The safety of antimicrobials for the treatment of community-acquired pneumonia

References

• Xu J, Murphy SL, Kochanek KD, et al. Deaths: final data for 2013. Natl Vital Stat Rep. 2016;64(2):1–119.
   PubMedGoogle Scholar
• Torres A, Barberán J, Falguera M, et al., Guía multidisciplinar para la valoración pronóstica, diagnóstico y tratamiento de la neumonía adquirida en la comunidad [Multidisciplinary guidelines for the management of community-acquired pneumonia]. Med Clin (Barc). 2013;140(5): 223.e1–223.e19.
   PubMedGoogle Scholar
• Metlay JP, Waterer GW, Long AC, et al., Diagnosis and treatment of adults with community-acquired pneumonia. An official clinical practice guideline of the American Thoracic Society and Infectious Diseases Society of America. Am J Respir Crit Care Med. 2019;200(7): e45–67.
   PubMed Web of Science ®Google Scholar
• National Institute for Health and Care Excellence Guideline [Internet]. Pneumonia (community-acquired): antimicrobial prescribing; September 2019 [cited 2019 Dec 15]; Available from: https://www.nice.org.uk/guidance/ng138
   Google Scholar
• Hansen MP, Scott AM, McCullough A, et al. Adverse events in people taking macrolide antibiotics versus placebo for any indication. Cochrane Database Syst Rev. 2019;1:CD011825.
   PubMed Web of Science ®Google Scholar
• Pantomicina® SPC [Internet]. Amdipharm Limited; 1982 [cited 2019 Dec 15]; Available from: https://cima.aemps.es/cima/dochtml/ft/55771/FT_55771.html
   Google Scholar
• Klacid® SPC [Internet]. Pfizer; 1994 [cited 2019 Dec 15]; Available from: https://cima.aemps.es/cima/dochtml/ft/60515/FT_60515.html
   Google Scholar
• Zitromax® SPC [Internet]. Mylan Ire Healthcare Limited; 1996 [cited 2019 Dec 15]; Available from: https://cima.aemps.es/cima/dochtml/ft/61272/FT_61272.html
   Google Scholar
• Mensa J, Soriano A, García-Sánchez J, et al. Guía de Terapéutica Antimicrobiana 2019. 29a ed. Barcelona: Antares; 2019.
   Google Scholar
• Van Bambeke F, Tulkens PM. Macrolides: pharmacokinetics and pharmacodynamics. Int J Antimicrob Agents. 2001;18(SUPPL.1):17–23.
   Google Scholar
• Pérez-Trallero E, Martín-Herrero JE, Mazón A, et al. Antimicrobial resistance among respiratory pathogens in Spain: latest data and changes over 11 years (1996–1997 to 2006–2007). Antimicrob Agents Chemother. 2010;54(7):2953–2959.
   PubMed Web of Science ®Google Scholar
• Eljaaly K, Botaish A, Bahobail F, et al. Systematic review and meta-analysis of the safety of erythromycin compared to clarithromycin in adults and adolescents with pneumonia. J Chemother. 2020;32(1):1–6.
   PubMed Web of Science ®Google Scholar
• Abu-Gharbieh E, Vasina V, Poluzzi E, et al. Antibacterial macrolides: a drug class with a complex pharmacological profile. Pharmacol Res. 2004;50(3):211–222.
   PubMed Web of Science ®Google Scholar
• Woodhead JL, Yang K, Oldach D, et al. Analyzing the mechanisms behind macrolide antibiotic-induced liver injury using quantitative systems toxicology modeling. Pharm Res. 2019;36(3). doi: 10.1007/s11095-019-2582-y.
   PubMed Web of Science ®Google Scholar
• Owens RC. QT prolongation with antimicrobial agents: understanding the significance. Drugs. 2004;64(10):1091–1242004.
   PubMed Web of Science ®Google Scholar
• Wong AYS, Chan EW, Anand S, et al. Managing cardiovascular risk of macrolides: systematic review and meta-analysis. Drug Saf. 2017;40(8):663–677.
   PubMed Web of Science ®Google Scholar
• Veiga RP, Paiva J-A. Pharmacokinetics-pharmacodynamics issues relevant for the clinical use of beta-lactam antibiotics in critically ill patients. Crit Care. 2018;22(1):223.
   PubMed Web of Science ®Google Scholar
• Sinnollareddy MG, Roberts MS, Lipman J, et al. β-lactam pharmacokinetics and pharmacodynamics in critically ill patients and strategies for dose optimization: a structured review. Clin Exp Pharmacol Physiol. 2012;39(6):489–496.
   PubMed Web of Science ®Google Scholar
• Leone S, Cascella M, Pezone I, et al. New antibiotics for the treatment of serious infections in intensive care unit patients. Curr Med Res Opin. 2019;35(8):1331–1334.
   PubMed Web of Science ®Google Scholar
• Park MA, Li JTC. Diagnosis and management of penicillin allergy. Mayo Clin Proc. 2005;80(3):405–102005. Elsevier Ltd.
   PubMed Web of Science ®Google Scholar
• Lagacé-Wiens P, Rubinstein E. Adverse reactions to β-lactam antimicrobials. Expert Opin Drug Saf. 2012;11(3):381–992012.
   PubMed Web of Science ®Google Scholar
• Yates AB. Management of patients with a history of allergy to beta-lactam antibiotics. Am J Med. 2008;121(7):572–576.
   PubMed Web of Science ®Google Scholar
• Chiriac AM, Rerkpattanapipat T, Bousquet PJ, et al. Optimal step doses for drug provocation tests to prove beta-lactam hypersensitivity. Allergy Eur J Allergy Clin Immunol. 2017;72(4):552–561.
   Web of Science ®Google Scholar
• Fonacier L, Hirschberg R, Gerson S. Adverse drug reactions to a cephalosporins in hospitalized patients with a history of penicillin allergy. Allergy Asthma Proc. 2005;26(2):135–141.
   PubMed Web of Science ®Google Scholar
• Daulat S, Solensky R, Earl HS, et al. Safety of cephalosporin administration to patients with histories of penicillin allergy. J Allergy Clin Immunol. 2004;113(6):1220–1222.
   PubMed Web of Science ®Google Scholar
• Zagursky RJ, Pichichero ME. Cross-reactivity in β-lactam allergy. J Allergy Clin Immunol Pract. 2018;6(1):72–81.e1.
   PubMed Web of Science ®Google Scholar
• Suárez C, Gudiol F. Beta-lactam antibiotics. Enferm Infecc Microbiol Clin. 2009;27(2):116–129.
   PubMed Web of Science ®Google Scholar
• Sutter R, Rüegg S, Tschudin-Sutter S. Seizures as adverse events of antibiotic drugs: a systematic review. Neurology. 2015;85(15):1332–1341.
   PubMed Web of Science ®Google Scholar
• Tune BM. Nephrotoxicity of beta-lactam antibiotics: mechanisms and strategies for prevention. Pediatr Nephrol. 1997;11(6):768–772.
   PubMed Web of Science ®Google Scholar
• Dekant W, Vamvakas S. Biotransformation and membrane transport in nephrotoxicity. Crit Rev Toxicol. 1996;26(3):309–334.
   PubMed Web of Science ®Google Scholar
• Hammond DA, Smith MN, Li C, et al. systematic review and meta-analysis of acute kidney injury associated with concomitant vancomycin and piperacillin/tazobactam. Clin Infect Dis. 2017;64(5):666–674.
   PubMed Web of Science ®Google Scholar
• Olsen S, Asklund M. Interstitial nephritis with acute renal failure following cardiac surgery and treatment with methicillin. Acta Med Scand. 1976;199(4):305–310.
   PubMedGoogle Scholar
• Onorato IM, Axelrod JL. Hepatitis from intravenous high-dose oxacillin therapy: findings in an adult inpatient population. Ann Intern Med. 1978;89(4):497–500.
   PubMed Web of Science ®Google Scholar
• Shiffman ML, Keith FB, Moore EW. Pathogenesis of ceftriaxone-associated biliary sludge. In vitro studies of calcium-ceftriaxone binding and solubility. Gastroenterology. 1990;99(6):1772–1778.
   PubMed Web of Science ®Google Scholar
• Correia S, Poeta P, Hébraud M, et al. Mechanisms of quinolone action and resistance: where do we stand? J Med Microbiol. 2017;66(5):551–559.
   PubMed Web of Science ®Google Scholar
• Baycip® SPC [Internet]. Bayer Hispania S.L.; 1988 [cited 2019 Dec 20]; Available from: https://cima.aemps.es/cima/dochtml/ft/57973/FT_57973.html
   Google Scholar
• Stein GE. Pharmacokinetics and pharmacodynamics of newer fluoroquinolones. Clin Infect Dis. 1996;23(Suppl 1):S19–24.
   PubMed Web of Science ®Google Scholar
• Fitton A. The quinolones: an overview of their pharmacology. Clin Pharmacokinet. 1992;22(Supplement 1):1–11.
   PubMedGoogle Scholar
• Forrest A, Nix DE, Ballow CH, et al. Pharmacodynamics of intravenous ciprofloxacin in seriously ill patients. Antimicrob Agents Chemother. 1993;37(5):1073–1081.
   PubMed Web of Science ®Google Scholar
• Zelenitsky SA, Ariano RE. Support for higher ciprofloxacin AUC24/MIC targets in treating enterobacteriaceae bloodstream infection. J Antimicrob Chemother. 2010;65(8):1725–1732.
   PubMed Web of Science ®Google Scholar
• Drusano GL, Preston SL, Fowler C, et al. Relationship between fluoroquinolone area under the curve: minimum inhibitory concentration ratio and the probability of eradication of the infecting pathogen, in patients with nosocomial pneumonia. J Infect Dis. 2004;189(9):1590–1597.
   PubMed Web of Science ®Google Scholar
• Ambrose PG, Grasela DM, Grasela TH, et al. Pharmacodynamics of fluoroquinolones against Streptococcus pneumoniae in patients with community-acquired respiratory tract infections. Antimicrob Agents Chemother. 2001;45(10):2793–2797.
   PubMed Web of Science ®Google Scholar
• Alós J-I. Quinolones. Enferm Infecc Microbiol Clin. 2009;27(5):290–297.
   PubMed Web of Science ®Google Scholar
• Owens RC, Ambrose PG. Antimicrobial safety: focus on fluoroquinolones. Clin Infect Dis. 2005;41(Suppl 2):S144–57.
   PubMed Web of Science ®Google Scholar
• Hooper DC, Wolfson JS, Hooper DC. Fluoroquinolone antimicrobial agents. N Engl J Med. 1991;324(6):384–394.
   PubMed Web of Science ®Google Scholar
• Etminan M, Brophy JM, Samii A. Oral fluoroquinolone use and risk of peripheral neuropathy: a pharmacoepidemiologic study. Neurology. 2014;83(14):1261–1263.
   PubMed Web of Science ®Google Scholar
• Gorelik E, Masarwa R, Perlman A, et al. Fluoroquinolones and cardiovascular risk: a systematic review, meta-analysis and network meta-analysis. Drug Saf. 2019;42(4):529–538.
   PubMed Web of Science ®Google Scholar
• Leone R, Venegoni M, Motola D, et al. Adverse drug reactions related to the use of fluoroquinolone antimicrobials: an analysis of spontaneous reports and fluoroquinolone consumption data from three italian regions. Drug Saf. 2003;26(2):109–120.
   PubMed Web of Science ®Google Scholar
• Daneman N, Lu H, Redelmeier DA. Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study. BMJ Open. 2015;5(11):e010077.
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration Drug Safety Communication [Internet]. Fluoroquinolone antibiotic use; Dec 2016 [cited 2019 Dec 25]; Available from: https://www.fda.gov/media/97602/download
   Google Scholar
• European Medicines Agency [Internet]. Press release: disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics; 2018 Nov [cited 2019 Dec 25]; Available from: https://www.ema.europa.eu/en/news/disabling-potentially-permanent-side-effects-lead-suspension-restrictions-quinolone-fluoroquinolone
   Google Scholar
• Zhanel GG, Homenuik K, Nichol K, et al. the glycylcyclines: a comparative review with the tetracyclines. Drugs. 2004;64(1):63–882004.
   PubMed Web of Science ®Google Scholar
• Nuzyra® SPC [Internet]. Paratek Pharms Inc; 2018 [cited 2019 Dec 15]; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209816_209817lbl.pdf
   Google Scholar
• Vicente D, Pérez-Trallero E. Tetraciclinas, sulfamidas y metronidazol. Enferm Infecc Microbiol Clin. 2010;28(2):122–130.
   PubMed Web of Science ®Google Scholar
• Agwuh KN. Pharmacokinetics and pharmacodynamics of the tetracyclines including glycylcyclines. J Antimicrob Chemother. 2006;58(2):256–265.
   PubMed Web of Science ®Google Scholar
• Bhavnani SM, Rubino CM, Hammel JP, et al. Pharmacological and patient-specific response determinants in patients with hospital-acquired pneumonia treated with tigecycline. Antimicrob Agents Chemother. 2012;56(2):1065–1072.
   PubMed Web of Science ®Google Scholar
• Gallego Úbeda M, Delgado Téllez De Cepeda L, Campos Fernández De Sevilla MDLA, et al. Actualización del uso de fármacos durante el embarazo: categorías de riesgo. Farmacia Hospitalaria. 2014;38(4):364–378. Sociedad Espanola de Farmacia Hospitalaria.
   Google Scholar
• Tygacil® SPC [Internet]. Pfizer Europe MA EEIG; 2006 [cited 2019 Dec 20]; Available from: https://cima.aemps.es/cima/dochtml/ft/06336001/FT_06336001.html#4-8-reacciones-adversas
   Google Scholar
• Hamilton LA, Guarascio AJ. Tetracycline allergy. Pharmacy. 2019;7(3):104.
   Web of Science ®Google Scholar
• Heaton PC, Fenwick SR, Brewer DE. Association between tetracycline or doxycycline and hepatotoxicity: a population based case-control study. J Clin Pharm Ther. 2007;32(5):483–487.
   PubMed Web of Science ®Google Scholar
• Xenleta® SPC [Internet]. Nabriva Therapeutics; 2019 [cited 2019 Dec 15]; Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211672s000,211673s000lbl.pdf
   Google Scholar
• Veve MP, Wagner JL. Lefamulin: review of a promising novel pleuromutilin antibiotic. Pharmacotherapy. 2018;38(9):935–462018. Pharmacotherapy Publications Inc.
   PubMed Web of Science ®Google Scholar
• Pakhale S, Mulpuru S, Verheij TJM, et al. Antibiotics for community-acquired pneumonia in adult outpatients. Cochrane Database Syst Rev. 2014. John Wiley and Sons Ltd. doi: 10.1002/14651858.CD002109.pub4
   PubMed Web of Science ®Google Scholar
• Paris R, Confalonieri M, Dal Negro R, et al. Efficacy and safety of azithromycin 1 g once daily for 3 days in the treatment of community-acquired pneumonia: an open-label randomised comparison with amoxicillin-clavulanate 875/125 mg twice daily for 7 days. J Chemother. 2008;20(1):77–86.
   PubMed Web of Science ®Google Scholar
• Skalsky K, Yahav D, Lador A, et al. Macrolides vs. quinolones for community-acquired pneumonia: meta-analysis of randomized controlled trials. Clin Microbiol Infect. 2013;19(4):370–378.
   PubMed Web of Science ®Google Scholar
• Eliakim-Raz N, Robenshtok E, Shefet D, et al. Empiric antibiotic coverage of atypical pathogens for community-acquired pneumonia in hospitalized adults. Cochrane Database Syst Rev. 2012. doi: 10.1002/14651858.CD004418.pub4.
   PubMed Web of Science ®Google Scholar
• Raz-Pasteur A, Shasha D, Paul M. Fluoroquinolones or macrolides alone versus combined with β-lactams for adults with community-acquired pneumonia: systematic review and meta-analysis. Int J Antimicrob Agents. 2015;46(3):242–82015. Elsevier B.V.
   PubMed Web of Science ®Google Scholar
• Rodríguez-Baño J, Paño-Pardo JR, Alvarez-Rocha L, et al. Programs for optimizing the use of antibiotics (PROA) in Spanish hospitals: GEIH-SEIMC, SEFH and SEMPSPH consensus document. Farm Hosp. 2012;36(1):33.e1–30.
   PubMedGoogle Scholar
• Howard RL, Avery AJ, Slavenburg S, et al. Which drugs cause preventable admissions to hospital? A systematic review. Br J Clin Pharmacol. 2007;63(2):136–147.
   PubMed Web of Science ®Google Scholar
• Sultana J, Cutroneo P, Trifirò G. Clinical and economic burden of adverse drug reactions. J Pharmacol Pharmacother. 2013;4(5):73.
   PubMedGoogle Scholar