What if something in the medicine your doctor prescribes might make you sick, and neither your doctor nor pharmacist could tell what it is? This is a very real problem for the 3 million Americans with celiac disease and millions more with non-celiac gluten sensitivity (NCGS).[i] Neither population tolerates gluten, the protein found in wheat, barley and rye.
Celiac disease is a genetic autoimmune disease that impacts multiple body systems and results in damage to one's gastrointestinal tract; people with NCGS may experience similar adverse reactions to gluten as those with celiac, but without the autoimmune reaction or gastrointestinal damage. The food industry has caught on. Our supermarket shelves are now lined with an array of gluten-free treats to meet the increasing demand. Even restaurants in the know and eager to grow their customer-base have trained their staff in safe gluten-free food preparation and menu development.
When it comes to meeting the needs of the gluten-free population, the pharmaceutical industry lags behind. Gluten may be used as a filler or coating in medication. Even very small amounts of unintentionally consumed gluten, such as what would be ingested from gluten-containing drug products, may cause harm to those who follow a medically required gluten-free diet.[ii] [iii] [iv]
The problem is that the Food and Drug Administration (FDA) doesn't require drug manufacturers to list the source of the inactive ingredients in their products. Without labeling, patients, pharmacists and prescribers don't know if their medicine contains gluten unless they investigate. For example, the ingredient list might say "starch." This starch may be derived from wheat (gluten), or another grain like corn. The needed information is rarely available on the manufacturer's website and sometimes a phone call during business hours doesn't yield the answers in a timely manner. Even more frustrating is that while one batch of a drug may be deemed free from wheat, the next batch may not be, and the label doesn't reflect the change of ingredients. Each prescription refill calls for the investigation to start anew.
Representatives Tim Ryan (OH) and Nita Lowey (NY) submitted a Bill to Congress that will address this problem. The Gluten in Medicine Identification Act of 2012[v] requires drug manufacturers to identify the source of inactive ingredients in drug products. Yippee!
May is Celiac Awareness Month. Here is something that everyone can do to observe this time and make a difference. Contact your US Representative and ask them to co-sponsor HR4972, The Gluten in Medicine Identification Act of 2012. It is easy, and takes just a minute - literally! Click here, and you'll be brought to an Action Alert hosted by the American Celiac Disease Alliance. Just enter your zip code and name, and the system does the rest. It's as easy as a gluten-free piece of pie.
[i] Fasano, A, et al. Divergence of gut permeability and mucosal immune gene expression in two gluten-associated conditions: celiac disease and gluten sensitivity. BMC Medicine 2011; 9:23.
[ii] Catassi C, Fabiani E, Iacono G, et al. A prospective, double-blind, placebo-controlled trial to establish a safe gluten threshold for patients with celiac disease. Am J Clin Nutr 2007; 85:160-6.
[iii] Akobeng AK, Thomas, AG. Systematic review: Tolerable amount of gluten for people with coeliac disease. Aliment Pharmacol Ther 2008; 27:1044-1052.
[iv] Mangione, RA, Patel PN, Shin E, Fiebert, J. Pharmaceutical Care of Celiac Disease, US Pharm 2011; 36(12):30-33
[v] H.R. 4972--112th Congress: Gluten in Medicine Identification Act of 2012. (2012). In GovTrack.us (database of federal legislation). Retrieved May 22, 2012, from http://www.govtrack.us/congress/bills/112/hr4972