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Neuroleptic malignant syndrome associated with second-generation antipsychotics (SGA): An analysis of reported cases in eudravigilance database, 2017-2020

Published online by Cambridge University Press:  13 August 2021

A. Torres ,
A. Mignano ,
I. Viseu ,
L. Rodrigues ,
T. Herdeiro ,
L. Silva  and
V. Afreixo
A. Torres*
Affiliation:
Nursing, Portuguese Red Cross Northern Health School, Oliveira de Azeméis, Portugal Department Of Education And Psychology Of University Of Aveiro, CINTESIS - UA – Center for Health Technology and Services Research, Portugal (R&D Unit ref. UIDB/4255/2020), Aveiro, Portugal Department Of Mathematics, University of Aveiro, Aveiro, Portugal
A. Mignano
Affiliation:
Department Of Mathematics, University of Aveiro, Aveiro, Portugal Department Of Biology, University of Federico II, Napoli, Italy
I. Viseu
Affiliation:
Department Of Mathematics, University of Aveiro, Aveiro, Portugal
L. Rodrigues
Affiliation:
Department Of Mathematics, University of Aveiro, Aveiro, Portugal
T. Herdeiro
Affiliation:
Department Of Medical Sciences, University of Aveiro, Aveiro, Portugal
L. Silva
Affiliation:
Department Of Mathematics, University of Aveiro, Aveiro, Portugal
V. Afreixo
Affiliation:
Department Of Mathematics, University of Aveiro, Aveiro, Portugal
*
*Corresponding author.

Abstract

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Introduction

Antipsychotic drugs are the cornerstone of the pharmacological treatment of psychotic disorders; however, even with Second-generation antipsychotics (SGA), adverse effects continue to be extremely accentuated and the treatment effectiveness is compromised by low adherence of the patient.

Objectives

Taking into consideration the importance of adverse effects for psychotic therapeutics, this study aims to analyze the adverse effect of the Neuroleptic Malignant Syndrome (NMS) reported in EudraVigilance Database, associated with 3 widely used SGA, Risperidone, Quetiapine, and Clozapine.

Methods

The EudraVigilance Database was analyzed from 09/01/2017 to 31/10/2020 about NMS, associated with Risperidone, Quetiapine, and Clozapine. NMS is the second most reported adverse effect inside the Nervous System Disorders SOC (System Organ Class). There were just considered NMS as suspected adverse effect.

Results

It was observed a general tendency of reduction of NMS reports from 2017 to 2020 (most of them performed by healthcare professionals). Risperidone presented the highest level of reports during this period (more than 350), followed by Quetiapine and Clozapine. The NMS reports were predominantly referred to the male sex, from 18 to 64 years old. Risperidone presented the lowest number of fatal cases of NMS (1), in contrast with 3 reported with Quetiapine and Clozapine. A significant number of patients with Schizophrenia recovered from NMS.

Conclusions

It is important to do clinical monitoring of the NMS, because it is rare, although it has life-threatening consequences. Pharmacovigilance databases are important tools to evaluate the safety of drugs and it must be more widely and efficiently promoted for healthcare and patients use.

Disclosure

No significant relationships.

Keywords

second-generation antipsychotics (SGA)EudraVigilanceneuroleptic malignant syndromePsychotic disorders
Type
Abstract
Information
European Psychiatry , Volume 64 , Special Issue S1: Abstracts of the 29th European Congress of Psychiatry , April 2021 , pp. S814
Creative Commons
Creative Common License - CCCreative Common License - BY
This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
Copyright
© The Author(s), 2021. Published by Cambridge University Press on behalf of the European Psychiatric Association
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