(198) Reports of Adverse Events Related with Second Generation Antipsychotics in Children in The FDA Adverse Event Reporting System (FAERS)

Publication Number: 1243

Background: Although second-generation antipsychotics (SGAs) are increasingly used in children and adolescents, most data on their safety are obtained from studies involving adults. Information about the occurrence of SGA-related adverse events (AEs) in pediatric populations is therefore limited.

Objectives: The objective of this study is to provide an overview of SGA-related AEs in children and adolescents using reports submitted to the FDA’s Adverse Event Reporting System (FAERS) database.

Methods: Case reports involving children between 5 to 17 years old using asenapine, lurasidone and paliperidone were identified using the FAERS database . Only reports from the U.S. were considered, and duplicate observations were removed. Principal variables analyzed included: event date, gender, outcomes, AE reported, reason for use and reporter source

Results: The FAERS search identified a total of 676 SGA-related AEs, of which 321 were in females. 61 were related with asenapine, of which 51% of which were in females. Half of the reported SGA indications for asenapine were off-label (e.g., depression, anxiety, attention deficit disorder). The most frequently reported AEs were suicidal thought ideation (10%), hypersensitivity (7%), somnolence (5%), dizziness (3%), and oral hypoesthesia (3%) 57% were classified as non-serious and resolved without hospitalization. A total of 321 case reports involving lurasidone were identified, of which 34% were in females. Fewer than 30% of these reports included off-label indications. AEs included weight gain (7%) suicidal ideation (6%), somnolence (5%), akathisia (3%), and anxiety (3%), and 66% of cases were classified as a non-serious; however, there were two reports of fatal outcomes. A total of 382 case reports involving paliperidone were identified, of which 69% were in females. Approximately 79% of these cases included off-label indications. Frequent AEs reported included dystonia (8%), weight gain (7%), galactorrhea (6%), dyskinesia (5%), and extrapyramidal disease (4%), and (17%) of cases required hospitalization. Considering all 3 SGAs, more than 70% of reports were originated by a healthcare provider.

Conclusions: This study focuses on reported AEs in young patients receiving SGAs. Reports frequently involved off-label SGA utilization. A considerable number of patients required hospitalization and a significant occurrence of suicidal ideation was reported. It is necessary to closely monitor off-label utilization of these agents in pediatric populations.