170
Views
0
CrossRef citations to date
0
Altmetric
Review

Respiratory aspiration during treatment with clozapine and other antipsychotics: a literature search and a pharmacovigilance study in vigibase

ORCID Icon, ORCID Icon, ORCID Icon & ORCID Icon
Pages 57-74 | Received 28 Oct 2022, Accepted 14 Mar 2023, Published online: 29 Mar 2023

References

  • Bock JM, Varadarajan V, Brawley MC, et al. Evaluation of the natural history of patients who aspirate. Laryngoscope. 2017;127(Suppl 8):S1–S10.
  • Kikawada M, Iwamoto T, Takasaki M. Aspiration and infection in the elderly: epidemiology, diagnosis and management. Drugs Aging. 2005;22(2):115–130.
  • Son YG, Shin J, Ryu HG. Pneumonitis and pneumonia after aspiration. J Dent Anesth Pain Med. 2017;17(1):1–12.
  • Teramoto S. The current definition, epidemiology, animal models and a novel therapeutic strategy for aspiration pneumonia. Respir Investig. 2022;60(1):45–55.
  • U.S. Food and Drug Administration, ed. Public health advisory: deaths with antipsychotics in elderly patients with behavioral disturbances on April 11, 2005. Cited 2022 Oct 18. Available at https://psychrights.org/drugs/FDAantipsychotics4elderlywarning.htm.
  • U.S. Food and Drug Administration: FDA requests boxed warnings on older class of antipsychotic drugs [news release]. Silver Spring, MD: U.S. Food and Drug Administration; 16 June 2008. The original notice was listed as 2008/ucm116912 but cannot longer found in the FDA page.
  • Papola D, Ostuzzi G, Gastaldon C, et al. Antipsychotic use and risk of life-threatening medical events: umbrella review of observational studies. Acta Psychiatr Scand. 2019;140(3):227–243.
  • Correll CU, Solmi M, Croatto G, et al. Mortality in people with schizophrenia: a systematic review and meta-analysis of relative risk and aggravating or attenuating factors. World Psychiatry. 2022;21(2):248–271.
  • Cicala G, Barbieri MA, Spina E, et al. A comprehensive review of swallowing difficulties and dysphagia associated with antipsychotics in adults. Expert Rev Clin Pharmacol. 2019;12(3):219–234.
  • de Leon J, Sanz EJ, Norén GN, et al. Pneumonia may be more frequent and have more fatal outcomes with clozapine than with other second-generation antipsychotics. World Psychiatry. 2020;19(1):120–121.
  • De Leon J, Sanz EJ, De Las Cuevas C. De Las Cuevas C. Data from the World Health Organization’s pharmacovigilance database supports the prominent role of pneumonia in mortality associated with clozapine adverse drug reactions. Schizophr Bull. 2020;46(1):1–3.
  • Cepaityte D, Siafis S, Egberts T, et al. Exploring a safety signal of antipsychotic-associated pneumonia: a pharmacovigilance-pharmacodynamic study. Schizophr Bull. 2021;47(3):672–681.
  • Schoretsanitis G, Ruan CJ, Rohde C, et al. An update on the complex relationship between clozapine and pneumonia. Expert Rev Clin Pharmacol. 2021;14(2):145–149.
  • Rohde C, Siskind D, de Leon J, et al. Antipsychotic medication exposure, clozapine, and pneumonia: results from a self-controlled study. Acta Psychiatr Scand. 2020;142(2):78–86.
  • Villasante-Tezanos AG, Rohde C, Nielsen J, et al. Pneumonia risk: approximately one-third is due to clozapine and two-thirds is due to treatment-resistant schizophrenia. Acta Psychiatr Scand. 2020;142(1):66–67.
  • Rohde C, Polcwiartek C, Kragholm K, et al. Adverse cardiac events in out-patients initiating clozapine treatment: a nationwide register-based study. Acta Psychiatr Scand. 2018;137(1):47–53.
  • Leung JG, McGrane IR. Improving the clozapine prescribing information to enhance clozapine safety and address barriers: clozapine-induced inflammation, pneumonia, and REMS. Psychiatr Danub. 2022;34(3):422–427.
  • Kaplan J, Schwartz AC, Ward MC. Clozapine-associated aspiration pneumonia: case series and review of the literature. Psychosomatics. 2018;59(2):199–203.
  • Gurrera RJ, Parlee AC, Perry NL. Aspiration pneumonia: an underappreciated risk of clozapine treatment. J Clin Psychopharmacol. 2016;36(2):174–176.
  • Kikuchi Y, Komatsu H, Sakuma A, et al. Successful rechallenge with clozapine after discontinuation due to drug‐induced pneumonia: a case report. PCN Rep. 2022;1:e38
  • Verdoux H, Quiles C, de Leon J. Clinical determinants of fever in clozapine users and implications for treatment management: a narrative review. Schizophr Res. 2019;211:1–9.
  • de Leon J. Reflections on the complex history of the concept of clozapine-induced inflammation during titration. Psychiatr Danub. 2022;34(3):411–421.
  • Shader RI. Some thoughts on pharmacovigilance and postmarketing surveillance. Clin Ther. 2016;38(12):2509–2510.
  • Montastruc JL, Benevent J, Montastruc F, et al. What is pharmacoepidemiology? Definition, methods, interest and clinical applications. Therapie. 2019;74(2):169–174.
  • De Las Cuevas C, Sanz EJ, Ruan CJ, et al. Clozapine-associated myocarditis in the World Health Organization’s pharmacovigilance database: focus on reports from various countries. Rev Psiquiatr Salud Ment (Engl Ed). 2022;15(4):238–250.
  • De Las Cuevas C, Sanz EJ, de Leon J. Respiratory aspiration during treatment with benzodiazepines, antiepileptic and antidepressant drugs in the pharmacovigilance database from VigiBase. Expert Opin Drug Metab Toxicol. 2022;18(9):541–553.
  • Wirth R, Dziewas R, Beck AM, et al. Oropharyngeal dysphagia in older persons - from pathophysiology to adequate intervention: a review and summary of an international expert meeting. Clin Interv Aging. 2016;11:189–208.
  • Takizawa C, Gemmell E, Kenworthy J, et al. A systematic review of the prevalence of oropharyngeal dysphagia in stroke, Parkinson’s disease, Alzheimer’s disease, head injury, and pneumonia. Dysphagia. 2016;31(3):434–441.
  • Espinosa-Val MC, Martín-Martínez A, Graupera M, et al. Prevalence, risk factors, and complications of oropharyngeal dysphagia in older patients with dementia. Nutrients. 2020;12(3):863.
  • Robertson J, Chadwick D, Baines S, et al. Prevalence of dysphagia in people with intellectual disability: a systematic review. Intellect Dev Disabil. 2017;55(6):377–391.
  • Sheppard JJ, Hochman R, Baer C. The dysphagia disorder survey: validation of an assessment for swallowing and feeding function in developmental disability. Res Dev Disabil. 2014;35(5):929–942.
  • Sheppard JJ, Malandraki GA, Pifer P, et al. Validation of the choking risk assessment and pneumonia risk assessment for adults with intellectual and developmental disability (IDD). Res Dev Disabil. 2017;69:61–76.
  • DeToledo JC, Lowe MR, Gonzalez J, et al. Risk of aspiration pneumonia after an epileptic seizure: a retrospective analysis of 1634 adult patients. Epilepsy Behav. 2004;5(4):593–595.
  • O’Neill JL, Remington TL. Drug-induced esophageal injuries and dysphagia. Ann Pharmacother. 2003;37(11):1675–1684.
  • Kaindlstorfer A, Pointner R. An appraisal of current dysphagia diagnosis and treatment strategies. Exp Rev Gastroenterol Hepatol. 2016;10(8):929–942.
  • Osterman MT, Foley C, Matthias I. Clozapine-induced acute gastrointestinal necrosis: a case report. J Med Case Rep. 2017;11(1):270.
  • Flanagan RJ, Ball RY. Gastrointestinal hypomotility: an under-recognised life-threatening adverse effect of clozapine. Forensic Sci Int. 2011;206(1–3):e31–e36.
  • Leung JS, Lee CC, Lee WK, et al. Rapidly fatal clozapine-induced intestinal obstruction without prior warning signs. Aust N Z J Psychiatry. 2008;42(12):1073–1074.
  • De Weerdt A, Snoeckx A, Germonpré P, et al. Rapid-onset adult respiratory distress syndrome after activated charcoal aspiration. A pitch-black tale of a potential to kill. Am J Respir Crit Care Med. 2015;191(3):344–345.
  • Norén GN, Hopstadius J, Bate A. Shrinkage observed-to-expected ratios for robust and transparent large-scale pattern discovery. Stat Methods Med Res. 2013;22(1):57–69.
  • Palmer SE, McLean RM, Ellis PM, et al. Life-threatening clozapine-induced gastrointestinal hypomotility: an analysis of 102 cases. J Clin Psychiatry. 2008;69(5):759–768.
  • de Leon J. According to the WHO clozapine pharmacovigilance database, the United Kingdom accounts for 968 fatal outcomes versus 892 in the rest of the world. Br J Clin Pharmacol. 2022;88(12):5434–5435.
  • Cumming G. The new statistics: why and how. Psychol Sci. 2014;25(1):7–29.
  • De Las Cuevas C, Sanz EJ, Rohde C, et al. Association between myocarditis and antipsychotics other than clozapine: a systematic literature review and a pharmacovigilance study using VigiBase. Expert Rev Clin Pharmacol. 2022;15(1):65–78.
  • Leung JG, de Leon J, Frye MA, et al. The modernization of clozapine: a recapitulation of the past in the United States and the view forward. J Clin Psychopharmacol. 2022;42(6):565–580.
  • Tang YL, Mao PX, Jiang F, et al. Clozapine in China. Pharmacopsychiatry. 2008;41(1):1–9.
  • Li XB, Tang YL, Wang CY, et al. Clozapine for treatment-resistant bipolar disorder: a systematic review. Bipolar Disord. 2015;17(3):235–247.
  • Xu SW, Dong M, Zhang Q, et al. Clozapine prescription pattern in patients with schizophrenia in Asia: the REAP survey (2016). Psychiatry Res. 2020;287:112271.
  • Kostev K, Osina G, Konrad M. Treatment patterns of patients with schizophrenia based on the data from 44,836 outpatients in Russia. Heart Mind. 2019;3:161–164
  • Slyundin DG, Livanov AS, Anuchin VV, et al. Specific features of psychopathological manifestations in criminal clozapine intoxications. Nevrol nejropsihiatr psihosom. 2010;2:57–63. [ Article in Russian
  • Kirilochev OO, De Las Cuevas C, de Leon J. Clozapine-induced myocarditis in Russia: animal studies but no clinical studies. Rev Psiquiatr Salud Ment (Engl Ed). 2022;15(4)294–295.
  • Kirilochev OO, Dorfman IP, Umerova AR. Monitoring drug safety in Astrakhan, Russia. Int J Risk Saf Med. 2015;27(Suppl 1):S33–S34.
  • Duckett SA, Bartman M, Roten RA. Choking. 2022 Apr 30. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan. PMID: 29763116.
  • Simpson E. How to manage a choking adult. Nurs Stand. 2016;31(3):42–46.
  • Hemsley B, Steel J, Sheppard JJ, et al. Dying for a meal: an integrative review of characteristics of choking incidents and recommendations to prevent fatal and nonfatal choking across populations. Am J Speech Lang Pathol. 2019;28(3):1283–1297.
  • Bishara D, Taylor D. Adverse effects of clozapine in older patients: epidemiology, prevention and management. Drugs Aging. 2014;31(1):11–20.
  • Teodorescu A, Dima L, Ifteni P, et al. Clozapine for treatment-refractory behavioral disturbance in dementia. Am J Ther. 2018;25(3):e320–e325.
  • de Leon J, Ruan CJ, Schoretsanitis G, et al. Dose and safety concerns of clozapine: worldwide package inserts need revisions. Schizophr Res. 2020;216:2–4.
  • de Leon J, De Las Cuevas C, Sanz EJ, et al. Clozapine and the risk of haematological malignancies. Lancet Psychiatry. 2022;9(7):537–538.
  • Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30(2):239–245.
  • Streiner DL. Statistics commentary series: commentary #14–confidence intervals. J Clin Psychopharmacol. 2016;36(3):198–199.
  • Taipale H, Lähteenvuo M, Tanskanen A, et al. Comparative effectiveness of antipsychotics for risk of attempted or completed suicide among persons with schizophrenia. Schizophr Bull. 2021;47(1):23–30.
  • Forte A, Pompili M, Imbastaro B, et al. Effects on suicidal risk: comparison of clozapine to other newer medicines indicated to treat schizophrenia or bipolar disorder. J Psychopharmacol. 2021;35(9):1074–1080.
  • Tan MSA, Honarparvar F, Falconer JR, et al. A systematic review and meta-analysis of the association between clozapine and norclozapine serum levels and peripheral adverse drug reactions. Psychopharmacology (Berl). 2021;238(3):615–637.
  • Schoretsanitis G, Kane JM, Ruan CJ, et al. A comprehensive review of the clinical utility of and a combined analysis of the clozapine/norclozapine ratio in therapeutic drug monitoring for adult patients. Expert Rev Clin Pharmacol. 2019;12(7):603–621.
  • de Leon J, Simpson GM. Postmortem clozapine levels. J Clin Psychopharmacol. 2004;24(1):100–101.
  • St ark A, Scott J. A review of the use of clozapine levels to guide treatment and determine cause of death. Aust N Z J Psychiatry. 2012;46(9):816–825.
  • de Leon J. The history of clozapine in clinical practice: from its introduction to a guideline proposing personalized titrations. J Psychopharmacol. 2022;36(6):657–660.
  • de Leon J, Schoretsanitis G, Smith RL, et al. An international adult guideline for making clozapine titration safer by using six ancestry-based personalized dosing titrations, CRP, and clozapine levels. Pharmacopsychiatry. 2022;55(2):73–86.
  • de Leon J, Ruan CJ, Schoretsanitis G, et al. An international guideline with six personalised titration schedules for preventing myocarditis and pneumonia associated with clozapine. Gen Psychiatr. 2022;35(3):e100773.

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.