-induced lesions in the epiphyseal growth plates of immature rats. Paper presented at: Program and abstracts of the 40th Interscience Conference on Antimicrobial Agents and Chemotherapy; 2000; Toronto, Ontario.
3. Stahlmann R. Children as a special population at risk - quinolones as an example for xenobiotics exhibiting skeletal toxicity. Arch Toxicol. 2003;77:7-11.
4. Ingham B, Brentnall DW, Dale EA, McFadzean JA. Arthropathy induced by antibacterial fused N-alkyl-4-pyridone-3-carboxylic acids. Toxicol Lett. 1977;1:21-26.
5. Sanders WE. Adverse reactions to fluoroquinolones. In: Sanders WE, Sanders, CC, eds. Fluoroquinolones in the Treatment of Infectious Diseases. Glenview, IL: Physicians and Scientists Publishing; 1990:233-262.
6. Burkhardt JE, Walterspiel JN, Schaad UB. Quinolone arthropathy in animals versus children. Clin Infect Dis. 1997;5:1196-1204.
7. Yee CL, Duffy C, Gerbino PG, Stryker S, Noel GJ. Tendon or joint disorders in children after treatment with fluoroquinolones or azithromycin. Pediatr Infect Dis J. 2002;21:525-529.
8. Report of the Committee on Infectious Diseases. Red Book. 27 ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006.
9. Chalumeau M, Tonnelier S, D'Athis P, et al. Fluoroquinolone safety in pediatric patients: a prospective, multicenter, comparative cohort study in France. Pediatrics. 2003;111(6, pt 1):e714-e719.
10. Arguedas A, Sher L, Lopez E, et al. Open label, multicenter study of gatifloxacin treatment of recurrent otitis media and acute otitis media treatment failure. Pediatr Infect Dis J. 2003;22:949-956.
11. Leibovitz E, Piglansky L, Raiz S, et al. Bacteriologic and clinical efficacy of oral gatifloxacin for the treatment of recurrent/nonresponsive acute otitis media: an open label, noncomparative, double tympanocentesis study. Pediatr Infect Dis J. 2003;22:943-949.
12. Ernst ME, Ernst EJ, Klepser ME. Levofloxacin and trovafloxacin: the next generation of fluoroquinolones? Am J Health Syst Pharm. 1997;54:2569-2584.
13. Pletz MW, De Roux A, Roth A, Neumann KH, Mauch H, Lode H. Early bactericidal activity of moxifloxacin in treatment of pulmonary tuberculosis: a prospective, randomized study. Antimicrob Agents Chemother. 2004;48:780-782.
14. Food and Drug Administration. Anti-Infective Drugs Advisory Committee Meeting. Bethesda, MD: Food and Drug Administration; March 1997.
15. Grady R. Safety profile of quinolone antibiotics in the pediatric population. Pediatr Infect Dis J. 2003;22:1128-1132.
16. Koyle MA, Barqawi A, Wild J, Passamaneck M, Furness PD III. Pediatric urinary tract infections: the role of fluoroquinolones. Pediatr Infect Dis J. 2003;22:1133-1137.
17. Pichichero ME, Arguedas A, Dagan R, et al. Safety and efficacy of gatifloxacin therapy for children with recurrent acute otitis media (AOM) and/or AOM treatment failure. Clin Infect Dis. 2005;41:470-478.
18. Chien S, Wells TG, Blumer JL, et al. Levofloxacin pharmacokinetics in children. J Clin Pharmacol. 2005;45:153-160.
19. Arguedas A, Dagan R, Pichichero M, et al. An open-label, double tympanocentesis study of levofloxacin therapy in children with, or at high risk for, recurrent or persistent acute otitis media. Pediatr Infect Dis J. 2006;25:1102-1109.