According to the National Foundation for Celiac Awareness manufacturers use inactive ingredients to bind pills together. There are several types of inactive ingredients that drug companies may use, and some of them may contain gluten. Although few medications actually contain gluten, it is important that the inactive ingredients of each medication are explored to determine the source – and to verify that the particular drug in question is indeed gluten-free. Complicating matters, a generic form of a medication may use different inactive ingredients than the brand name drug. This means that even if the brand name is determined to be gluten-free, the status of each generic produced by different manufacturers must also be verified.
The following inactive ingredients indicate the need for additional investigation to determine the status of the drug:
• Modified starch (source not specified)
• Pregelatinized starch (source not specified)
• Pregelatinized modified starch (source not specified)
• Dextrates (source not specified)
• Dextrin (source not specified but usually corn or potato)
• Dextrimaltose(when barley malt is used)
• Caramel coloring (when barley malt is used)
The Food Allergen Labeling Consumer Protection Act of 2004, requires packaged food labels to identify all ingredients containing wheat and other common allergens. However, no similar requirement exists for medication labels.
Resources for checking if your medication contains gluten:
1. Contact the company that makes your drugs, or ask your pharmacist to do so.
2. Glutenfreedrugs.com is a website maintained as a public service by a pharmacist at Nationwide Children’s Hospital.
3. A Guide through the Medicine Cabinet is a book developed to provide people with special dietary requirements additional information about medications.
To date the FDA has not defined gluten free, so this area is open for interpretation, some manufacturers are using the threshold of 20 parts per million (ppm) to identify a product as gluten-free.
The gluten free market is expected to reach $5 billion by 2012. With this kind of consumer dollars in play, drug manufacturers will hop on the gluten free bandwagon and promote their products as gluten free. At least one company The Perrigo Company, a leading global healthcare supplier that develops, manufactures and distributes over-the-counter (OTC) and prescription pharmaceuticals, nutritional products, active pharmaceutical ingredients (API) and consumer products, has taken the initiative to institute a “gluten-free assurance program”.
While pharmacists are your first-line resource for determining if a drug contains gluten, the surest way is to call the manufacturer directly.