Celiac letter


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Celiac letter

  1. 1. Celiac Sprue Association Position on FDA-2011-N-0842CSA supports eliminating ALL ingredients derived from gluten sources, from ALL formsof human medications. ● When in doubt, celiacs must seek a compounding pharmacy to assure a gluten-free formulation for drugs others commonly buy at the drug store. ● CSA 2007 member survey indicates celiacs consume an average of eight oral medications a day. ● A gluten-free lifestyle is the only prescription for all celiacs.Gluten, in the celiac world, is the inclusive term used to describe the amino acidsequences that evoke the immune mediated T and B cell responses in those withceliac disease. These amino acid sequences are ubiquitous in the grasses of the genustriticum, hordeum, secale, and to a lesser amount in avena plants.[i] [ii] [iii] Oats should also beeliminated from medications to fully protect all people with celiac disease because the toxicitydepends upon the variety of the oats.[iv] The toxic amount of gluten for any one person is trulynot known.The only accepted treatment for celiac disease is lifelong adherence to a gluten-freelifestyle defined as strict elimination of foods, beverages, medications, supplementsand toiletries containing gluten from wheat, barley or rye and to a lesser extent oats..The FDA Hazard Report reviewed the limited non-confirming data and noted on page 45, “thetolerable daily intake level for gluten in individuals with celiac disease was determined in asafety assessment to be 0.4 mg gluten/day for adverse morphological effects and 0.015 mggluten/day for adverse clinical effects.” [v] The toxic amount of gluten for any one person istruly not known.CSA supports the Citizen Petition submitted by Michael Weber, June 2008 in docketreferences.The use of the term gluten-free in drugs and supplements is not standardized. The “celiacsafe” communication system with drug companies related to active, inactive ingredients andprocessing agents has deteriorated. The ability for company representatives to confirm thepresence or lack of presence of derivatives from wheat, barley, rye or oats has worsened since2008.There is no down side to eliminating gluten from human medications. Elimination of theingredients with the toxic amino acid sequences that evoke the systemic immune mediatedresponses is the only method to assure the wellbeing of those diagnosed with celiac disease. ● Such action to eliminate all ingredients derived from gluten sources will remove the consumer fear of not having the information needed to safely choose one brand over another. ● Such action will remove the risk of inadvertent ingestion of “gluten” from fillers, carriers and coatings that delay complete healing or exacerbate the situation. ● Such action provides physicians a choice of the most appropriate drug based upon the active ingredients. ● Such action provides assurance to the pharmacist who can counsel and dispense the medications without concern of cross contamination. ● For those with celiac disease and others living the medically required gluten-free lifestyle a major daily health risk is eliminated. ● Time and health costs are reduced at all levels. (Including the Celiac Sprue Association office and staff time in counseling and perusing accurate information about drugs.)For the health and well being of the increasingly diagnosed celiac population and others withgluten induced health conditions, the Celiac Sprue Association strongly endorses the eliminationof ingredients derived from wheat, barley, rye and common oats in all human medications.Submitted by Mary Schluckebier, Executive Directo