Pepcid® (famotidine) for autistic spectrum disorders

Famotidine was marketed in the United States (US) in 1986 by Merck & Co., Inc. under the brand name Pepcidâ (a registered trademark of Merck & Co., Inc.). Famotidine blocks the histamine-2 receptor. The US Food and Drug Administration (FDA) originally approved famotidine for the treatment of adults with gastrointestinal conditions such as peptic ulcer disease, esophagitis, and gastroesophageal reflux disease or GERD (also known as esophageal reflux; associated with "heartburn"). It has been available over-the-counter in the US since 1995; "over-the-counter" means that a prescription is not required. After the US patent expired, generic forms of famotidine became available in the US in 2001. A generic drug has the same active chemical (famotidine), but it is made by a different company, and cannot be sold under the original company’s brand name. Merck still markets it’s brand name "Pepcid," but other companies now sell generic famotidine.

Dr. Linday first conceived the idea that treatment with famotidine might be helpful for children with autistic spectrum disorders in 1993. By 1995, Dr. Linday had identified her collaborators, and was able to begin the time-consuming work of writing protocols, obtaining approval from the Institutional Review Board, submitting the research to the US Food and Drug Administration (FDA), writing grants, and identifying children for the studies. Subjects (patients) were active in the research studies from 1996 through 1998. Dr. Linday presented portions of this research at two national medical meetings, and the final paper was published in the Journal of Neural Transmission in May 2001. Click Abstracts for the list of publications/abstracts that have resulted from this research.

Merck & Co., Inc. donated the famotidine (Pepcidâ ) oral suspension used in this research. The research was supported in part by the Institute for Basic Research in Developmental Disabilities (Staten Island, N.Y.), of the New York State Office of Mental Retardation and Developmental Disabilities; the research was performed at this institution.

In the past, Dr. Linday has been contacted by numerous parents who wanted to give famotidine to their child without the guidance of a physician. (As discussed above, famotidine is available without a prescription in the US.) Based on the information contained in the abstract, some of these families grossly miscalculated the dose of famotidine, and one family would have given their child FOUR TIMES the correct dose of famotidine. Furthermore, there is always the possibility of an adverse reaction to a medication.

Dr. Linday is a physician (medical doctor; M.D.). According to current medical practice, a physician may only prescribe for a person that he/she has examined. If a physician has not examined a patient, the physician may not prescribe a supplement or a medication for that patient whether by e-mail, telephone or regular mail; this is true even if the supplement is available in a health food store or the medication is available over-the-counter in a drugstore. Recently, some medications have become available over the Internet, but this is considered controversial.

Therefore, please DO NOT contact Dr. Linday requesting that she provide you with the dose of famotidine for your child. The purpose of this web site is to provide you with information that you can share with your child's prescribing physician, so that you may decide together whether famotidine is an appropriate treatment for your child.

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 (Pepcidâ) 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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