If you think determining the gluten-free status of food is difficult, try doing it with prescription medications! It's difficult at best to determine it by reading the ingredient label, and getting a pharmaceutical company to say if their product is gluten-free is like pulling teeth. Ugh...
The Food Allergen Labeling Consumer Protection Act of 2004 [FALCPA] requires packaged food items to declare wheat and other allergens, but medications do not fall under the umbrella of the FDA's rulings.
Medications contain the active ingredient, but generally it needs to combined with something else - something called an excipient.
What's an excipient?
It's a pharmacological term used for an inert substance that acts as a carrier for the actual drug itself [the "active ingredient"]. Excipients are also used as a filler to bulk up formulations to ensure proper and accurate dosages and as a binder [pill form].
For an extensive list of excipients, see glutenfreedrugs.com Excipients List; complete with descriptions.
Drugs.com has an excellent Inactive Ingredients page. Does not address gluten, but very in-depth explanations of each item.
Starches found in medications can include:
- Corn (most common)
- Caramel Coloring*
- Modified Starch*
- Pre-gelatinized Modified Starch*
- Pre-gelatinized Starch*
- Sodium Starch Glycolate*
Since drug companies don't have to disclose source of the starch, there is no easy way to tell if certain ingredients are gluten-free. Calling the manufacturer is the only [and best] option.
Common gluten-free excipients include*:
- Alginic acid
- Alpha tocopheral
- Ascorbic acid
- Benzyl alcohol
- Calcium carbonate
- Citric acid
- Corn starch
- Croscarmellose sodium
- Docusate sodium
- Hydrogenated vegetable oil
- Hydroxypropyl cellulose
- Magnesium carbonate
- Magnesium stearate
- Microcrystalline cellulose
- Propylene glycol
- Silicon dioxide
- Sodium benzoate
- Sodium lauryl sulfate
- Stearic acid
- Xanthan gum
- Zinc stearate
Cynthia Kupper, RD (Executive Director of the Gluten Intolerance Group) states that patches, inhalants, injectables, and liquids/elixirs are not problematic for those following a gluten-free diet. Source: HealthNow's 2010 Gluten Forum DVD
Contained in GIG’s Medications and the Gluten-Free Diet PDF, is a larger version of this pharmacist-created flowchart to aid in the determination of a gluten-free medication.
Here are a few other links of interest:
As with all gluten-free lists - they should only be used as a guide - a starting point. Please verify the status of these products before you take them as ingredients can change.
A companion piece is this great webinar with Steve Plogsted recorded on February 11th, 2015:
Download the slides from that webinar - another excellent resource!
"Abstract: Celiac disease is a chronic condition involving an abnormal immune response to the ingestion of gluten-containing foods and products that commonly results in digestive symptoms, although other organ systems may be involved. The current mainstay of therapy is the avoidance of gluten-containing foods, beverages, and other products. However, if not equipped with the knowledge that medications, OTC products, supplements, and vitamins may contain gluten, patients with celiac disease may experience ongoing symptoms from continued ingestion of these products. Therefore, pharmacists play an essential role in educating patients and evaluating their medication use to ensure the optimal management of celiac disease."
Note: Due to the article's age, any brand name products that are stated as gluten-free, should no longer be considered GF. It's my opinion that any published list of gluten-free products, should not be blindly followed. Since manufacturers can change the ingredient list without notice, the product needs to be verified with each purchase.
Once a pill has been identified, additional information is provided, including brand/generic name, ingredients, and the National Drug File identification number.
Sadly, NFCA no longer offers a free online continuing education program for Pharmacists. However, a handout from the program is still available: Celiac Disease Training for Pharmacists. Still worth sharing with your pharmacist.
They also have a PDF for Pharmacists.
HR 2003: Gluten in Medicine Disclosure Act Update - November 2013:
NFCA interviews Nita Lowey about the Gluten in Medicine Disclosure Act - Read More...
Please, Click here to tell your Representative that we need better labeling on our medications!
Follow this bill's progress via GOVTrack.us.
The Gluten in Medicine Disclosure Act has been endorsed by: American Celiac Disease Alliance, National Foundation for Celiac Awareness, Celiac Disease Foundation, Celiac Sprue Association, Gluten Intolerance Group, North American Society for Pediatric Gastroenterology, Hepatology and Nutrition, and the American College of Gastroenterology.
Suzy's DearPharmacist.com website contains a couple of links worth checking out.
Hopefully you and your Pharmacist find this info helpful.
update 01/12/18 - updated excipient list and note updated GIG’s Medication and the Gluten-Free Diet info
update 09/02/18 - fix broken GIG Medications and Celiac Disease link.
update 01/20/18 - added FDA's Draft guidance document on GF drug labeling.
update 10/19/16 - added AllergicLiving.com's link
update 10/31/15 - Updated GIG's Celiac Disease & Medications link
update 09/12/15 - Added Living Without's - Gluten-Free and More article "Gluten in the Pharmacy"
update 05/13/15 - Added Living Without's - Gluten-Free and More article "Allergens in your Medication"
update 02/23/15 - Added Medscape article "Medications and Supplement Use in Celiac Disease"
update 02/13/15 - Added med research sites and Gluten in Medication Webinar/slides
update 07/29/14 - Added CDF link
update 05/25/14 - Added About.com article.
update 05/25/14 - Added PracticalGastro 2008 & 2009 articles.
update 05/25/14 - Added Delight Gluten-Free Magazine article.
update 03/18/14 - remove link to GREAT Pharmacists training - add link to corresponding PDF
update: 12/14/13 - updated link to GIG's Medications & Celiac Disease educational bulletin
update: 11/9/13 - added Gluten In Medicine Disclosure Act info
update: 9/11/13 - added Living Without's Steven Plogsted interview
update: 05/03/13 - added more info on excipients.