People with celiac disease and gluten sensitivity have described problems with unlabeled gluten in medication for years, but to date there has been no scientific evidence to persuade regulators to require manufacturers to label the source of their ingredients in medicine. But that may change.
Last November, the National Foundation for Celiac Awareness (NFCA) announced that it would conduct a first-of-its-kind research study on gluten in medications, funded by the U.S. Food and Drug Administration (FDA). NFCA, partnering with St. John's University College of Pharmacy and Allied Health Professions, is conducting this research in two parts. The first part of the study is happening now: a survey of the celiac and gluten sensitive populations.
NFCA’s Gluten in Medications Survey is available at www.CeliacCentral.org/Survey. NFCA urges all people who are following a gluten-free diet to participate. Participants will be asked about their experiences taking medicine. They will also be asked to share information if they think they might have had a gluten-related reaction to an over-the-counter or prescription medicine.
Results from the survey will guide the second phase of the study: our team will test some of the medicines identified in the survey to see if they contain gluten.
This critically needed preliminary research aims to validate or nullify the anecdotal adverse experiences associated with gluten in medications that have been reported by people with celiac disease and gluten sensitivity.
The FDA is funding this research study through its Safe Use Initiative, which has the goal to identify and reduce preventable harm from medications. NFCA has been advocating for unlabeled gluten in medication to be considered as a "candidate case" of preventable harm for a couple of years. We shared anecdotal reports of people's experiences with gluten in medication through oral testimony and written comment, and we participated in a public workshop. The study aims to validate or nullify the assertion that unlabeled gluten in medication is problematic. It is a first step to determine if more investigation is needed in this area, through which additional research, labeling, and safe use guideline initiatives can advance. More information about the Safe Use Initiative can be found at www.fda.gov/safeuseinitiative.
Please share this opportunity to participate in this ground-breaking research with everyone in your gluten-free circles, and encourage them to take the survey. The survey takes between 4-15 minutes to complete. It closes on February 28, 2012.