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De Berardis D, Rapini G, Olivieri L, et al. Safety of antipsychotics for the treatment of schizophrenia: a focus on the adverse effects of clozapine. Ther Adv Drug Saf. 2018;9(5):237-256doi: 10.1177/2042098618756261.
De Berardis, D., Rapini, G., Olivieri, L., Di Nicola, D., Tomasetti, C., Valchera, A., Fornaro, M., Di Fabio, F., Perna, G., Di Nicola, M., Serafini, G., Carano, A., Pompili, M., Vellante, F., Orsolini, L., Martinotti, G., & Di Giannantonio, M. (2018). Safety of antipsychotics for the treatment of schizophrenia: a focus on the adverse effects of clozapine. Therapeutic advances in drug safety, 9(5), 237-256. https://doi.org/10.1177/2042098618756261
De Berardis, Domenico, et al. "Safety of antipsychotics for the treatment of schizophrenia: a focus on the adverse effects of clozapine." Therapeutic advances in drug safety vol. 9,5 (2018): 237-256. doi: https://doi.org/10.1177/2042098618756261
De Berardis D, Rapini G, Olivieri L, Di Nicola D, Tomasetti C, Valchera A, Fornaro M, Di Fabio F, Perna G, Di Nicola M, Serafini G, Carano A, Pompili M, Vellante F, Orsolini L, Martinotti G, Di Giannantonio M. Safety of antipsychotics for the treatment of schizophrenia: a focus on the adverse effects of clozapine. Ther Adv Drug Saf. 2018 May;9(5):237-256. doi: 10.1177/2042098618756261. Epub 2018 Feb 06. PMID: 29796248; PMCID: PMC5956953.
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Ther Adv Drug Saf. 2018 May;9(5):237-256. doi: 10.1177/2042098618756261. Epub 2018 Feb 06.

Safety of antipsychotics for the treatment of schizophrenia: a focus on the adverse effects of clozapine.

Therapeutic advances in drug safety

Domenico De Berardis, Gabriella Rapini, Luigi Olivieri, Domenico Di Nicola, Carmine Tomasetti, Alessandro Valchera, Michele Fornaro, Fabio Di Fabio, Giampaolo Perna, Marco Di Nicola, Gianluca Serafini, Alessandro Carano, Maurizio Pompili, Federica Vellante, Laura Orsolini, Giovanni Martinotti, Massimo Di Giannantonio

Affiliations

  1. National Health Service, Department of Mental Health, Psychiatric Service of Diagnosis and Treatment, 'G. Mazzini' Hospital, p.zza Italia 1, 64100 Teramo, Italy.
  2. National Health Service, Department of Mental Health, Psychiatric Service of Diagnosis and Treatment, 'G. Mazzini' Hospital, Teramo, Italy.
  3. Polyedra Research Group, Teramo, Italy Department of Neuroscience, Reproductive Science and Odontostomatology, School of Medicine 'Federico II' Naples, Naples, Italy.
  4. Polyedra Research Group, Teramo, Italy Villa S. Giuseppe Hospital, Hermanas Hospitalarias, Ascoli Piceno, Italy.
  5. Department of Neuroscience, Reproductive Science and Odontostomatology, School of Medicine 'Federico II' Naples, Naples, Italy.
  6. Polyedra Research Group, Teramo, Italy Department of Neurology and Psychiatry, Sapienza University of Rome, Rome, Italy.
  7. Hermanas Hospitalarias, FoRiPsi, Department of Clinical Neurosciences, Villa San Benedetto Menni, Albese con Cassano, Como, Italy Department of Psychiatry and Neuropsychology, University of Maastricht, Maastricht, The Netherlands Department of Psychiatry and Behavioral Sciences, Leonard Miller School of Medicine, University of Miami, Florida, USA.
  8. Institute of Psychiatry and Psychology, Catholic University of Sacred Heart, Rome, Italy.
  9. Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, Section of Psychiatry, University of Genoa, Genoa, Italy.
  10. National Health Service, Department of Mental Health, Psychiatric Service of Diagnosis and Treatment, Hospital 'Madonna Del Soccorso', San Benedetto del Tronto, Italy.
  11. Department of Neurosciences, Mental Health and Sensory Organs, Suicide Prevention Center, Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy.
  12. Department of Neuroscience, Imaging and Clinical Science, Chair of Psychiatry, University 'G. D'Annunzio', Chieti, Italy.
  13. Polyedra Research Group, Teramo, Italy Psychopharmacology, Drug Misuse and Novel Psychoactive Substances Research Unit, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, Herts, UK.

PMID: 29796248 PMCID: PMC5956953 DOI: 10.1177/2042098618756261

Abstract

Clozapine, a dibenzodiazepine developed in 1961, is a multireceptorial atypical antipsychotic approved for the treatment of resistant schizophrenia. Since its introduction, it has remained the drug of choice in treatment-resistant schizophrenia, despite a wide range of adverse effects, as it is a very effective drug in everyday clinical practice. However, clozapine is not considered as a top-of-the-line treatment because it may often be difficult for some patients to tolerate as some adverse effects can be particularly bothersome (i.e. sedation, weight gain, sialorrhea etc.) and it has some other potentially dangerous and life-threatening side effects (i.e. myocarditis, seizures, agranulocytosis or granulocytopenia, gastrointestinal hypomotility etc.). As poor treatment adherence in patients with resistant schizophrenia may increase the risk of a psychotic relapse, which may further lead to impaired social and cognitive functioning, psychiatric hospitalizations and increased treatment costs, clozapine adverse effects are a common reason for discontinuing this medication. Therefore, every effort should be made to monitor and minimize these adverse effects in order to improve their early detection and management. The aim of this paper is to briefly summarize and provide an update on major clozapine adverse effects, especially focusing on those that are severe and potentially life threatening, even if most of the latter are relatively uncommon.

Keywords: adverse effects; clozapine; life threatening; management; resistant schizophrenia

Conflict of interest statement

Conflict of interest statement: No author or immediate family member has financial relationships with commercial organizations that might appear to represent a potential conflict of interest with the

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