Pepcid® (famotidine) for autistic spectrum disorders

	TITLE: Famotidine treatment of young children with autistic spectrum disorders: Pilot research using single subject research design.
	AUTHORS: Linday LA, Tsiouris JA, Cohen IL, Shindledecker R, DeCresce R.
	JOURNAL: Journal of Neural Transmission 2001;108(5):593-611.

ABSTRACT:

Using single subject research design, we performed pilot research to evaluate the safety and efficacy of famotidine for the treatment of children with autistic spectrum disorders. We studied 9 Caucasian boys, 3.8-8.1 years old, with a DSM-IV diagnosis of a pervasive developmental disorder, living with their families, receiving no chronic medications, and without significant gastrointestinal symptoms. The dose of oral famotidine was 2 mg/kg/day (given in two divided doses); the maximum total daily dose was 100 mg. Using single-subject research analysis and medication given in a randomized, double-blind, placebo-controlled, cross-over design, 4 of 9 children randomized (44%) had evidence of behavioral improvement. Primary efficacy was based on data kept by primary caregivers, including a daily diary; daily visual analogue scales of affection, reciting, or aspects of social interaction; Aberrant Behavior Checklists (ABC, Aman); and Clinical Global Improvement scales. Children with marked stereotypy (meaningless, repetitive behaviors) did not respond. Our subjects did not have prominent gastrointestinal symptoms and endoscopy was not part of our protocol; thus, we cannot exclude the possibility that our subjects improved due to the effective treatment of asymptomatic esophagitis. The use of famotidine for the treatment of children with autistic spectrum disorders warrants further investigation.

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Beginning with the 54th Edition (2000), the Physicians' Desk Reference (PDR) contains extensive information regarding the use of PepcidÒ (famotidine) for children. The dose used in the famotidine/autism research is the same as the highest pediatric dose for gastroesophageal reflux disease (GERD) with or without esophagitis. Your/your child's physician will have ready access to this information.

As noted in the following abstract, there is a high incidence of esophagitis in children with autism:

	TITLE: Gastrointestinal abnormalities in children with autistic disorder.
	AUTHORS: Horvath K, Papadimitriou JC, Rabsztyn A, Drachenberg C, Tildon JT.
	JOURNAL: Journal of Pediatrics 1999 Nov;135(5):559-63.
	Comment in: Journal of Pediatrics 1999 Nov;135(5):533-5

ABSTRACT:

OBJECTIVES: Our aim was to evaluate the structure and function of the upper gastrointestinal tract in a group of patients with autism who had gastrointestinal symptoms. STUDY DESIGN: Thirty-six children (age: 5.7 +/- 2 years, mean +/- SD) with autistic disorder underwent upper gastrointestinal endoscopy with biopsies, intestinal and pancreatic enzyme analyses, and bacterial and fungal cultures. The most frequent gastrointestinal complaints were chronic diarrhea, gaseousness, and abdominal discomfort and distension. RESULTS: Histologic examination in these 36 children revealed grade I or II reflux esophagitis in 25 (69.4%), chronic gastritis in 15, and chronic duodenitis in 24. The number of Paneth's cells in the duodenal crypts was significantly elevated in autistic children compared with non-autistic control subjects. Low intestinal carbohydrate digestive enzyme activity was reported in 21 children (58.3%), although there was no abnormality found in pancreatic function. Seventy-five percent of the autistic children (27/36) had an increased pancreatico-biliary fluid output after intravenous secretin administration. Nineteen of the 21 patients with diarrhea had significantly higher fluid output than those without diarrhea. CONCLUSIONS: Unrecognized gastrointestinal disorders, especially reflux esophagitis and disaccharide malabsorption, may contribute to the behavioral problems of the non-verbal autistic patients. The observed increase in pancreatico-biliary secretion after secretin infusion suggests an upregulation of secretin receptors in the pancreas and liver. Further studies are required to determine the possible association between the brain and gastrointestinal dysfunctions in children with autistic disorder.

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	TITLE: Oral famotidine: A potential treatment for children with autism.
	AUTHOR: Linday LA.
	JOURNAL: Medical Hypotheses 1997;48:381-386.
	(This is Dr. Linday's original hypothesis paper.)

ABSTRACT:

Famotidine (Pepcid®), a histamine-2 receptor blocker, is marketed for the treatment of peptic ulcer disease, gastroesophageal reflux, and the treatment of pathological hypersecretory conditions including the Zollinger-Ellison Syndrome. Recent reports indicate that it is also effective in relieving the deficit (or withdrawal) symptoms of adults with schizophrenia. Autism, a neuropsychiatric disorder which presents within the first few years of life, is defined by deficient social interaction, communication, language, play, and a markedly restricted repertoire of activities and interests. Similarities between the deficit symptoms of schizophrenia and the social deficit symptoms of autism suggest the hypothesis that famotidine may be useful in treating children with autism. Histamine serves as a neurotransmitter and neuromodulator in the brain. H2-receptors in the brain predominantly transmit inhibitory signals; when these receptors are stimulated in animals, spontaneous activity and exploratory behavior decrease; blockade of H2-receptors would therefore be expected to reverse this inhibition.

This research was also presented at two major US/International meetings:

	TITLE: Famotidine treatment of three children with autistic spectrum disorders (Abstract).
	AUTHORS: Linday LA, Cohen IL, Tsiouris JA, DeCresce R.
	IN: Scientific Proceedings, 44th Annual Meeting of the American Academy of Child and Adolescent Psychiatry, Toronto, Canada, October 14-19, 1997, NR-125.

	TITLE: Famotidine treatment of young children with autistic spectrum disorders (Abstract).
	AUTHORS: Linday LA, Tsiouris JA, Cohen IL, DeCresce R.
	IN: New Research Program and Abstracts, American Psychiatric Association 152nd Annual Meeting, May 15-20, 1999, Washington, DC; NR 378.

DISCLAIMER:

The information contained on this web site is provided for educational purposes only; it is a general reference for both health-care consumers and providers; it is not a prescription for any single individual. A high dose of famotidine (Pepcid®) was used in the research discussed on this web site; treatment with this high dose should only be undertaken under the direction of your/your child's prescribing physician. Please print this information and bring it to your/your child's prescribing physician to determine whether this treatment is indicated for you/your child. Please be aware that the use of famotidine to treat children with autistic spectrum disorders is considered "off-label" use in the US because the US Food and Drug Administration has not specifically approved famotidine either for use in children or for the treatment of autistic spectrum disorders. This web site is not affiliated with Merck & Co., Inc. Any opinions expressed on this web site are Dr. Linday's, and do not necessarily reflect those of her affiliated institutions.

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