Clarity and applicability of adverse drug reaction-related monitoring instructions in clinical practice guidelines for children and adolescents treated with antipsychotic drugs: a review of six clinical practice guidelines

Minjon, Lenneke; Aarts, Juul W; Ban, Els van den; Egberts, Toine C. G.; Heerdink, Eibert R.

doi:10.1136/bmjopen-2021-058940

Cited by 2 publications

(5 citation statements)

References 23 publications

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“…We didn't show any association between diagnoses (DSM), disease severity (CGI) or social functioning (CGAS), sex and the presence of psychiatric AEs (p > 0.05); but some studies made other observations [3,15]. Jakobsen and al reported interesting results concerning aripiprazole-associated psychiatric events in children and adolescents through the database of the Danish Medicines Agency.…”

Section: Discussionmentioning

confidence: 70%

“…But hostility/aggression were relatively more frequently reported in children ages 6-11 than in children ages 12-17. In addition, AEs were more frequently reported by health care professionals compared with consumers [15].…”

Section: Discussionmentioning

confidence: 99%

“…In our prospective naturalistic study, the overall psychiatric AEs incidence rate was 1.70 per person-year, and psychiatric AEs were 15.28% of all AE reported. The very few studies to compare our results to come from pharmacovigilance databases [22,15]. Moreover, we cannot compare our incidence rate as pharmacovigilance studies are not appropriate to determine an incidence rate.…”

Section: Discussionmentioning

confidence: 99%

“…In Rafaniello's study, which analyzed spontaneously reported AEs among children and adolescents treated with aripiprazole or risperidone using the EudraVigilance database from 2016 to 2018 [22], the rate of psychiatric AEs was 20.2% (with suicidal behavior reported in 14.9%) on aripiprazole and 15% on risperidone. The Minjon's study, which analyzed AEs reported under AP (mainly risperidone, aripiprazole and quetiapine) in children ages 1-17 years from the global VigiBase database, found a rate of psychiatric AEs of 13.2% [15].…”

Section: Discussionmentioning

confidence: 99%

“…Guidelines are available worldwide (e.g. AACAP in the US, CAMESA in Canada or NICE in the UK) and provide guidance to healthcare professionals on how to monitor the use of AEs with children treated with APs [15]. So for these common AEs, the prescriber is sensitized to the need for regular and repeated monitoring, including clinical and paraclinical parameters throughout exposure to APs [16][17][18].…”

mentioning

confidence: 99%

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Emergence of psychiatric adverse events during antipsychotic treatment in naive children and adolescents

Ménard

Auby

Cruzel³

et al. 2022

Preprint

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Objective: Over the last decades, antipsychotic prescriptions in children have increased worldwide. Nevertheless, adverse events are frequently observed, with some such as psychiatric adverse events remaining poorly documented. Method: The French ETAPE study is a 12-month naturalistic prospective multisite study that included 190 naïve pediatric patients (mean age = 12±3 years), treated by antipsychotic for psychotic or non-psychotic symptoms. From the ETAPE database, we performed additional analyses focusing on psychiatric adverse events.Results: Children received mainly second-generation antipsychotic for conditions out of regulatory approval, with risperidone and aripiprazole being the most frequent (respectively 52.5% and 30.83%). Clinicians reported 2447 adverse events, mainly non-psychiatric (n=2073, 84.72%), including neuromuscular, metabolic, gastroenterological, and (n=374, 15.28%) psychiatric. 55.88% of psychiatric adverse events were attributable to antipsychotic by the clinician, compared to 89% of non-psychiatric AEs (p<0.001). 63.2% (n=120) of the 190 children and adolescents presented at least one psychiatric adverse event. The most frequent were externalized behaviors such as aggressiveness or agitation (22.7%), mood changes (18.4%) and suicidal ideas or behaviors (11.8%). Half of psychiatric adverse events occurred during the first quarter, 49.46%, compared to 23.79% during the second, 15.77% during the third, and 10.96% during the fourth. Conclusion: This additional analysis from the French ETAPE study emphasizes that psychiatric adverse events might be more frequent than expected in the pediatric population. Also, the potential risk of psychiatric adverse events should be part of the benefit-risk evaluation and sub-sequent follow-up.

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Section: Discussionmentioning

confidence: 70%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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Emergence of psychiatric adverse events during antipsychotic treatment in naive children and adolescents

Ménard

Auby

Cruzel³

et al. 2022

Preprint

View full text Add to dashboard Cite

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Emergence of psychiatric adverse events during antipsychotic treatment in AP-naïve children and adolescents

Ménard

Auby²,

Cruzel³

et al. 2022

Child Adolesc Psychiatry Ment Health

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Background Over the last decades, antipsychotic prescriptions in children have increased worldwide. However, adverse events are frequently observed, with some such as psychiatric adverse events remaining poorly documented. Method The French ETAPE study is a 12-month naturalistic prospective multisite study that included 190 antipsychotic-naïve pediatric patients (mean age = 12 ± 3 years), treated by antipsychotic for psychotic or non-psychotic symptoms. From the ETAPE database, we performed additional analyses focusing on psychiatric adverse events. Results Children received mainly second-generation antipsychotic for conditions out of regulatory approval, with risperidone and aripiprazole being the most frequent (respectively 52.5% and 30.83%). Clinicians reported 2447 adverse events, mainly non-psychiatric (n = 2073, 84.72%), including neuromuscular, metabolic, gastroenterological, and (n = 374, 15.28%) psychiatric. 55.88% of psychiatric adverse events were attributable to antipsychotic by the clinician, compared to 89% of non-psychiatric adverse events (p < 0.001). 63.2% (n = 120) of the 190 children and adolescents presented at least one psychiatric adverse event. The most frequent were externalized behaviors such as aggressiveness or agitation (22.7%), mood changes (18.4%) and suicidal ideas or behaviors (11.8%). Half of psychiatric adverse events occurred during the first quarter, 49.46%, compared to 23.79% during the second, 15.77% during the third, and 10.96% during the fourth. Conclusion This additional analysis from the French ETAPE study emphasizes that psychiatric adverse events might be more frequent than expected in the pediatric population. Also, the potential risk of psychiatric adverse events should be part of the benefit-risk evaluation and sub-sequent follow-up.

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Clarity and applicability of adverse drug reaction-related monitoring instructions in clinical practice guidelines for children and adolescents treated with antipsychotic drugs: a review of six clinical practice guidelines

Cited by 2 publications

References 23 publications

Emergence of psychiatric adverse events during antipsychotic treatment in naive children and adolescents

Emergence of psychiatric adverse events during antipsychotic treatment in naive children and adolescents

Emergence of psychiatric adverse events during antipsychotic treatment in AP-naïve children and adolescents

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