Untoward effects of fenfluramine in autistic children. 1986

G M Realmuto, and J Jensen, and W Klykylo, and L Piggott, and G Stubbs, and A Yuwiler, and E Geller, and B J Freeman, and E Ritvo

Several recent studies have described the benefits of fenfluramine for the symptomatic treatment of infantile autism. No large surveys of side effects of this drug have been reported in autistic children. To evaluate the untoward effects of fenfluramine in children with autism, 12 subjects were systematically studied. Medication was administered in a double-blind, placebo-controlled cross-over study. Parents were trained in monitoring untoward effects. These observations were compiled in detailed daily notes. In addition, four cases describing unusual effects found in a sample of 170 patients treated with fenfluramine are also reported. In the initial 2 weeks of active drug listlessness, food refusal, and stomach upset were frequently seen. A different pattern of untoward effects was seen in the final 14 weeks of treatment. Irritability, agitation, and crying along with continued food refusal were noted. The subjects lost 2.1% of body weight during active drug phase, but there was a rebound weight gain during the subsequent placebo phase. A thorough understanding of fenfluramine's side effects and adverse reactions is necessary so as to differentiate them from the multiple symptoms inherent in the syndrome of autism.

UI MeSH Term Description Entries
D008297 Male Males
D002648 Child A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL. Children
D002675 Child, Preschool A child between the ages of 2 and 5. Children, Preschool,Preschool Child,Preschool Children
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260 Female Females
D005277 Fenfluramine A centrally active drug that apparently both blocks serotonin uptake and provokes transport-mediated serotonin release. Fintepla,Fenfluramine Hydrochloride,Fenfluramine Hydrochloride, (+-)-Isomer,Fenfluramine Hydrochloride, R-Isomer,Fenfluramine, (+-)-Isomer,Fenfluramine, R-Isomer,Isomeride,Pondimin,Fenfluramine Hydrochloride, R Isomer,Fenfluramine, R Isomer,Hydrochloride, Fenfluramine
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000293 Adolescent A person 13 to 18 years of age. Adolescence,Youth,Adolescents,Adolescents, Female,Adolescents, Male,Teenagers,Teens,Adolescent, Female,Adolescent, Male,Female Adolescent,Female Adolescents,Male Adolescent,Male Adolescents,Teen,Teenager,Youths
D001321 Autistic Disorder A disorder beginning in childhood. It is marked by the presence of markedly abnormal or impaired development in social interaction and communication and a markedly restricted repertoire of activity and interest. Manifestations of the disorder vary greatly depending on the developmental level and chronological age of the individual. (DSM-V) Autism, Infantile,Kanner's Syndrome,Autism,Autism, Early Infantile,Disorder, Autistic,Disorders, Autistic,Early Infantile Autism,Infantile Autism,Infantile Autism, Early,Kanner Syndrome,Kanners Syndrome

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