Autism & Developmental

Fenfluramine treatment of twenty children with autism.

Ekman et al. (1989) · Journal of autism and developmental disorders 1989
★ The Verdict

Fenfluramine is not a useful autism treatment—tiny motor gains, no cognitive benefit.

✓ Read this if BCBAs who field parent questions about pills, supplements, or off-label drugs.
✗ Skip if Clinicians only running evidence-based ABA with no medication discussions.

01Research in Context

01

What this study did

Doctors gave twenty autistic children fenfluramine pills for forty-eight weeks. They watched if the drug cut odd movements or raised IQ scores.

Half the kids got real pills first, then placebo. The other half got the reverse order. No one knew which pill was which until the end.

02

What they found

The drug only trimmed a few repetitive body motions. It did not lift test scores or help language.

After almost a year, the changes were too small to matter in daily life.

03

How this fits with other research

Meyer et al. (1987) looked at five kids two years earlier. They saw bigger drops in Valsalva-type breathing tics. The 1989 trial used tighter rules and found weaker gains, showing the first hopeful signs may have been luck.

Bent et al. (2011) and Jones et al. (2010) tested other oral pills—omega-3 and digestive enzymes—in similar double-blind styles. Like fenfluramine, those pills also left core autism symptoms unchanged.

Höfer et al. (2017) and Saral et al. (2023) report that up to nine in ten families still try non-Rx pills or diets. The old fenfluramine data warn that “natural” or “pill” does not equal “effective.”

04

Why it matters

When parents ask about supplements or old drugs, you can share this clear evidence: fenfluramine barely touched motor tics and did nothing for cognition or language. Use the data to steer families toward interventions with stronger backing—like ABA, speech, or sleep plans—and always check what else they are giving.

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Add fenfluramine to your “ineffective” list when parents ask about old medical studies.

02At a glance

Intervention
not applicable
Design
randomized controlled trial
Sample size
20
Population
autism spectrum disorder
Finding
weakly positive
Magnitude
small

03Original abstract

The effects of fenfluramine were examined on 20 children with autism over a 48-week period utilizing a double-blind placebo-controlled crossover design. Blood and urine samples and psychological tests (Griffith's Developmental Scales and Real Life Rating Scale) were obtained at each crossover period. The only significant improvement was a decrease in abnormal motor behavior. We did not find any significant improvement in intellectual functioning or any correlation between good clinical response and low baseline serotonin levels or high baseline IQ. Serotonin decreased 53% after fenfluramine treatment and rebounded to a level 35% higher than baseline following a placebo period. Fenfluramine and the active metabolite norfenfluramine were determined in plasma samples.

Journal of autism and developmental disorders, 1989 · doi:10.1007/BF02212855