The risk is low. Here’s how to manage it.
You may be extremely diligent about avoiding all sources of gluten—but what about gluten in your prescription and over-the-counter medications? The last place you want to encounter gluten is in a pill that’s supposed to make you well.
The good news is that most medications don’t contain gluten. The bad news is that confirming a medication’s gluten-free status can be extremely challenging.
Unlike food, manufacturers aren’t required to disclose the presence of wheat or gluten on their drug labels. Even a pharmacist might not know if the medication or its generic version contains gluten. A phone call to the manufacturer might leave you frustrated, because many won’t tell you definitively about a drug’s gluten-free status.
In December 2017, the U.S. Food and Drug Administration developed a draft gluten-free labeling guidance, which is still under review, that would encourage—but not require—that manufacturers include a statement that their drug product “contains no ingredient made from a gluten-containing grain (wheat, barley or rye)” when appropriate. However, the guidelines don’t require that manufacturers use the term “gluten-free” and they don’t require testing. The guidelines do not apply to dietary supplements or cosmetics.
The Risk of Gluten
Fortunately, the risk of gluten in medications is small. “The majority of oral drug products either contain no gluten or virtually no gluten,” the FDA says. “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.”
Starch used in medications is usually cornstarch or potato starch. Only a small number of drugs have wheat starch as an ingredient. “Very few, if any” have ingredients derived from barley or rye, the FDA says.
Wheat starch is processed to remove proteins, including gluten. The FDA estimates that wheat starch and other ingredients derived from wheat would contain no more than 0.5 mg of gluten in a dose of an oral drug. The FDA says that the amount of gluten potentially present would be less than that in a gluten-free cookie.
Importance of Labeling
While the draft guidance encourages manufacturers to state whether their medications contain gluten, it doesn’t require it.
Better drug labeling would be helpful to consumers who are diligent about avoiding any source of gluten, says Steve Plogsted, PharmD, clinical pharmacist at Nationwide Children’s Hospital in Columbus, Ohio, and founder of glutenfreedrugs.com. Some consumers are very sensitive to minute amounts of gluten and many want to know beyond a doubt if their medications contain gluten, he says.
Even though most drugs don’t contain gluten, “it’s still a concern because there are varying degrees of sensitivity that the celiac population experiences,” Plogsted says. “Manufacturers could put an easy-to-read statement on the bottle that there are no known wheat-containing ingredients in this medication. They know what they’re putting in there and so it would be a simple thing to do.”
If consumers aren’t assured that a drug is gluten-free, some might skip their medications. “Even if gluten is not present at levels that would harm a typical individual with celiac disease, that individual may be harmed through uncertainty and lack of information,” the FDA recognizes.
When researching the gluten-free status of your medications, look out for these terms.
Wheat Flour: According to Plogsted, wheat flour is not used in oral drugs in the United States and it is not used in processing or in dusting manufacturing lines.
Wheat Starch: A very small number of oral drugs contain wheat starch as an ingredient. The FDA states, “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.” The FDA’s draft guidance suggests that “any oral drug product that contains wheat starch as an intentionally added ingredient should be labeled to indicate its presence.”
Some studies have shown that when wheat starch is used, it contributes less than 0.1 mg gluten to a dose of a drug, according to Plogsted. For context, research has shown that up to 10 mg of gluten per day is unlikely to trigger intestinal damage in those with celiac disease. However, adds Plogsted, people have different sensitivities to gluten. Many with celiac disease want to avoid wheat starch as an ingredient, even if there’s only a small potential for exposure.
Other Sources of Starch: Some consumers may want to avoid all starches in medications, including potato starch, cornstarch and tapioca starch. “If you don’t have starch in there, the chance of gluten contamination goes way, way down,” Plogsted says. “You really want to focus on the word ‘starch.’ Anything else is really not a concern.”
Barley or Rye: Plogsted says he isn’t aware of any drugs containing ingredients derived from barley or rye.
Lactose: While people with a dairy allergy need to avoid all sources of milk, Plogsted says that most people with lactose intolerance are able to tolerate lactose in medications. “If you’re lactose intolerant, you’re not going to react to the lactose volume in a pill. There’s just not enough there.”
Topical or Injectable Drugs: “We really don’t have to worry about topicals, injectables, ear drops or nose drops,” Plogsted says. “They’re never made with wheat or wheat derivatives. There’s no gluten in liquid medications ever.”
Polyols: Sugar alcohols, such as sorbitol, xylitol, maltitol and mannitol, are used as sugar substitutes and do not contain gluten. Even if the original source of the material is wheat, it undergoes so many steps of purification that no protein remains, according to Plogsted and the FDA.
Some manufacturers say that polyols contain gluten, even when they don’t. For instance, “Advil came up with a dissolvable tablet and said it’s coated with gluten, but it’s coated with the sugar substitute mannitol,” Plogsted says. “Even if there were the tiniest amount of gluten protein left in the amount that would be painted on a tablet, you couldn’t even measure it. The company will straight out tell you that it contains gluten just because it has mannitol on it, but they don’t test it.”
Sugar alcohols can cause diarrhea in some people when taken in large volumes, such as in liquid medications, but tablets and capsules don’t have that effect. “If you take too much of any polyols, you’ll get diarrhea. People will swear that they were glutened but it’s just diarrhea from the sorbitol,” Plogsted says.
Hydrolysates: Some ingredients, such as maltodextrin, maltose, dextrose and glucose syrup, can be made from a variety of starches, including cornstarch, potato starch, rice starch or wheat starch. Even if made from wheat starch, these ingredients are gluten-free because their extensive processing removes the harmful gluten protein, Plogsted says.
A First Step
According to Marilyn Geller, CEO of the Celiac Disease Foundation, the FDA’s draft guidelines are “a great start.”
After the FDA issued final labeling guidelines for gluten-free food products in 2013, food manufacturers jumped at the chance to slap a gluten-free label on their products. Geller is optimistic the drug industry will show similar enthusiasm.
“We’re really hopeful that all it will take is for one of the large drug manufacturers to do this and then the others will follow because it will be a competitive advantage,” she says. “Hopefully, these guidelines will help resolve consumer fears. If more needs to be done after they’re implemented, we’ll certainly push for more.”
Be a Medication Detective
Use these tips to help track down drugs that don’t contain gluten or starch.
Check Pillbox & DailyMed.
These free federal websites, maintained by the National Library of Medicine at the National Institutes of Health, contain detailed information about drugs.
Pillbox is a large database of prescription and over-the-counter drug information. Use it to search for specific ingredients. For instance, type “wheat” in the “inactive ingredients” search box and you’ll come up with a handful of rarely used drugs. If you want to find a drug without any starch in it, do an advanced search to look for that medication (for example, an atorvastatin) without starch. Similarly, you can look for drugs without corn, lactose or soy.
DailyMed is the official provider of the FDA’s label information and medication package inserts. You can look up drugs to find their detailed ingredient information, as well as their complete prescribing information.
This trusted website of gluten-free medications was founded by Steve Plogsted, PharmD, clinical pharmacist at Nationwide Children’s Hospital in Columbus, Ohio. He keeps the website current and answers readers’ questions on the site.
Check with your pharmacist.
If you’re concerned that your medication may contain gluten or starch, ask your pharmacist. Brand medications contain certain ingredients that are documented by their manufacturers. In contrast, generics can be produced by different manufacturers and can contain varying inactive ingredients. If you use Pillbox to identify a brand that you prefer, a pharmacist can look on the pharmacy’s wholesaler lists and determine whether that brand or a viable generic is available. Note that some national chain pharmacies might be limited in their options, Plogsted says; they buy in bulk and have national contracts with generic manufacturers.
Eve Becker is associate editor of Gluten Free & More magazine.