Incidence of adverse events in antipsychotic-naïve children and adolescents treated with antipsychotic drugs: Results of a multicenter naturalistic study (ETAPE)

Ménard, Marie-Line; Thümmler, Susanne; Giannitelli, Marianna; Cruzel, Coralie; Bonnot, Olivier; Cohen, David; Askénazy, Florence; Boublil, Michel; Chambry, Jean; Charvet, Dorothée; Cseterky, Mona; Fontas, Éric; Fourneret, Pierre; Gicquel, Ludovic; Kabuth, Bernard; Leroy, B.; Maria, F.; Moceri, P.; Parassol‐Girard, Nadège; Ravis, B.; Raynaud, J.-P.; Roche, Jane; Rochet, Thierry

doi:10.1016/j.euroneuro.2019.10.006

Cited by 15 publications

(16 citation statements)

References 36 publications

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“…Within the class of SGAs, risperidone, and aripiprazole are the most frequently prescribed in children and adolescents across most countries (2). They are approved medications for bipolar mania in children and adolescents, for adolescent schizophrenia, and for behavioral disturbances (irritability and aggression) associated with autism and/or intellectual disabilities in children and adolescents (3). Risperidone and aripiprazole are frequently prescribed in these populations also as treatment of attention-deficit/hyperactivity disorder (ADHD), eating disorders, anxiety, and sleep disorders (4,5).…”

Section: Introductionmentioning

confidence: 99%

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: Introductionmentioning

confidence: 99%

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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“…Despite this, most antipsychotic prescription in youth is off-label. In the United States, it is estimated that around 66–80% of SGAs are prescribed off-label to youth with common diagnoses being Attention-Deficit/Hyperactivity Disorder (ADHD) and depression [ 13 , 14 ]. Among developed countries, the United States has the highest rates of antipsychotic prescription in youth [ 15 ].…”

Section: Epidemiology Of Antipsychotic-related Metabolic Syndromementioning

confidence: 99%

“…SGA prescription in youth carries a higher risk of side effects than in the adult population in general, including weight gain [ 7 ]. Youth prescribed SGAs are also much less likely than their adult counterparts to undergo recommended monitoring of metabolic parameters [ 14 ].…”

Section: Epidemiology Of Antipsychotic-related Metabolic Syndromementioning

confidence: 99%

“…Of the various longitudinal studies involving youth taking SGAs, weight gain occurs commonly. In a European trial, 53.4% of youth prescribed an SGA experienced a metabolic side effect, most commonly within the first three months of starting the medication [ 14 ]. The average weight gain over a twelve-month period was around 5 kg, with body mass index (BMI) increasing by 1.5 points [ 14 ].…”

Section: Epidemiology Of Antipsychotic-related Metabolic Syndromementioning

confidence: 99%

“…In a European trial, 53.4% of youth prescribed an SGA experienced a metabolic side effect, most commonly within the first three months of starting the medication [ 14 ]. The average weight gain over a twelve-month period was around 5 kg, with body mass index (BMI) increasing by 1.5 points [ 14 ]. Clinically significant elevations in cholesterol occurred in about 36%, and diabetes developed in about 7% in this study.…”

Section: Epidemiology Of Antipsychotic-related Metabolic Syndromementioning

confidence: 99%

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Integrative Management of Metabolic Syndrome in Youth Prescribed Second-Generation Antipsychotics

Rice

Ramtekkar

2020

Medical Sciences

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Weight gain and metabolic syndrome are common side effects of second-generation antipsychotics and carry significant health consequences both in childhood and into adulthood. This review highlights evidence-based, non-pharmacologic interventions to assist in the management of these side effects. Such intervention categories include dietary, physical activity, sleep, stress management, and nutritional supplementation. Interventions with the highest quality evidence include increasing the consumption of fruits, vegetables, and whole grains, increasing physical activity, improving sleep, and fish oil supplementation. We suggest that clinicians work with patients on managing metabolic side effects in a patient-centered way, incorporating principles of motivational interviewing, to reduce the risk of metabolic syndrome.

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Drug-Induced Movement Disorders in Children

Singer¹,

Mink²,

Gilbert³

et al. 2022

Movement Disorders in Childhood

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Incidence of adverse events in antipsychotic-naïve children and adolescents treated with antipsychotic drugs: Results of a multicenter naturalistic study (ETAPE)

Cited by 15 publications

References 36 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

Integrative Management of Metabolic Syndrome in Youth Prescribed Second-Generation Antipsychotics

Drug-Induced Movement Disorders in Children

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