Pharmaceutical Product Labeling: Gluten StatusFrom: Verrico, Peg [VerricoMM@upmc.edu] Sent: Thursday, November 06, 2003 5:27 PM To: Dockets, FDA Subject: Pharmaceutical Product Labeling: Gluten Status Please consider making a recommendation to pharmaceutical companies to include gluten status ("gluten free" or "not gluten free") on their prescription and nonprescription product labeling. The support for this recommendation is outlined below: Celiac disease, also known as gluten intolerance, is a genetic disorder that affects a minimum of 1 in 1331 Americans. Symptoms of celiac disease can range from the classic features, such as diarrhea, weight loss, and malnutrition, to latent symptoms such as isolated nutrient deficiencies but no gastrointestinal symptoms. The disease mostly affects people of European (especially Northern European) descent, but recent studies show that it also affects Hispanic, Black and Asian populations as well. Those affected suffer damage to the villi (shortening and villous flattening) in the lamina propria and crypt regions of their intestines when they eat specific food-grain antigens (toxic amino acid sequences) that are found in wheat, rye, and barley. Establishing the diagnosis of subclinical celiac disease is of potential importance for four reasons: the danger of malignancy, the presence of unsuspected nutritional deficiencies, the association with low-birth weight infants in affected mothers, and the occurrence of autoimmune disorders. The risk of malignancy in patients with subclinical celiac disease is not known. However, once the disease is under remission with a gluten-free diet, the risk approaches that of the normal population. Some studies have found that the prevalence of autoimmune diseases (eg, Type 1 diabetes mellitus, collagen vascular disease, autoimmune thyroiditis) is related to the duration of undetected celiac disease, and may reach more than 30 percent of patients diagnosed after age 20. Oligosymptomatic patients with celiac disease may have significant nutritional deficiencies. The, mostly oligosymptomatic, celiacs detected by screening of the Italian population described above exhibited a number of important clinical and laboratory findings such as iron deficiency, recurrent abdominal pain, and mood changes. In one study, 31 percent of patients with subclinical disease (versus 67 percent with classic symptoms) were malnourished. Once on a gluten-free diet, all reported objective and subjective improvement of well-being, realizing symptoms that they had not recognized before. Celiac disease is frequently associated with dermatitis herpetiformis, Down syndrome, selective IgA deficiency, and other conditions which have autoimmune features such as type 1 diabetes mellitus, thyroid disease, and liver disease. The only acceptable treatment for celiac disease is strict adherence to a 100% gluten-free diet for life. An adherence to a gluten-free diet can prevent almost all complications caused by the disease. A gluten-free diet means avoiding all products that contain wheat, rye and barley, or any of their derivatives. This is a difficult task as there are many hidden sources of gluten found in the ingredients of many processed foods and medications. Patients with celiac disease and the pharmacists who care for them face much difficulty due to the lack of information available about the status of gluten content in the pharmaceutical products that they may be prescribed to receive. Manufacturers of food products are obligated to list whether their products contain wheat, rye, barley, oats and/or gluten on their products containing such substances. However, pharmaceutical products are not required to provide this same labeling. Therefore, it is often necessary for pharmacists to contact pharmaceutical manufacturers directly to determine if a product is gluten-free. This is a time consuming process. In addition, pharmaceuticals companies are not available seven days a week and 24 hours each day. Therefore, when a medication is urgently needed for a patient with Celiac Sprue disease, pharmacists may not be able to appropriately and immediately confirm that the associated product that they have in stock to dispense is gluten free. Including the gluten status on pharmaceutical product labeling is a much needed patient safety effort. Please contact me if you have questions or comments about this request. Thank you. Sincerely, Peg Verrico, RPh Drug Information Pharmacist University of Pittsburgh Drug Information Center 137 Victoria Hall Pittsburgh, PA 15261 Phone: (412) 624-4987 Fax: (412) 624-6350 verricomm@msx.upmc.edu The information contained in this email message is intended only for the personal and confidential use of the recipients named above. Its contents are privileged and confidential. Any unauthorized or improper disclosure, copying, distribution or use of the contents of this e-mail is prohibited. If the reader of this message is not the intended recipient or an agent responsible for delivering it to the intended recipient, you are hereby notified that you have received this document in error and that any dissemination, distribution or copying of this message is strictly prohibited. If you have received this communication in error, please notify me immediately by e-mail, and delete the original message.