The results of the multisite randomized clinical trial of fluoxetine in children and adolescents with autism spectrum disorder (ASD) reported by Reddihough and colleagues in this issue of JAMA1 will challenge the field to reconcile the limited performance of the drug with long-standing utilization patterns. Fluoxetine and other selective serotonin reuptake inhibitors (SSRIs) have been among the most widely prescribed medications for individuals with ASD for well over a decade. In 2008, when this trial was first registered with the Australian and New Zealand Clinical Trials Registry,2 there were few data to guide the field, and these drugs accounted for almost a third of all psychotropic prescriptions in this patient population. Over subsequent years, frequent use of these medications continued despite a Cochrane review,3 highlighted in recent practice guidelines for ASD,4 that concluded there was no evidence of effect of SSRIs in children, limited evidence in adults, and even emerging evidence of harm.
King BH. Fluoxetine and Repetitive Behaviors in Children and Adolescents With Autism Spectrum Disorder. JAMA. 2019;322(16):1557–1558. doi:10.1001/jama.2019.11738
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