This post about gluten in medications is for informational purposes and is not intended to replace medical advice from a physician or pharmacist. Please read my disclosures.
While the food industry follows specific guidelines related to how much gluten it can include in a product in order for it to be labeled “gluten-free” (no more than 20 parts per million), the pharmaceutical industry has no such guidelines.
These means a pill meant to help you feel better might be making you sick if you have celiac disease or a gluten sensitivity. It might also mean you’ll forgo taking an important medication altogether in order to avoid potential gluten exposure.
Pillbox is a site published by the National Institute of Health’s National Library of Medicine. It can be somewhat helpful in helping you decode what ingredients are in your medications.
The data provided by Pillbox includes pictures of how pills look, a list of their active and inactive ingredients, along with other criteria that is useful to consumers, doctors and pharmacists alike.
You can search Pillbox using different keywords. I decided to search for “wheat” and “gluten” to see if any medications popped up. Here’s what I found:
- 20 medications contain “wheat”
- 1 medication contains “gluten”
- 11,287 contain “corn”
- 4,263 contain “potato”
- 22 contain “tapioca”
- 14,009 contain “starch”
As you can see, the vast majority of medications do not contain a named gluten ingredient, however, a big chunk of them contain “starch.”
This made me take pause.
A 2019 study published in Science Translational Medicine found that gluten may be found in more medications than we might realize.
In fact, researchers found that 18 percent of drugs contain gluten as an inactive ingredient. This means almost two out of 10 drugs contain gluten.
The report goes on to say that labels rarely say “gluten” or “wheat,” as we found when we researched ingredients on Pillbox; rather most drug manufacturers use the innocuous term, “starch.”
Pillbox found more than 14,000 medications that contain “starch.”
The most common type of starch used (as an inactive ingredient in medications) is corn, however some manufacturers use potato-, tapioca- or wheat-derived starches.
So how in the world do you know if the drug you’re about to take to relieve your symptoms isn’t one of the 18 percent of drugs that contain gluten?
Let’s see what the FDA has to say.
The FDA’s Guidelines on Gluten in Medications
The FDA says that most medications don’t contain any gluten (wheat, rye or barley), and if they do, it’s a very trace amount that the FDA says is “safe” for someone with celiac disease to ingest. The FDA adds that barley and rye are either used “rarely or not at all” in the production of medications.
Specifically, the FDA says, “The amount of gluten potentially present in a unit dose of an oral drug product is less than the amount of gluten that could potentially be found in a single serving of a cookie (30 grams) labeled gluten-free in accordance with FDA’s regulations.”
Based on this information, the FDA concludes, “Individuals who respond well to a gluten-free diet are at low risk of experiencing problems as a result of the possible presence of gluten in a drug product.” This information is all according to an FDA December 2017 report titled, “Gluten in Drug Products and Associated Labeling Recommendations Guidance for Industry.”
All this sounds lovely – but what about the 2019 study that says 18 percent of medications contain gluten? The study’s finding are contradictory to what the FDA says. Confused yet? I know I am!
The FDA is making strides in encouraging the disclosure of gluten in medications (inclusive of oral medications and topical medications applied in or around the mouth), but the agency hasn’t gone far enough to product the celiac and gluten sensitive communities.
At this time, the only guidance the FDA provides to pharmaceuticals is what a voluntary gluten disclosure statement should look like and where it should appear on a product’s package. While the FDA says many pharmaceuticals are listing inactive ingredients on their labels already, it is not mandatory for them to do so, nor are the labels consistent or readily understood.
In the report, the FDA says if a drug manufacturer wants to make statements about gluten on its label, it should use the following language (if truthful): “Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).”
Furthermore, the FDA says the information should be included in the description section of the prescribing information at the end of the inactive ingredients list. It also should be on the container label or on the side or back panel of the carton label.
The FDA says it “encourages” drug manufacturers to have accurate information about their products’ gluten content available in order to respond to questions from consumers and health care professionals. The FDA adds, “Manufacturers should pay attention to possible sources of gluten in their products … and consider the impact of changes in ingredient sources or formulations on gluten content.”
Unfortunately, as mentioned, these guidelines are voluntary and not everything is as cut and dry as we all would like it to be.
For example, someone posted in my Gluten-Free Support Group on Facebook that some Benadryl over-the-counter medications are not gluten-free. I tried to independently verify this information with Johnson & Johnson and got a most disappointing reply saying, “Sadly, we do not have any information on whether our BENADRYL® Allergy Tablets have gluten or not.”
Wait, Johnson and Johnson, a multi-billion dollar company, doesn’t even know what ingredients are in (or not in) in their products?!?!
It would seem as if Johnson and Johnson is thumbing its nose at the FDA’s voluntary “guidelines.”
What’s a Gluten-Free Person to Do?
No doubt, labeling for gluten in the pharmaceutical world has come a long way, but it has an even longer way to go. These baby steps by the FDA are, simply put, baby steps and not enough.
If you need to take an over-the-counter or prescription drug now, do the following to make sure you’re not accidentally exposing yourself to gluten:
(1) Inspect the Label: As discussed, many drug manufacturers are making voluntary allergen disclosures. Look under the “description” and “inactive ingredient” sections. If you see the word “starch,” take pause. If you are suspicious the drug contains gluten, look at the generic version or other brands for a similar drug to see if you can find something more clearly labeled. Speak with your wallet and support brands with clear labels.
(2) Ask the Pharmacist: While most pharmacists are in the dark like us, it’s good to have a conversation with them to see if they might know. Perhaps they can help champion change as well, especially if they’re getting the gluten question over and over again.
(3) Check Pillbox.com: If the ingredients are unclear or not disclosed on the label, search for the name of that drug on Pillbox.com.
(4) Contact the Manufacturer: You may be surprised and actually get a clear-cut answer (which is happening more often as more of us ask!). When I wrote my Is Your Lip Balm Gluten-Free article, I asked companies like Carmex and Blistex if their products contained gluten. I received clear-cut answers.
However, you might also receive a reply like the one Johnson and Johnson sent me, or a wishy-washy reply I get often that says something like, “Our product does not contain gluten ingredients but we cannot guarantee the product is gluten-free.”
The important thing is that we continue to ask these drug manufacturers for this kind of information. The more we ask, the more they will have to answer us (and perhaps it will encourage them to be proactive in labeling so we don’t have to keep asking).
(5) Research Online: The Internet can be a wonderful place for crowdsourcing information, however, not everything you read or see on the Internet is accurate or truthful. Reader beware. It can, however, be helpful to see how others have approached your same situation.
(6) Test It… Maybe Someday: Maybe one day we’ll be able to test our medications before we consume them. The Nima Sensor is a portable gluten detecting device that allows you to test food for gluten. It is not approved for testing of drugs at this time, but maybe someday it will be. I tested a Zyrtec tablet anyway (shhh!).
(7) Live Well: I think the best prescription is living well, eating right, stressing less and being healthy. Of course very few people can avoid medications in their lifetime, but if you live well, you’ll need few, if any, drugs to help you through life.
In the meantime, continue to champion the FDA for mandatory labeling laws and demand more transparency from drug manufacturers.
Keep asking the questions and making noise. Change, it is a coming…