FacebookCeliac disease affects roughly 1 in 133 Americans and another 18 million people in the United States suffer from gluten sensitivities. In either case, the most effective treatment is eliminating gluten from the diet. Fortunately, gluten free food products have become readily available and new gluten free and allergen-friendly brands are popping up all the time.
While it may be fairly simple to identify gluten in food products – especially those that contain wheat, barley, or rye – other products like medications and supplements can be tricky. Food products regulated by the FDA must carry an allergen warning, but the FDA doesn’t require drug companies to list gluten as an allergen if it comes from an inactive ingredient like starch.
Here’s what you need to know about gluten in medications and supplements.
How Common is Gluten in Medications?
Medications, both over-the-counter and prescription, are made up of a long list of ingredients. The ingredients in medication are known as excipients and they include the active components as well as the protectants, binders, absorbents, coloring agents, bulking agents, and lubricators in the product. The FDA deems these excipients inactive and therefore safe for human use, but they can still trigger unwanted reactions. Though it may be rare, medications and supplements can contain traces of gluten.
The most common excipient used in medication is starch, generally from corn, potato, tapioca, or wheat. A thorough search of the National Library of Medicine database revealed over 8,300 individual products that contained the word “starch.” Corn was the most common form of starch used in medications, yielding over 6,500 results while wheat starch was the least common with 11 records.
What Ingredients are Most Likely to Contain Gluten?
Drug companies have a lot of leeway when it comes to disclosing ingredients and formulas. There is currently no law requiring drug manufacturers to disclose the source of excipients used in their products, so it’s difficult for the average person to obtain this information. While some companies are very forthcoming with this kind of data, others are not.
Even if you can get a drug company to confirm that they don’t use any gluten in the manufacturing of their products, few will guarantee any of their products are gluten-free.
Not only is starch the most common excipient used in medication, but it’s very unlikely that any excipient other than starch will contain a measurable amount of gluten. The tricky thing is that drug companies aren’t required to disclose what form of starch is used in their products. The word “starch” can refer to any starch, unlike the food industry where the generic “starch” must come from corn.
In rare cases, you may come across a medication that uses wheat starch in which case you have two options. Your first option is to look for an alternative product and your second option is to do a little digging to get more information. You can contact the manufacturer and ask whether they use gluten in their products and, if so, ask them to disclose the source of gluten. If the source is wheat starch, you should avoid the product but, if it the company says it is “derived from a wheat source” it may be derived from one of the sugar alcohols in wheat which don’t contain gluten.
The Risk of Cross Contamination
Even if a drug manufacturer doesn’t use gluten in their products, few are willing to guarantee their products are completely gluten-free due to the potential for cross-contamination. While cross-contamination is always a possibility, it’s very unlikely in the case of medications versus food. Drug manufacturing plants must adhere to strict FDA requirements for air quality control which limits the risk of cross-contamination.
What About Vitamins and Supplements?
The FDA considers dietary supplements different from medications because they are not intended to treat, diagnose, mitigate, prevent, or cure a disease. While the FDA oversees the manufacture of both medications and supplements, the regulations are different. Medications, both prescription and over-the-counter, must be approved by the FDA before they can be marketed or sold but supplements do not. Supplement companies are only required to have evidence of their product’s safety and they must make truthful claims on the packaging.
Because supplements are less regulated, and because they contain different active and inactive ingredients, there is a slightly higher risk that they may contain gluten than most medications. Fortunately, supplements are required to list their ingredients on the packaging, so you should be able to determine whether a product is safe fairly easily.
Whether you have celiac disease, a wheat allergy, or a gluten sensitivity, it’s important to exercise caution when taking medication and supplements. If you can’t find the information you need on to make an educated decision on the label, try one of these resources:
- Gluten in Medications Guide – Created in collaboration with the American Society of Health-System Pharmacists (ASHP), this guide provides helpful tips for identifying gluten in medications and common starches used in the manufacture of drugs.
- The Rubins – A website dedicated to senior citizens, this resource provides a directory of drug manufacturers including web addresses and phone numbers.
- Gluten-Free Drug List – Maintained by Dr. Steven Plogsted and pharmacy students at Columbus Children’s Hospital in Columbus, OH, this database of gluten-free drugs was updated in March of 2020. View the drug list in alphabetical order or download the printable PDF.
As you perform your own research, remember that many prescription drugs come in a generic form which may have a different formula than the brand-name drug. Drug manufacturers can also change their formulations at any time without warning, so it doesn’t hurt to double-check from time to time.
