Celiac Support Association Position on FDA-2011-N-0842
CSA supports eliminating ALL ingredients derived from gluten sources, from ALL forms of 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 acid sequences that evoke the immune mediated T and B cell responses in those with celiac disease. These amino acid sequences are ubiquitous in the grasses of the genus triticum, hordeum, secale, and to a lesser amount in avena plants.[i] [ii] [iii] Oats should also be eliminated from medications to fully protect all people with celiac disease because the toxicity depends upon the variety of the oats.[iv] The toxic amount of gluten for any one person is truly not known.
The only accepted treatment for celiac disease is lifelong adherence to a gluten-free lifestyle defined as strict elimination of foods, beverages, medications, supplements and 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, “the tolerable daily intake level for gluten in individuals with celiac disease was determined in a safety assessment to be 0.4 mg gluten/day for adverse morphological effects and 0.015 mg gluten/day for adverse clinical effects.” [v] The toxic amount of gluten for any one person is truly not known.
The use of the term gluten-free in drugs and supplements is not standardized. The “celiac safe” communication system with drug companies related to active, inactive ingredients and processing agents has deteriorated. The ability for company representatives to confirm the presence or lack of presence of derivatives from wheat, barley, rye or oats has worsened since 2008.
On December 21, 2011, FDA’s Center for Drug Research and Evaluation (CDER) issued a Federal Register notice (76 FR 79196) to request information and public comments on a series of questions related to the presence of gluten in drug products (i.e., prescription, nonprescription, biologic, and homeopathic drug products). CDER is considering the public comments it received in response to this notice as it evaluates options to help individuals with celiac disease limit gluten exposure from consumption of drug products. CSA supports the Citizen Petition submitted by Michael Weber, June 2008 in docket references.
There is no down side to eliminating gluten from human medications. Elimination of the ingredients with the toxic amino acid sequences that evoke the systemic immune mediated responses 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 Support 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 with gluten induced health conditions, the Celiac Support Association strongly endorses the elimination of ingredients derived from wheat, barley, rye and common oats in all human medications.
CSA Letter to Dockets: Submitted by Mary Schluckebier, Executive Director
[i] M. Southan1 and F. MacRitchie.Molecular Weight Distribution of Wheat Proteins. ABSTRACT Cereal Chem Vol. 76, No. 6, 1999 76(6):827–836
[ii] Cristina Mitea, Elma M. J. Salentijn, Peter van Veelen1, Svetlana V. Goryunova, Ingrid M. van der Meer, Hetty C. van den Broeck, Jorge R. Mujico1, Veronica Monserrat1, Luud J. W. J. Gilissen, Jan Wouter Drijfhout, Liesbeth Dekking, Frits Koning, Marinus J. M. Smulders. A Universal Approach to Eliminate Antigenic Properties of Alpha-Gliadin Peptides in Celiac Disease. PLoS ONE. December 2010, Volume 5, Issue 12, e15637
[iii] Gianfranco Mamone, Francesco Addeo, Una Chianese, Aldo Di Luccia,Alessandra De Martino, Annunziata Nappo, Annarita Formisano,Pasqualina De Vivo and Pasquale FerrantiJ. Characterization of wheat gliadin proteins by combinedtwo-dimensional gel electrophoresis and tandem mass spectrometry. ProteomiCB 2006, 6. 2869-2865
[iv] Comino I, Real A, de Lorenzo L, Cornell H, López-Casado MÁ, Barro F, Lorite P, Torres MI, Cebolla A, Sousa C. Diversity in oat potential immunogenicity: basis for the selection of oat varieties with no toxicity in coeliac disease. Gut. 2011 Jul;60(7):915-22. Epub 2011 Feb 12.
[v] The references listed with the FDA Docket 2011-N-0842 specifically cited in the narrative “Health Hazard Assessment” document and the Citizen Petition submitted by Michael Weber, June 2008.