Question from a Member:
In people with celiac disease, how important is it for them to avoid medications whose excipients contain gluten (usually in the form of starch or of sugars like dextrose)?
Seems hard to know from one generic to another specifically what’s in the excipients. But is the potential trace amount of gluten in a medication even substantial enough to pose an issue?
Why this is important
1. Celiac disease is an immune-mediated disorder affecting mainly the small intestine in which there is a sensitivity to gluten.
Gluten is found in grains like wheat, barley, rye, etc. Important: very small amounts of gluten can cause problems in persons with celiac disease.
2. Also, so many of our patients are on a gluten-free diet nowadays. So, the question of gluten in medications can arise even in persons who don’t have celiac disease.
Labelling of medications for gluten content
There are standards for how much gluten is contained in different foods. The FDA has defined gluten-free as less than 20 ppm. But, only foods and supplements have to follow this guideline, not medications.
As of July, 2018, the FDA has not set any threshold level for gluten content above which the medication must be labelled as containing gluten. The FDA did issue a draft guidance on “Gluten in Drug Products and Associated Labeling Recommendations” in December, 2017 but it has not been implemented as of July, 2018.
Is gluten in medications a problem?
Patients with celiac disease should take less than a total of 50 mg of gluten per day.
Keep this in mind as you read the following points quoted directly from the FDA’s website (accessed July 13, 2018):
“The majority of oral drug products either contain no gluten or virtually no gluten.”
“Based on information available to the Agency, we are aware of no oral drug products currently marketed in the United States that contain wheat gluten or wheat flour intentionally added as an inactive ingredient. We would expect any such product, if it existed, to include wheat gluten or wheat flour in the list of ingredients in its labeling.
FDA has identified very few oral drugs that contain wheat starch as an ingredient. Starch can also be used as a starting material for manufacturing various ingredients found in oral drugs. Starch used for this purpose is often corn starch or potato starch, not wheat starch. Even if wheat starch were used, either as an ingredient or as a starting material, there would be very little gluten, if any, expected to be present in the ingredient or the drug product. Very few, if any, oral drug products contain ingredients derived from barley or rye.
1. “The vast majority of oral drug products either contain no gluten or virtually no gluten.”
2. “In the very rare cases where gluten may be present, we estimate based on drug formulation information that wheat starch and other ingredients derived from wheat would contribute no more than 0.5 mg gluten to a unit dose of an oral drug product.”
3. “This amount is less than may be found in a single 30-gram serving of food labeled gluten-free according to FDA’s regulations.”
Note: Even if the pill contains 0.5 mg of gluten, this is only a 10th of the threshold above which it could be a problem.
So, the bottomline is that seems unlikely that the amount of gluten in a medication could be a problem–even for patients with celiac disease.
In case of doubt, or to be sure, patients or their pharmacists can contact the manufacturer of the brand name or generic medication for details of the contents of the pill.
Also, here are some resources to look up gluten and medications:
glutenfreedrugs.com (website maintained by a pharmacist)
Optional to read
Medication tablets and capsules contain substances other than the drug itself, called inactive ingredients or excipients.
The excipients are usually listed in the Product Information.
Among these excipients, how do we know if gluten is present and how much? Directly contacting the manufacturer of the medication product is the best and most reliable way to know whether a particular product has gluten in it and, if so, how much (Cruz et al., 2015).
But there are things that we (the clinician, the pharmacists, the patient, etc.) can do on our own to find out the gluten content of medication products.
Why would medication products contain gluten? Because they may contain starch and/or some of its derivatives that contain gluten (Rubal-Peace and Sepp, 2018).
Step 1: Look at the Product Information to see if starch is listed as an inactive ingredient (excipient). If so, is the source of the starch listed? If the starch is from corn, rice, potato, or tapioca, it is probably gluten-free.
But, if it is from wheat, oat, rye, or barley, it probably contains gluten.
(Optional to read: Other sources of gluten include spelt, triticale, einkorn, farro, emmer, or khorasan; Cruz et al., 2015.)
Step 2: Also check to see if one of the derivatives of starch are listed. There are four main ones: dextrans, dextrose, dextrates, and dextrins.
Of these, two (dextrans and dextrose) come from gluten-free grains. (The Member’s question referred to concern about dextrose, but dextrose should be fine.)
The other two (dextrates and dextrins) can come from any source.
Step 3: Lastly, check for the presence of any of the following ingredients that may contain gluten (Cruz et al., 2015):
– Pregelatinized starch
– Sodium starch glycolate
– Caramel coloring
1. If starch, dextrate, or dextrin are not listed in the Product Information, there is probably no problem. If needed, of course, the manufacturer can be contacted.
2. If starch, dextrate, or dextrin are listed, we need more information about the source of these ingredients.
3. If the source is listed as corn, rice, potato, or tapioca, it is gluten-free.
4. If the source is not listed, it has to be looked up in a database or the manufacturer has to be contacted.
Drug and Therapeutics Bulletin. Medicines, excipients, and dietary intolerances. BMJ. 2017 Aug 21;358:j3468. PubMed PMID:28827390.
Cruz JE, Cocchio C, Lai PT, Hermes-DeSantis E. Gluten content of medications. Am J Health Syst Pharm. 2015 Jan 1;72(1):54-60. PubMed PMID: 25511839.
King AR; University of Kansas Drug Information Center Experiential Rotation Students, August 2012. Gluten Content of the Top 200 Medications: Follow-Up to the Influence of Gluten on a Patient’s Medication Choices. Hosp Pharm. 2013 Oct;48(9):736-43. PubMed PMID: 24421547; PubMed Central PMCID: PMC3857120.
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Rubal-Peace G, Sepp C. Addressing Barriers for Patients with Celiac Disease When Assessing for Gluten in Medications. J Acad Nutr Diet. 2018 Jun 5. pii: S2212-2672(18)30477-5. [Epub ahead of print] PubMed PMID: 29884481.
Shah AV, Serajuddin ATM, Mangione RA. Making All Medications Gluten Free. J Pharm Sci. 2018 May;107(5):1263-1268. PubMed PMID: 29287928.
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