Reported Adverse Drug Reactions in Children and Adolescents Treated with Antipsychotics

Minjon, Lenneke; Ban, Els van den; Jong, Emma de; Souverein, Patrick C.; Egberts, Toine C. G.; Heerdink, Eibert R.

doi:10.1089/cap.2018.0139

Cited by 30 publications

(29 citation statements)

References 28 publications

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“…This study aims to provide a comprehensive overview of all ICSRs spontaneously reported to EV (one of the largest pharmacovigilance databases) in the pediatric population with a huge variety of psychiatric disorders treated with risperidone and aripiprazole, contributing to define their safety profiles in real-world settings. In line with recent pharmacoepidemiological studies evaluating the safety profile of SGAs in the young population, we found that the largest proportion of ICSRs was reported for boys, and the most frequently reported suspected antipsychotic drug was risperidone (19,20). These findings are consistent with previous evidence showing that male adolescents are more likely than females to be prescribed atypical antipsychotics and that risperidone is the SGA most commonly prescribed to the young population due to a wider spectrum of indicated uses (21).…”

Section: Discussionsupporting

confidence: 91%

We Really Need Clear Guidelines and Recommendations for Safer and Proper Use of Aripiprazole and Risperidone in a Pediatric Population: Real-World Analysis of EudraVigilance Database

et al. 2020

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Background: Although aripiprazole and risperidone are used widespread in pediatrics, there are still limited pieces of evidence on their actual safety profile. By using the EudraVigilance database, we carried out an analysis to perform a comprehensive overview of reported adverse events among children and adolescents treated with aripiprazole and risperidone.Methods: Descriptive analysis was performed of all individual case safety reports (ISCRs) submitted to EudraVigilance associated with aripiprazole and risperidone and related to the pediatric population from 2016 to 2018.Results: A total of 855 and 2,242 ISCRs for aripiprazole and risperidone, respectively, were recorded for a total of 11,042 suspected adverse drug reactions (2,993 for aripiprazole and 8,049 for risperidone). Most ISCRs were related to male patients (65.0 and 86.3% for aripiprazole and risperidone, respectively) and were serious (81.0 and 94.1% for aripiprazole and risperidone, respectively). Schizophrenia spectrum and other psychotic disorders, such as disruptive, impulse-control, and conduct disorders, and autism spectrum disorder were the top three clinical indications for aripiprazole (19.0, 16.1, and 11.6%, respectively). For risperidone, attention-deficit/hyperactivity disorder (25.4%), disruptive, impulse-control, and conduct disorders (17.1%), and bipolar and related disorders (14.2%) were more commonly reported as clinical indications. Data also showed a high proportion of use for clinical conditions not authorized in children. Psychiatric disorders were the main related adverse events for aripiprazole (20.2%), and among these, suicidal behavior was one of the most reported (14.9%). Reproductive system and breast disorders were the main related adverse events for risperidone (19.8%), and gynecomastia was the most reported event; metabolism and nutrition disorders, mainly reported as weight gain disorders, were more reported in children (3–11 years) than in adolescents (12–17 years).Conclusions: Our results demonstrate that spontaneously reported adverse events associated with aripiprazole and risperidone reflect what is already known in terms of safety profile, although with about 90% of them being serious. This analysis stresses the need for further studies and effective training and information activities to better define the actual benefit/risk ratio of these drugs in pediatric patients.

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Section: Discussionsupporting

confidence: 91%

We Really Need Clear Guidelines and Recommendations for Safer and Proper Use of Aripiprazole and Risperidone in a Pediatric Population: Real-World Analysis of EudraVigilance Database

et al. 2020

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“…commented that, with the exception of drug companies, SRS are limited by their passivity because they are voluntary. 16 , 18 Montastruc et al ., 2015 suggested that notoriety bias (from safety alerts) accounted for the high numbers of reports with olanzapine and clozapine. 15 Minjon et al .…”

Section: Discussionmentioning

confidence: 99%

“… 15 Another recent observational cohort study by Ray et al ., showed that increased unexpected death was observed in children and youth using antipsychotics. 16 However, the results of this study were from hospitalised patients and lacked any information about the general population.…”

Section: Introductionmentioning

confidence: 99%

Characteristics of voluntary reporting of adverse drug events related to antipsychotics in Australia: 14-year analysis

Khalil

Hoppe

Ameen

2021

Therapeutic Advances in Drug Safety

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Background: Retrospective analyses of large databases of treated patients can provide useful links to the presence of drug misuse or rare and infrequent adverse effects, such as agranulocytosis, diabetic ketoacidosis or neuroleptic malignant syndrome. The aim of this study is to describe the adverse effects to antipsychotics reported in the Australian Database of Adverse Event Notifications (DAEN). Methods: Data were collected from the DAEN – a spontaneous reporting database. The database, which covered the period from January 2004 to December 2017, was obtained from the Therapeutic Goods Administration (TGA) website ( www.TGA.gov ). The drugs selected for this investigation are the following: aripiprazole, clozapine, olanzapine, paliperidone, risperidone, ziprasidone, quetiapine, haloperidol and pimozide. All data were analysed descriptively. Comparison of reporting and management of adverse events between adults (older than 20 years) and children (5–19 years) was undertaken using chi squared test, where p < 0.05 is significant. Results: A total of 7122 adverse events associated with the antipsychotics aripiprazole, clozapine, haloperidol, olanzapine, paliperidone, pimozide, quetiapine and risperidone were reported to the TGA between January 2004 and December 2017. On average, there were 2.6 adverse events reported for each case. The most common adverse event reported for antipsychotics was neuroleptic malignant syndrome. There were no significant differences in the number of co-medications, formulations, indications, therapeutic dose, hospital admission and overdose among the antipsychotics between paediatric and adult populations. However, there were significant differences between causality, death and the management of adverse events between adult and paediatric populations (5–19 years) ( p < 0.05, chi squared test). Conclusion: The antipsychotic drug associated with the highest adverse events in adults was clozapine, followed by olanzapine. The most common adverse event in adults, and reported with a number of antipsychotic drugs, was neuroleptic malignant syndrome. In children, the highest numbers of adverse events reported in the database were associated with risperidone, clozapine and olanzapine. Plain language summary Adverse events reported of antipsychotics Background: Retrospective analyses of large databases of treated patients can provide useful clues to the presence of drug misuse or rare and infrequent adverse effects associated with antipsychotics. The drugs selected for this investigation are the following: aripiprazole, clozapine, olanzapine, paliperidone, risperidone, ziprasidone, quetiapine, haloperidol and pimozide. Methods: All data were analysed descriptively and investigated for any associations between the variables collected. Comparison of reporting and management of adverse events between adults (older than 20 years) and children (5–19 years) was undertaken using chi squared test, where p < 0.05 is significant. Results: The antipsychotic drug associated with the highest adverse events was clozapine, followed by olanzapine. In children, the highest numbers of adverse events reported in the database were associated with risperidone, clozapine and olanzapine. The most common adverse event in adults, and reported with a number of antipsychotic drugs, was neuroleptic malignant syndrome. Conclusion: There were significant differences between causality, death and the management of adverse events between adult and paediatric populations (5–19 years).Keywords: Antipsychotics, adverse effects, adverse events, safety

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“…Furthermore, it is well-documented that antipsychotic drugs frequently cause bothersome and even severe adverse drug reactions (ADRs), including cardiometabolic, endocrine, and extrapyramidal adverse effects (4,5). Examples of these adverse effects include weight gain, hypertension, gynecomastia, and parkinsonism (4)(5)(6). These ADRs can differ in frequency and relative impact in children compared to adults (7).…”

Section: Introductionmentioning

confidence: 99%

Monitoring of Adverse Drug Reaction-Related Parameters in Children and Adolescents Treated With Antipsychotic Drugs in Psychiatric Outpatient Clinics

et al. 2021

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Aim: To assess the frequency of monitoring of adverse drug reaction (ADR) related parameters in children and adolescents treated with antipsychotic drugs in psychiatric outpatient clinics and the considerations when monitoring was not performed.Methods: This retrospective follow-up study included 100 randomly selected outpatients aged ≤18 years who had a first prescription of an antipsychotic drug recorded in the electronic medical records of psychiatric outpatient clinics between 2014 and 2017. They were followed for up to 3 years. This study assessed the frequency of monitoring for physical parameters (weight, height, body mass index, waist circumference, pulse, blood pressure, and an electrocardiogram) and laboratory parameters (glucose, lipids, and prolactin) before the first prescription of an antipsychotic drug as well as during its use. Monitoring frequencies were stratified by the patient characteristics (sex, age, cardiovascular risk factors, and use of other psychotropic drugs), and by location of antipsychotic drug initiation (psychiatric outpatient clinic or elsewhere). Additionally, this study assessed the considerations mentioned in the medical records for not monitoring ADR-related parameters.Results: Overall, physical parameters were monitored more frequently (weight: 85.9% during the first half-year) than laboratory parameters (glucose and cholesterol: both 23.5%). There were no significant differences in monitoring at least one physical as well as in monitoring at least one laboratory parameter during the baseline period and during the total follow-up of antipsychotic drug treatment between the patient characteristics. In total, 3% of the children and adolescents were never monitored for any physical parameter, and 54% were never monitored for any laboratory parameter. For a minority of the children (14.8%) who were never monitored for laboratory parameters, considerations were recorded in their medical records, including refusal by the child or parents and monitoring performed by the general practitioner or elsewhere.Conclusion: Monitoring frequencies of ADR-related parameters in children and adolescents treated with antipsychotic drugs in psychiatric outpatient clinics varied and especially monitoring of laboratory parameters was infrequent. Considerations why monitoring was not performed were rarely recorded. The optimal method of monitoring and documentation thereof should become clear to optimize the benefit-risk balance of antipsychotic drug treatment for each child.

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Reported Adverse Drug Reactions in Children and Adolescents Treated with Antipsychotics

Cited by 30 publications

References 28 publications

We Really Need Clear Guidelines and Recommendations for Safer and Proper Use of Aripiprazole and Risperidone in a Pediatric Population: Real-World Analysis of EudraVigilance Database

We Really Need Clear Guidelines and Recommendations for Safer and Proper Use of Aripiprazole and Risperidone in a Pediatric Population: Real-World Analysis of EudraVigilance Database

Characteristics of voluntary reporting of adverse drug events related to antipsychotics in Australia: 14-year analysis

Monitoring of Adverse Drug Reaction-Related Parameters in Children and Adolescents Treated With Antipsychotic Drugs in Psychiatric Outpatient Clinics

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