Celiac disease, an autoimmune disease caused by gluten, a protein found in wheat, barley, and rye, affects nearly three million Americans; ingestion of this gluten, which is toxic to them, results in an attack of the villi which line the small intestines, preventing proper absorption of vital nutrients and resulting in a wide variety of painful physical and mental symptoms. Although gluten labeling laws and increased gluten awareness have resulted in an easier gluten-free lifestyle, there still remains the matter of medications. Even though prescription and over-the-counter drugs can contain gluten, capable of making 1 in 100 Americans seriously ill, no clear gluten labeling is required by the FDA, a fact which NFCA (the National Foundation for Celiac Awareness) is actively working to remedy.
In my work as an author, researcher, and gluten-free advocate, I work hard to help the gluten-sensitive and celiac communities and have been pleased to note a marked increase in gluten-free awareness over the past several years since my own celiac diagnosis. The celiac community has made several strides forward with stricter gluten labeling laws, more companies devoted to manufacturing gluten-free alternatives, and helpful online resources. Now it’s time to focus our attention on extending gluten labeling laws to medications, a fact which can prevent putting celiac patients at risk.
Concerned about medication risks, the FDA has already launched a Safe Use Initiative, in which the FDA, according to its website, “seeks to partner and collaborate with relevant stakeholders to measurably reduce preventable harm from medications, thereby improving patient health.” From the NFCA have emerged Alice Best, Founder and President, and Loretta Jay, M.A., the Director of Program Development, who are working extend the FDA’s medication initiative to the benefit of celiac patients. “The Safe Use Initiative’s emphasis on informational errors makes this project particularly important to people with celiac disease and gluten sensitivity.”
“Although few medications do contain gluten, every medication must be investigated to verify its gluten-free status,” say Best and Jay. The current situation requires that pharmacists and patients contact the pharmaceutical manufacturers themselves to inquire about gluten content. “Answers are not available after regular business hours, and sometimes manufacturers are not prepared with the responses when contacted during the day,” Best and Jay write. The information can also change easily as pharmaceuticals are manufactured differently. Whereas time-consuming research can be inconvenient for celiac patients when it comes to food products, it can be a health-threatening matter when dealing with medication.
Jay believes that it will be a long process, but the NFCA will continue to take up the issue with the FDA. In the meantime, celiac patients and pharmacists will have to continue their diligent and time-consuming research on their own. As the celiac community and its advocates, such as the NFCA, have experienced many wins over the years in their quest for celiac and gluten-free awareness, I believe we can look forward to a future in which our medications, prescription or not, are clearly labeled regarding their gluten content.
FDA: FDA’s Safe Use Initiative http://www.fda.gov/downloads/Drugs/DrugSafety/UCM188961.pdf
Regulations.gov: National Foundation for Celiac Awareness (NFCA) http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480b0e253
From our home to yours, Tina Turbin.