Effects of fenfluramine on autistic individuals residing in a state developmental center.

The effects of fenfluramine on 21 maladaptive behaviors in 20 autistic individuals were examined over a 9-month period utilizing a double-blind, cross-over, placebo-controlled design. Raters carried out time-sampled observations in the school and residence. In addition, videotaped data were collected in controlled settings and assessed by the raters at the conclusion of the study. Some individuals displayed negative side effects such as tension, agitation, insomnia, and sweating during the 16-week period they received fenfluramine. The results demonstrated that fenfluramine caused no significant reductions in maladaptive behaviors. The lack of any significant positive results from this medication and the side effects observed strongly indicate the need for caution in the use of fenfluramine with autistic persons.

RCT Entities:   Population Interventions Outcomes