41
Views
0
CrossRef citations to date
0
Altmetric
Original Research

A pharmacovigilance study of adverse events associated with polymyxins based on the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database

, , , , , , & show all
Received 03 Nov 2023, Accepted 19 Mar 2024, Published online: 01 May 2024

References

  • Nang SC, Azad MAK, Velkov T, et al. Rescuing the Last-Line Polymyxins: achievements and challenges. Pharmacol Rev. 2021;73(2):679–728. doi: 10.1124/pharmrev.120.000020
  • Falagas ME, Kasiakou SK, Saravolatz LD. Colistin: the revival of polymyxins for the management of multidrug-resistant gram-negative bacterial infections. Clin Infect Dis. 2005;40(9):1333–1341. doi: 10.1086/429323
  • Sisay M, Hagos B, Edessa D, et al. Polymyxin-induced nephrotoxicity and its predictors: a systematic review and meta-analysis of studies conducted using RIFLE criteria of acute kidney injury. Pharmacol Res. 2021;163:105328. doi: 10.1016/j.phrs.2020.105328
  • Falagas ME, Kasiakou SK. Toxicity of polymyxins: a systematic review of the evidence from old and recent studies. Crit Care. 2006;10(1):R27. doi: 10.1186/cc3995
  • Gunay E, Kaya S, Baysal B, et al. Evaluation of prognosis and nephrotoxicity in patients treated with colistin in intensive care unit. Ren Fail. 2020;42(1):704–709. doi: 10.1080/0886022X.2020.1795878
  • Murray CJL, Ikuta KS, Sharara F. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet. 2022;399(10325):629–655. doi: 10.1016/S0140-6736(21)02724-0
  • Akova M. Epidemiology of antimicrobial resistance in bloodstream infections. Virulence. 2016;7(3):252–266. doi: 10.1080/21505594.2016.1159366
  • Scudeller L, Righi E, Chiamenti M, et al. Systematic review and meta-analysis of in vitro efficacy of antibiotic combination therapy against carbapenem-resistant gram-negative bacilli. Int J Antimicrob Agents. 2021;57(5):106344. doi: 10.1016/j.ijantimicag.2021.106344
  • Ardebili A, Izanloo A, Rastegar M. Polymyxin combination therapy for multidrug-resistant, extensively-drug resistant, and difficult-to-treat drug-resistant gram-negative infections: is it superior to polymyxin monotherapy? Expert Rev Anti Infect Ther. 2023;21(4):387–429. doi: 10.1080/14787210.2023.2184346
  • Katip W, Oberdorfer P, Kasatpibal N. Effectiveness and nephrotoxicity of loading dose colistin–meropenem versus loading dose colistin–imipenem in the treatment of carbapenem-resistant Acinetobacter baumannii infection. Pharmaceutics. 2022;14(6):1266. doi: 10.3390/pharmaceutics14061266
  • Pogue JM, Lee J, Marchaim D, et al. Incidence of and risk factors for colistin-associated nephrotoxicity in a large academic health system. Clin Infect Dis. 2011 Nov;53:(9):879–884.
  • Kubin CJ, Ellman TM, Phadke V, et al. Incidence and predictors of acute kidney injury associated with intravenous polymyxin B therapy. J Infect. 2012;65(1):80–87. doi: 10.1016/j.jinf.2012.01.015
  • Justo JA, Bosso JA. Adverse reactions associated with systemic polymyxin therapy. Pharmacotherapy. 2015;35(1):28–33. doi: 10.1002/phar.1493
  • Doshi NM, Mount KL, Murphy CV. Nephrotoxicity associated with intravenous colistin in critically ill patients. Pharmacotherapy. 2011;31(12):1257–1264. doi: 10.1592/phco.31.12.1257
  • Katip W, Uitrakul S, Oberdorfer P. Clinical efficacy and nephrotoxicity of the loading dose colistin for the treatment of carbapenem-resistant Acinetobacter baumannii in critically Ill patients. Pharmaceutics. 2021;14(1):31. doi: 10.3390/pharmaceutics14010031
  • Katip W, Rayanakorn A, Oberdorfer P, et al. Short versus long course of colistin treatment for carbapenem-resistant A. baumannii in critically ill patients: a propensity score matching study. J Infect Public Health. 2023;16(8):1249–1255. doi: 10.1016/j.jiph.2023.05.024
  • Falagas ME, Rizos M, Bliziotis IA, et al. Toxicity after prolonged (more than four weeks) administration of intravenous colistin. BMC Infect Dis. 2005;5(1):1. doi: 10.1186/1471-2334-5-1
  • Zhang X, Qi S, Duan X, et al. Clinical outcomes and safety of polymyxin B in the treatment of carbapenem-resistant Gram-negative bacterial infections: a real-world multicenter study. J Transl Med. 2021;19(1):431. doi: 10.1186/s12967-021-03111-x
  • Avedissian SN, Scheetz MH. Does renal function matter for polymyxin B? Br J Clin Pharmacol. 2021;87(7):2629–2632. doi: 10.1111/bcp.14675
  • Manchandani P, Thamlikitkul V, Dubrovskaya Y, et al. Population pharmacokinetics of polymyxin B. Clin Pharmacol Ther. 2018;104(3):534–538. doi: 10.1002/cpt.981
  • Oliota AF, Penteado ST, Tonin FS, et al. Nephrotoxicity prevalence in patients treated with polymyxins: a systematic review with meta-analysis of observational studies. Diagn Microbiol Infect Dis. 2019;94(1):41–49. doi: 10.1016/j.diagmicrobio.2018.11.008
  • Quintanilha JCF, Duarte NDC, Lloret GR, et al. Colistin and polymyxin B for treatment of nosocomial infections in intensive care unit patients: pharmacoeconomic analysis. Int J Clin Pharm. 2019;41(1):74–80. doi: 10.1007/s11096-018-0766-x
  • Zou D, Zhang R, Yu L, et al. Seizures associated with antibiotics: a real-world disproportionality analysis of FAERS database. Expert Opin Drug Saf. 2023;22(11):1–6. doi: 10.1080/14740338.2023.2234825
  • Waliany S, Zhu H, Wakelee H, et al. Pharmacovigilance analysis of cardiac toxicities associated with targeted therapies for metastatic NSCLC. J Thorac Oncol. 2021;16(12):2029–2039. doi: 10.1016/j.jtho.2021.07.030
  • Chen C, Wu B, Zhang C, et al. Immune-related adverse events associated with immune checkpoint inhibitors: an updated comprehensive disproportionality analysis of the FDA adverse event reporting system. Int Immunopharmacol. 2021;95:107498. doi: 10.1016/j.intimp.2021.107498
  • Cirmi S, El Abd A, Letinier L, et al. Cardiovascular toxicity of tyrosine kinase inhibitors used in chronic myeloid leukemia: an analysis of the FDA adverse event reporting system database (FAERS). Cancers (Basel). 2020;12(4):826. doi: 10.3390/cancers12040826
  • Qin W, Zhao B, Shang Y, et al. Clinical profile of acute pancreatitis following treatment with protease inhibitors: a real-world analysis of post-marketing surveillance data. Expert Opin Drug Saf. 2021;20(9):1109–1115. doi: 10.1080/14740338.2021.1933942
  • Wagenlehner F, Lucenteforte E, Pea F, et al. Systematic review on estimated rates of nephrotoxicity and neurotoxicity in patients treated with polymyxins. Clin Microbiol Infect. 2021:S1198–743X(20)30764–3. doi: 10.1016/j.cmi.2020.12.009
  • Tsuji BT, Pogue JM, Zavascki AP, et al. International consensus guidelines for the optimal use of the polymyxins: endorsed by the American College of Clinical Pharmacy (ACCP. European Society Of Clinical Microbiology And Infectious Diseases (ESCMID), Infectious Diseases Society Of America (IDSA), International Society For Anti-Infective Pharmacology (ISAP), Society Of Critical Care Medicine (SCCM), And Society Of Infectious Diseases Pharmacists (SIDP). Pharmacother. 2019;39(1):10–39.
  • Avedissian SN, Miglis C, Kubin CJ, et al. Polymyxin B pharmacokinetics in adult cystic fibrosis patients. Pharmacother. 2018;38(7):730–738. doi: 10.1002/phar.2129
  • Lodise TP, Yucel E, Obi EN, et al. Incidence of acute kidney injury (AKI) and its impact on patient outcomes among adult hospitalized patients with carbapenem-resistant Gram-negative infections who received targeted treatment with a newer β-lactam or β-lactam/β-lactamase inhibitor-, polymyxin- or aminoglycoside-containing regimen. J Antimicrob Chemother. 2024;79(1):82–95. doi: 10.1093/jac/dkad351
  • Ning Y, Chu Y, Wu Y, et al. Case report: respiratory paralysis associated with polymyxin B therapy. Front Pharmacol. 2022;13:963140. doi: 10.3389/fphar.2022.963140
  • Wunsch H, Moitra VK, Patel M, et al. Polymyxin use associated with respiratory arrest. Chest. 2012;141(2):515–517. doi: 10.1378/chest.11-1483
  • Dai C, Xiao X, Li J, et al. Molecular mechanisms of neurotoxicity induced by polymyxins and chemoprevention. ACS Chem Neurosci. 2019;10(1):120–131. doi: 10.1021/acschemneuro.8b00300
  • Bayraktar I, Halacli B, Demirkan K, et al. Polymyxin B-related neurotoxicity: a brief case report. Eur J Hosp Pharm. 2023;31(1):66–67. doi: 10.1136/ejhpharm-2023-003786
  • Zhou Y, Li Y, Xie X, et al. Higher incidence of neurotoxicity and skin hyperpigmentation in renal transplant patients treated with polymyxin B. Br J Clin Pharmacol. 2022;88(11):4742–4750. doi: 10.1111/bcp.15384
  • Zou D, Yu H, Li F. The difference between polymyxin B and polymyxin E in causing skin hyerpigmentation. Front Pharmacol. 2021;12:647564. doi: 10.3389/fphar.2021.647564
  • Mattos KP, Lloret GR, Cintra ML, et al. Acquired skin hyperpigmentation following intravenous polymyxin B treatment: a cohort study. Pigment Cell Melanoma Res. 2016;29(3):388–390. doi: 10.1111/pcmr.12468
  • Mattos KPH, Cintra ML, Gouvêa IR, et al. Skin hyperpigmentation following intravenous polymyxin B treatment associated with melanocyte activation and inflammatory process. J Clin Pharm Ther. 2017;42(5):573–578. doi: 10.1111/jcpt.12543
  • Zheng G, Cao L, Che Z, et al. Polymyxin B-induced skin hyperpigmentation: a rare case report and literature review. BMC Pharmacol Toxicol. 2018;19(1):41. doi: 10.1186/s40360-018-0226-1
  • Hauben M, Aronson JK. Defining ‘signal’ and its subtypes in pharmacovigilance based on a systematic review of previous definitions. Drug Saf. 2009;32(2):99–110. doi: 10.2165/00002018-200932020-00003

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.