Adverse Events Associated with Fosfomycin Use: Review of the Literature and Analyses of the FDA Adverse Event Reporting System Database
Tóm tắt
Từ khóa
Tài liệu tham khảo
MONUROL® (fosfomycin tromethamine) SACHET. http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050717s007lbl.pdf . Accessed March 7, 2011.
Michalopoulos AS, Livaditis IG, Gougoutas V. The revival of fosfomycin. Int J Infect Dis. 2011;15(11):e732–9.
Falagas ME, Kastoris AC, Kapaskelis AM, Karageorgopoulos DE. Fosfomycin for the treatment of multidrug-resistant, including extended-spectrum beta-lactamase producing, Enterobacteriaceae infections: a systematic review. Lancet Infect Dis. 2010;10(1):43–50.
Samonis G, Maraki S, Rafailidis PI, Kapaskelis A, Kastoris AC, Falagas ME. Antimicrobial susceptibility of Gram-negative nonurinary bacteria to fosfomycin and other antimicrobials. Future Microbiol. 2010;5(6):961–70.
Perdigão-Neto LV, Oliveira MS, Rizek CF, Carrilho CM, Costa SF, Levin AS. Susceptibility of multiresistant gram-negative bacteria to fosfomycin and performance of different susceptibility testing methods. Antimicrob Agents Chemother. 2014;58(3):1763–7
Falagas ME, Giannopoulou KP, Kokolakis GN, Rafailidis PI. Fosfomycin: use beyond urinary tract and gastrointestinal infections. Clin Infect Dis. 2008;46(7):1069–77.
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(6):381–92.
Medical Dictionary for Regulatory Activities Maintenance and Support Services Organization [online]. http://www.meddramsso.com/ . Accessed March 7, 2011.
Reporting adverse drug reactions, Definitions of Terms and Criteria for their Use. Council for International Organizations of Medical Sciences (CIOMS). 2000.
Nohr M, Andersen JC, Juul-Jensen KE. Prophylactic single-dose fosfomycin and metronidazole compared with neomycin, bacitracin, metronidazole and ampicillin in elective colorectal operations. Acta Chir Scand. 1990;156(3):223–30.
Corti N, Sennhauser FH, Stauffer UG, Nadal D. Fosfomycin for the initial treatment of acute haematogenous osteomyelitis. Arch Dis Child. 2003;88(6):512–6.
Nissen LR, Jacobsen J, Ravn TJ, Wahlgreen C, Auning-Hansen H. Fosfomycin-ampicillin versus gentamicin-ampicillin in the treatment of critically ill patients with pneumonia. Infection. 1986;14(5):246–9.
Ishizaka K, Kobayashi S, Machida T, Yoshida K. Randomized prospective comparison of fosfomycin and cefotiam for prevention of postoperative infection following urological surgery. J Infect Chemother. 2007;13(5):324–31.
Chareancholvanich K, Udomkiat P, Waikakul S. A randomized control trial between fosfomycin and cefuroxime as the antibiotic prophylaxis in knee arthroplasty. J Med Assoc Thai. 2012;95(Suppl 9):S6–13.
Andaker L, Burman LG, Eklund A, et al. Fosfomycin/metronidazole compared with doxycycline/metronidazole for the prophylaxis of infection after elective colorectal surgery. A randomised double-blind multicentre trial in 517 patients. Eur J Surg. 1992;158(3):181–5.
Lindhagen J, Hadziomerovic A, Nordlung S, Zbornik J. Comparison of systemic prophylaxis with metronidazole-fosfomycin and metronidazole-cephalothin in elective colorectal surgery. Acta Chir Scand. 1981;147(4):277–83.
Sirijatuphat R, Thamlikitkul V. Preliminary study of colistin versus colistin plus fosfomycin for treatment of carbapenem-resistant Acinetobacter baumannii infections. Antimicrob Agents Chemother. 2014;58(9):5598–601.
Portier H, Kazmierczak A, Lucht F, Tremeaux JC, Chavanet P, Duez JM. Cefotaxime in combination with other antibiotics for the treatment of severe methicillin-resistant staphylococcal infections. Infection. 1985;13(Suppl 1):S123–8.
Mirakhur A, Gallagher MJ, Ledson MJ, Hart CA, Walshaw MJ. Fosfomycin therapy for multiresistant Pseudomonas aeruginosa in cystic fibrosis. J Cyst Fibros. 2003;2(1):19–24.
Meissner A, Haag R, Rahmanzadeh R. Adjuvant fosfomycin medication in chronic osteomyelitis. Infection. 1989;17(3):146–51.
Stengel D, Gorzer E, Schintler M, et al. Second-line treatment of limb-threatening diabetic foot infections with intravenous fosfomycin. J Chemother. 2005;17(5):527–35.
Michalopoulos A, Virtzili S, Rafailidis P, Chalevelakis G, Damala M, Falagas ME. Intravenous fosfomycin for the treatment of nosocomial infections caused by carbapenem-resistant Klebsiella pneumoniae in critically ill patients: a prospective evaluation. Clin Microbiol Infect. 2010;16(2):184–6.
Florent A, Chichmanian RM, Cua E, Pulcini C. Adverse events associated with intravenous fosfomycin. Int J Antimicrob Agents. 2011;37(1):82–3.
Hutzler R, Fernandes V, Munoz D, Rozentraub A. Activity of fosfomycin in the treatment of bacterial infections. Chemotherapy. 1977;23(Suppl 1):358–64.
Llorens J, Ley G, Fores A, Olay T. Acute infantile pneumonopathies treated with fosfomycin. Chemotherapy. 1977;23(Suppl 1):315–23.
Hernandez Casado V. Fosfomycin in a traumatological department. Chemotherapy. 1977;23(Suppl 1):403–10.
Menendez A, Tutor A, Sousa AS. Treatment of respiratory infections with fosfomycin. Chemotherapy. 1977;23(Suppl 1):348–57.
Gallardo A, Saez JM, Enriquez G, et al. Surgical suppurating infections and surgical abdominal infections treated with fosfomycin. Chemotherapy. 1977;23(Suppl 1):392–8.
Baquero F, Hortelano JG, Navarro M, et al. Antibiotherapy of Serratia marcescens septicemia in children. Chemotherapy. 1977;23(Suppl 1):416–22.
Ruiz Garcia A, de la Lastra AM, Garzon JM, Reig M, Rodriguez A. Fosfomycin in puerperal infections and its elimination in lochia. Chemotherapy. 1977;23(Suppl 1):281–6.
Pontikis K, Karaiskos I, Bastani S, et al. Outcomes of critically ill intensive care unit patients treated with fosfomycin for infections due to pandrug-resistant and extensively drug-resistant carbapenemase-producing Gram-negative bacteria. Int J Antimicrob Agents. 2014;43(1):52–9.
del Rio A, Gasch O, Moreno A, et al. Efficacy and safety of fosfomycin plus imipenem as rescue therapy for complicated bacteremia and endocarditis due to methicillin-resistant Staphylococcus aureus: a multicenter clinical trial. Clin Infect Dis. 2014;59(8):1105–12.
Rudenko N, Dorofeyev A. Prevention of recurrent lower urinary tract infections by long-term administration of fosfomycin trometamol. Double blind, randomized, parallel group, placebo controlled study. Arzneimittelforschung. 2005;55(7):420–7.
Costantini E, Zucchi A, Salvini E, et al. Prulifloxacin vs fosfomycin for prophylaxis in female patients with recurrent UTIs: a non-inferiority trial. Int Urogynecol J. 2014;25(9):1173–8.
Naber KG, Thyroff-Friesinger U. Fosfomycin trometamol versus ofloxacin/co-trimoxazole as single dose therapy of acute uncomplicated urinary tract infection in females: a multicentre study. Infection. 1990;18(Suppl 2):S70–6.
Zinner S. Fosfomycin trometamol versus pipemidic acid in the treatment of bacteriuria in pregnancy. Chemotherapy. 1990;36(Suppl 1):50–2.
Boerema JB, Willems FT. Fosfomycin trometamol in a single dose versus norfloxacin for seven days in the treatment of uncomplicated urinary infections in general practice. Infection. 1990;18(Suppl 2):S80–8.
Cooper J, Raeburn A, Brumfitt W, Hamilton-Miller JM. Single dose and conventional treatment for acute bacterial and non-bacterial dysuria and frequency in general practice. Infection. 1990;18(2):65–9.
Selvaggi FP, Ditonno P, Traficante A, Battaglia M, Di Lorenzo V. Fosfomycin trometamol (Monuril) versus norfloxacin in single dose for adult female uncomplicated UTIs. Multicenter randomized, double-blind study. Chemotherapy. 1990;36(Suppl 1):31–3.
Crocchiolo P. Single-dose fosfomycin trometamol versus multiple-dose cotrimoxazole in the treatment of lower urinary tract infections in general practice. Multicenter Group of General Practitioners. Chemotherapy. 1990;36(Suppl 1):37–40.
Baert L, Billiet I, Vandepitte J. Prophylactic chemotherapy with fosfomycin trometamol versus placebo during transurethral prostatic resection. Infection. 1990;18(Suppl 2):S103–6.
Reynaert J, Van Eyck D, Vandepitte J. Single dose fosfomycin trometamol versus multiple dose norfloxacin over three days for uncomplicated UTI in general practice. Infection. 1990;18(Suppl 2):S77–9.
Ferraro G, Ambrosi G, Bucci L, Palmieri R, Palmieri G. Fosfomycin trometamol versus norfloxacin in the treatment of uncomplicated lower urinary tract infections of the elderly. Chemotherapy. 1990;36(Suppl 1):46–9.
Principi N, Corda R, Bassetti D, Varese LA, Peratoner L. Fosfomycin trometamol versus netilmicin in children’s lower urinary tract infections. Chemotherapy. 1990;36(Suppl 1):41–5.
Caramalli S, Amprimo MC, Cavalli G, et al. Effect and pharmacokinetics of netilmicin given as bolus intramuscular administration: an open comparative trial versus amikacin and fosfomycin in elderly patients affected by urinary tract infections. Int J Clin Pharmacol Res. 1991;11(2):55–65.
de Jong Z, Pontonnier F, Plante P. Single-dose fosfomycin trometamol (Monuril) versus multiple-dose norfloxacin: results of a multicenter study in females with uncomplicated lower urinary tract infections. Urol Int. 1991;46(4):344–8.
Van Pienbroek E, Hermans J, Kaptein AA, Mulder JD. Fosfomycin trometamol in a single dose versus seven days nitrofurantoin in the treatment of acute uncomplicated urinary tract infections in women. Pharm World Sci. 1993;15(6):257–62.
Elhanan G, Tabenkin H, Yahalom R, Raz R. Single-dose fosfomycin trometamol versus 5-day cephalexin regimen for treatment of uncomplicated lower urinary tract infections in women. Antimicrob Agents Chemother. 1994;38(11):2612–4.
Careddu P, Borzani M, Scotti L, Varotto F, Garlaschi L, Fontana P. Treatment of lower urinary tract infections in children: single dose fosfomycin trometamol versus pipemidic acid. Chemioterapia. 1987;6(4):290–4.
Varese LA. Trometamol salt of fosfomycin versus netilmicin: randomized multicenter study in children’s lower urinary tract infections. Eur Urol. 1987;13(Suppl 1):119–21.
Bayrak O, Cimentepe E, Inegol I, et al. Is single-dose fosfomycin trometamol a good alternative for asymptomatic bacteriuria in the second trimesterof pregnancy? Int Urogynecol J Pelvic Floor Dysfunct. 2007;18(5):525–9.
Estebanez A, Pascual R, Gil V, Ortiz F, Santibanez M, Perez Barba C. Fosfomycin in a single dose versus a 7-day course of amoxicillin–clavulanate for the treatment of asymptomatic bacteriuria during pregnancy. Eur J Clin Microbiol Infect Dis. 2009;28(12):1457–64.
Ceran N, Mert D, Kocdogan FY, et al. A randomized comparative study of single-dose fosfomycin and 5-day ciprofloxacin in female patients with uncomplicated lower urinary tract infections. J Infect Chemother. 2010;16(6):424–30.
Usta TA, Dogan O, Ates U, Yucel B, Onar Z, Kaya E. Comparison of single-dose and multiple-dose antibiotics for lower urinary tract infection in pregnancy. Int J Gynaecol Obstet. 2011;114(3):229–33.
Jardin A. A general practitioner multicenter study: fosfomycin trometamol single dose versus pipemidic acid multiple dose. Infection. 1990;18(Suppl 2):S89–93.
Thoumsin H, Aghayan M, Lambotte R. Single dose fosfomycin trometamol versus multiple dose nitrofurantoin in pregnant women with bacteriuria: preliminary results. Infection. 1990;18(Suppl 2):S94–7.
Lista F, Redondo C, Meilan E, Garcia-Tello A, Ramon de Fata F, Angulo JC. Efficacy and safety of fosfomycin-trometamol in the prophylaxis for transrectal prostate biopsy. Prospective randomized comparison with ciprofloxacin. Actas Urol Esp. 2014;38(6):391–6.
Periti P, Novelli A, Reali EF, Lamanna S, Fontana P. Prophylactic chemotherapy with fosfomycin trometamol salt during transurethral prostatic surgery: a controlled multicenter clinical trial. Eur Urol. 1987;13(Suppl 1):122–31.
Stein GE. Comparison of single-dose fosfomycin and a 7-day course of nitrofurantoin in female patients with uncomplicated urinary tract infection. Clin Ther. 1999;21(11):1864–72.
di Silverio F, Ferrone G, Carati L. Prophylactic chemotherapy with fosfomycin trometamol during transurethral surgery and urological manoeuvres. Results of a multicentre study. Infection. 1990;18(Suppl 2):S98–102.
Falagas ME, Vouloumanou EK, Togias AG, et al. Fosfomycin versus other antibiotics for the treatment of cystitis: a meta-analysis of randomized controlled trials. J Antimicrob Chemother. 2010;65(9):1862–77.
Fujii R. Fosfomycin in the treatment of bacterial infections: summary of clinical trials in Japan. Chemotherapy. 1977;23(Suppl 1):234–46.
Mayama T, Yokota M, Shimatani I, Ohyagi H. Analysis of oral fosfomycin calcium (Fosmicin) side-effects after marketing. Int J Clin Pharmacol Ther Toxicol. 1993;31(2):77–82.
Durupt S, Josserand RN, Sibille M, Durieu I. Acute, recurrent fosfomycin-induced liver toxicity in an adult patient with cystic fibrosis. Scand J Infect Dis. 2001;33(5):391–2.
Wang YP, Shi B, Chen YX, Xu J, Jiang CF, Xie WF. Drug-induced liver disease: an 8-year study of patients from one gastroenterological department. J Dig Dis. 2009;10(3):195–200.
Sanchez-Morillas L, Perez-Ezquerra PR, Reano-Martos M, Mayorga C, Laguna-Martinez JJ. Anaphylaxis induced by fosfomycin. Ann Allergy Asthma Immunol. 2010;105(3):241.
Gamboa PM, Antepara I, Jauregui I, Urrutia I, Sanz ML. Two patients with anaphylactic shock due to fosfomycin. Ann Allergy Asthma Immunol. 2011;106(3):260–1.
Canamares-Orbis I, Silva JT, Lopez-Medrano F, Aguado JM. Is high-dose intravenous fosfomycin safe for the treatment of patients prone to heart failure? Enferm Infecc Microbiol Clin. 2014;. doi: 10.1016/j.eimc.2014.07.005 .
Neu HC. Fosfomycin trometamol versus amoxycillin–single-dose multicenter study of urinary tract infections. Chemotherapy. 1990;36(Suppl 1):19–23.