What Pharmacists Need to Know About Hidden Sources of Gluten and Drugs in Development for Celiac Disease

What Pharmacists Need to Know About Hidden Sources of Gluten and Drugs in Development for Celiac Disease

Hidden Sources of Gluten and Drugs in Development for Celiac DiseaseMany people with celiac disease are going to be surprised and discouraged to learn that they may have ongoing intestinal damage even though they follow a strict gluten-free diet and feel fine. One significant reason for the problem is hidden gluten, which is so pervasive in unexpected sources—like medications—that it’s hard to avoid.

Researchers are beginning to discover biomarkers for celiac disease, which will ultimately lead to medications. While patients wait for treatment options, pharmacists can help them prevent serious health problems from ongoing gluten damage by monitoring for hidden sources of gluten in medications.

Current Concerns About the Gluten-Free Diet

Don’t get the wrong idea—there’s nothing wrong with the gluten-free diet and it’s still the best and only treatment for celiac disease—the problem lies in the fact that people with celiac disease can do their diligent best to follow a strict gluten-free diet, yet continue to have intestinal damage.

In November 2016, a study published in the Journal of Pediatric Gastroenterology and Nutrition reported that nearly 20 percent of children diagnosed with celiac disease had persistent enteropathy in spite of following a gluten-free diet for an average of 2.4 years.1 This study also uncovered another important piece of information. The researchers studied tests used to monitor the intestinal health of children with celiac disease and found that the standard test—a tissue transglutaminase (tTG) test—isn’t a reliable indicator. When these children were biopsied, tTG levels were elevated in only 43 percent of those with persistent intestinal damage—it was also elevated in 32 percent of those with mucosal recovery.

The fact that 1 out of 5 children with celiac disease continue to have small intestine damage raises critical questions about their health. These children may have unknown nutrient deficiencies that affect growth and development. Additionally, ongoing intestinal damage may become intractable to the gluten-free diet, which in the long run can lead to cancer.

The problem also affects adults. In fact, the pediatric study was inspired by ever-growing evidence that many adults with celiac disease think they’re healthy because symptoms have disappeared and their tTG levels are normal. Then when they have a biopsy, it shows persistent enteropathy. So why do patients who report being careful to avoid gluten continue to have intestinal damage? It’s possible that some of them slip-up occasionally, but many are inadvertently consuming hidden gluten. While current research estimates that about 30 percent of those with non-responsive celiac disease consume hidden gluten, some experts believe as many as half of adults fall into this category.2

Hidden Sources of Gluten in Food

It’s easier for patients to follow a gluten-free diet today than it was a decade ago. Back then, they had to make their own alternative flour mixes and all baked goods had to be produced at home. Now grocery stores carry diverse gluten-free products and in 2014, the FDA defined and decided to regulate the amount of gluten allowed in foods that are labeled as gluten-free. But there are still numerous ways for hidden gluten to sneak into a diet and there’s only one way to avoid it: patients must read the list of ingredients on each product they buy and hope that they catch every possible source.

Advise patients to check labels and avoid these ingredients that may contain gluten:3

  • Hydrolyzed protein – may be called hydrolyzed vegetable protein or hydrolyzed plant protein
  • Autolyzed yeast
  • Modified food starch
  • Dextrin – maltodextrin
  • Textured vegetable protein
  • Caramel color
  • Malt (malt vinegar, malt flavoring)

Gluten commonly hides in commercially prepared sauces and gravies, soups, processed meat, vegetarian meat alternatives, processed potatoes and scrambled eggs prepared in restaurants, where they may use pancake mix or other wheat-containing products to add bulk.

Gluten Hidden in Supplements and Medications

You already know that gluten hides in excipients used in dietary supplements and medications, but it can still be hard to track down because manufacturers aren’t required to disclose gluten on package labeling. However, it should be in the list of ingredients and if there’s any doubt, you can call the manufacturer. Starch is often a source of gluten in excipients, which includes starch derived wheat, barley, rye, triticale, farina, and spelt. On the flip side, starch that comes from rice, tapioca or potatoes is safe because they’re naturally gluten free.

This list includes some of the most common sources of hidden gluten in medications. Remember that dietary supplements may contain any of the ingredients in the food and medication lists:4

  • Modified starch
  • Pregelatinized starch
  • Sodium starch glycolate
  • Dextrin
  • Dextrate
  • Dextri-maltose
  • Maltodextrin

Your job is a little easier thanks to a list developed by the University of Kansas Drug Information Center that shows the gluten status of 200 drugs.5 Another resource to use is GlutenFreeDrugs.com, which is maintained by a clinical pharmacist and provides comprehensive information, including whether the manufacturer believes the drug is free of gluten, but can’t make guarantees because they don’t do final tests.6

Biomarker Identification and Drugs in Development

It’s reasonable to believe that medications may become available that will eliminate the need to worry about dietary gluten, as experts are starting to find biomarkers for celiac disease and they’re bringing investigational drugs into clinical trials. In December 2016, Digestive Diseases and Sciences published two biomarker studies from the same group of researchers. One reported the discovery that elevated serum levels of a protein encoding gene, syndecan-1, are associated with mucosal damage in children with celiac disease.7 The second study concluded that levels of zonulin (a protein that regulates junctions between cells in the intestine) correlate with the density of enteroviruses and immunoregulatory cells, which indicate intestinal permeability in patients with celiac disease.8

Meanwhile, in March 2016, Celimmune started screening patients for two Phase 2 clinical studies.9 One will test its investigational product, AMG 714, in patients with refractory celiac disease, while the other will test the same drug in those with non-responsive celiac disease. AMG 714 is an anti-IL-15 monoclonal antibody that may be an effective treatment because the interleukin 15 cytokine is believed to trigger inflammation in the intestinal wall.

Patients Rely on Pharmacists to Target Hidden Sources of Gluten

Legislation is in the works that would require gluten to be disclosed on medication labels, but until that becomes a reality, pharmacists must be vigilant about potential gluten in medications prescribed to patients with celiac disease. Since many celiac patients can’t rely on symptoms to know if their gut is healthy, they rely on your intervention to help ensure they’re actually following a 100 percent gluten-free diet.

Pharmaceutica North America provides prescription drug products including diclofenac sodium and lidocaine ointment, a diverse line of high-quality active pharmaceutical ingredients, and OTC supplements. Contact us today to talk about how we can support your pharmaceutical needs.

Show 9 footnotes

  1. “Value of IgA tTG in Predicting Mucosal Recovery in Children with Celiac Disease on a Gluten Free Diet,” November 2016, http://journals.lww.com/jpgn/Abstract/publishahead/Value_of_IgA_tTG_in_Predicting_Mucosal_Recovery_in.97326.aspx
  2. “Up to Half of Patients May Not Fully Respond to a Gluten-Free Diet,” September 2016, http://www.beyondceliac.org/research-news/View-Research-News/1394/postid–54909/
  3. “Uncovering Hidden Sources of Gluten – What Clients and Patients Must Know,” June 2014, http://www.todaysdietitian.com/newarchives/060114p18.shtml
  4. “Medication and Supplement Use in Celiac Disease,” December 2014, https://www.uspharmacist.com/article/medication-and-supplement-use-in-celiac-disease
  5. “Gluten Content of Top 200 Drugs: Key Information for Pharmacists,” June 2016, http://www.pharmacytimes.com/news/gluten-content-of-top-200-drugs-key-information-for-pharmacists
  6. “Gluten-Free Drugs,” September 2016, http://glutenfreedrugs.com/
  7. “Soluble Syndecan-1: A Novel Biomarker of Small Bowel Mucosal Damage in Children with Celiac Disease,” December 2016, https://www.ncbi.nlm.nih.gov/pubmed/28025744
  8. “Circulating Zonulin Correlates with Density of Enteroviruses and Tolerogenic Dendritic Cells in the Small Bowel Mucosa of Celiac Disease Patients,” December 2016, https://www.ncbi.nlm.nih.gov/pubmed/27995404
  9. “Celimmune Commences Screening in Phase 2 Clinical Study in Refractory Celiac Disease Type II,” March 2016, http://www.prnewswire.com/news-releases/celimmune-commences-screening-in-phase-2-clinical-study-in-refractory-celiac-disease-type-ii-300243818.html
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