Gluten Content of the Top 200 Medications: Follow-Up to the Influence of Gluten on a Patient’s Medication Choices

Celiac sprue is an autoimmune disease affecting the digestive system and occurs when gluten proteins, commonly found in wheat, barley, and rye, are not fully digested, stimulating an inflammatory process in the small intestine.1-3 Symptoms can appear at any point in life and can range from gastrointestinal upset, headache, low weight gain (weight loss), osteoporosis, depression, and infertility.1-4 Due to the variety of symptoms, celiac sprue is often underdiagnosed.1,2 Current estimates find that the disease affects 1 out of every 100 to 133 Americans.1,2,4,5 Treatment for celiac sprue includes complete avoidance of gluten in products that are ingested or come into contact with the mouth, including medications, lip balm, and Play-Doh.1-7 Ingestion of amounts as small as 30 to 50 mg may illicit an adverse event in patients.8 However, identification of gluten in products can be cumbersome. For food, per the FDA Food Act 2004, identification of wheat (along with milk, egg, fish, crustacean, shellfish, tree nuts, peanuts, and soybeans) on product labels, including flavorings, colorings, or additives contaminated with such, is required. 7 Allergen identification is not required for medications where gluten can be found within the inactive ingredients (such as starches or starch derivatives) or transferred through the manufacturing process.1 Ideally, this information would be contained in the package insert; however, inactive ingredients and manufacturing processes can change or are not fully described. Potential sources of gluten are not always recognized by health care professionals.1 Patients are therefore required to double-check the content of all their medications before ingestion, which can become quite burdensome depending on the number of medications and availability of information because one “good” resource is not available. Pharmacists are in a prime setting for consultation; however, without reliable resources for determining gluten content and adequate time, their job becomes labor intensive. Available resources include a Web site, glutenfreedrugs.com, that is maintained by a clinical pharmacist and contains a list of gluten-free medications, previous lists published by Hospital Pharmacy, and a list of nonprescription drugs published in the Nov/Dec 2011 edition of the Journal of the American Pharmacists Association.6,9 Other resources include the Celiac Disease Foundation (www.celiac.org), Celiac Sprue Association/USE Inc. (www.csaceliacs.org), and National Foundation for Celiac Awareness (www.celiaccentral.org); these Web sites do not contain a list of gluten-free medications, but they maintain education and support for patients. The National Foundation for Celiac Awareness offers a free continuing education program for pharmacists to provide them with a “reliable understanding of celiac disease and their role in dealing with gluten-intolerant patients.” 10 Other continuing education programs are available for allied health professionals, dietitians, mental health professionals, nurse practitioners, and nursing professionals for a nominal fee. These resources are available at www.celiaclearning.com. In addition to answering patient and health care professional questions regarding the gluten content of medications, the University of Kansas Drug Information Center has updated previously published information with the gluten content of the top 200 drugs by total dollars and the top 200 drugs by total prescriptions, as published by Pharmacy Times in July 2012.11 The list was compiled by contacting manufacturers of the respective agents in August 2012 and asking if the [specific] drug was considered to be gluten-free. Manufacturers’ phone numbers were obtained from the Red Book and Facts & Comparisons.12,13 Only answers of “yes” or “no” were accepted, and all “yes” answers required written documentation unless otherwise noted. Companies that declined to participate were recorded as “no” answers. Table 1 summarizes the information found from the manufacturers, and it is a good starting place for practitioners when searching for a gluten-free medication. However, it is essential to double-check with the manufacturer regarding specific products, as inactive ingredients and manufacturing processes can change. The University of Kansas Drug Information Center is available to answer both patient and health care professional questions regarding the gluten content of medications (ude.uk@ofnigurd).