Gluten in Medications: NFCA and the Pharmaceutical Industry
Celiac disease is a genetic, autoimmune disease that damages the small intestines and interferes with the absorption of nutrients from food. When people with celiac ingest gluten, the protein in wheat, barley and rye, the whole body is affected causing a myriad of symptoms. The only treatment for those with celiac disease is to follow a strict gluten-free diet for life. As gluten is found in medication, pharmacy care is critical in the treatment of this disorder.
The Food Allergen Labeling Consumer Protection Act of 2004, which requires packaged food labels to identify all ingredients containing wheat and other common allergens, was a major landmark for people with celiac disease and food allergies. Yet no similar requirement exists for medication labels.
When developing medications, manufacturers use excipients to bind pills together. Excipients are inactive ingredients that help with the delivery of the medication to the patient. There are several types of excipients that drug companies may use, and some of them may contain gluten. Although few medications actually contain gluten, it is important that the ingredients of each medication are explored to determine the source of excipients – and to verify that the particular drug in question is indeed gluten-free. Complicating matters, a generic form of a medication may use different excipients than the brand name drug. This means that even if the brand name is determined to be gluten-free, the gluten-free status of each generic produced by different manufacturers must also be verified.
The following inactive ingredients indicate the need for additional investigation to determine the gluten-free status of the drug:
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Wheat
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Modified starch (source not specified)
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Pregelatinized starch (source not specified)
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Pregelatinized modified starch (source not specified)
What’s Next?
In a perfect, gluten-free world, gluten would be banned as excipients. (It is in Australia and New Zealand!) While that is our ultimate objective, we realize that that is a long way off. NFCA has established relationships, partnerships and joined with other organizations to further its goal of readily available medication that is easily identifiable as gluten-free for people with celiac and gluten intolerance:
1. Consumers are demanding gluten-free products. Packaged Facts reports that the gluten free marketplace will reach $2.6 billion by 2012! Drug manufacturers, recognizing this trend, will want to promote their gluten-free medications as a marketing tool. NFCA’s GREAT Association is a membership organization in which pharmaceutical manufacturers can register their gluten-free drugs. In the spring of 2010 NFCA is launching the Gluten-free Yellow Pages which will include a voluntary, manufacturer-driven list of gluten-free medications.
2. In 2008 NFCA conducted a survey of patients with celiac disease in Philadelphia hospitals. 79% of respondants reported that neither the pharmacist nor the physician was able to determine the gluten-free status of needed medication. NFCA is actively seeking funding to develop a Continuting Medical Education (CME) program for pharmacists and pharmacist technicians that will educate about celiac disease and the identification of gluten in medication. Once developed it will be free to all learners.
Resources:
Information and resources for both practictioners and patients can be found in the Support for Patients and Families section of our website. Click Here.
Learn More:
NFCA is actively pursuing partnerships with stakeholders, memberships with organizations that share our objectives and speaking out on related topics. Learn more about this by visiting the Collaborations, Memberships and Positions Taken page.
Contact Us:
For more information please contact Loretta Jay, Director of Program Development:
E-mail: lorettajay@CeliacCentral.org
Phone: 215.325.1306 x104