Excipient

Better living thru Gluten-Free Chemistry

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Updated 01/12/2021

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)
  • Cyclodextrins*
  • Dextrates*
  • Dextrin*
  • Dextrimaltose*
  • Maltodextrin*
  • Modified Starch*
  • Pre-gelatinized Modified Starch*
  • Pre-gelatinized Starch*
  • Sodium Starch Glycolate*
  • Starch*
  • Tapioca
  • Wheat
*These items need further investigation if the source of the starch is not specified. The ingredient in question could be derived from either a glutenous or non-glutenous plant source.


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*:
  • Acacia
  • Alginic acid
  • Alpha tocopheral
  • Ascorbic acid
  • Benzyl alcohol
  • Calcium carbonate
  • Carboxymethylcellulose
  • Citric acid
  • Corn starch
  • Croscarmellose sodium
  • Dextrose
  • Docusate sodium
  • Fructose
  • Glucose
  • Hydrogenated vegetable oil
  • Hydroxypropyl cellulose
  • Lactose
  • Magnesium carbonate
  • Magnesium stearate
  • Matitol
  • Maltose
  • Mannitol
  • Microcrystalline cellulose
  • Polydextrose
  • Povidone
  • Propylene glycol
  • Silicon dioxide
  • Simethicone
  • Sodium benzoate
  • Sodium lauryl sulfate
  • Sorbitol
  • Stearic acid
  • Sucrose
  • Vanillin
  • Xanthan gum
  • Zinc stearate
*Source: The Gluten Intolerance Group Medications & Celiac Disease (updated January 2019)

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.

GIG GF status of Meds



Here are a few other links of interest:


”On April 8, 2021, Representative Tim Ryan (D-Ohio) introduced bill H.R.2435 “to amend the Federal Food, Drug, and Cosmetic Act to require the label of a drug that is intended for human use and contains an ingredient that is derived directly or indirectly from a gluten-containing grain to identify each such ingredient, and for other purposes.”

"In the meantime, remember that the FDA has stated they know of no oral drug products currently in the marketplace that contain wheat gluten or wheat flour as an ingredient. The agency has identified a few oral medications that contain wheat starch as an ingredient. (Oral drug products do not typically contain barley or rye). For more information see https://www.fda.gov/drugs/ensuring-safe-use-medicine/medications-and-gluten"

"It is also important to remember that when wheat starch is used in a medication it is likely to be used in small amounts and contribute very little residual gluten protein to the final product. This is because wheat starch contains only small amounts of residual protein and the weight amount of most medication dosages is low. As a result, the amount of gluten ingested is low. For example if a medication contains 20 ppm of gluten, you would have to ingest one ounce of medication (this is a lot) to take in about ½ milligram of gluten (10 mg of gluten per day is considered a “safe” amount by most experts). What does an ounce of medication look like? Here is one example:"




”Congressmen Tim Ryan and Steve Stivers plan to re-introduce the Gluten in Medicine Disclosure Act for the 117th Congress on Thursday, April 8, 2021.

If passed, the bill would amend the Federal Food, Drug, and Cosmetic Act to require gluten to be labeled in all medications.

The Act

The act is titled H.R.2435 – To amend the Federal Food, Drug, and Cosmetic Act to require the label of a drug that is intended for human use and contains an ingredient that is derived directly or indirectly from a gluten-containing grain to identify each such ingredient, and for other purposes. What Will This Act Do?

Will make it easier to identify gluten in prescription drugs.

It would require drug manufacturers to label medications intended for human use with the list of ingredients, their source, and whether gluten is present.

A gluten-containing drug that does not meet these requirements would be considered misbranded under Section 502 of the Federal Food, Drug, and Cosmetic Act.

This labeling will allow concerned consumers to know, for example, if the starch in their prescription drugs comes from wheat or corn; that small distinction is an important one."




Gluten and Generic Medication - PsychCentral.com - George Hofmann - December 13, 2019

”Pills, tablets and capsules, contain excipients that include the active ingredient and several other ingredients that help bind the drug together and aid with metabolism and absorption so that the active ingredient is properly delivered to the body."

"One of the most common excipients is starch, and sometimes that starch is derived from wheat. While not common, the appearance of wheat, gluten, in a drug poses a real problem for people with celiac disease or gluten intolerance."

"Celiac and bipolar disorder may be co-morbid, and gluten may play a role in manic episodes, so people with bipolar disorder should be vigilant about what excipients appear in their medicine."

"It’s very rare for a brand name medicine to contain gluten. However, generic drugs often don’t contain the same excipients as the brand name drugs they copy. Only the active ingredient is required to be the same."

"What’s a person with celiac or gluten intolerance to do? Take your meds. If symptoms caused by gluten do appear, don’t stop taking what your doctor prescribed. That could lead to more trouble than gluten reactions."

"Check the database for allergens, and talk to your pharmacist. Most generics, including popular psych meds, are manufactured by more than one company. If you don’t tolerate one, an equivalent drug from another manufacturer can be obtained."

Sadly, this article no longer exists




”The bill intends to make it easier to identify gluten in prescription medications by requiring drug manufacturers to label medications with the list of ingredients, their source, and whether gluten is present.

The Celiac Disease Foundation has been working with Representative Ryan's staff since 2012 on the need for labeling of gluten in medication and is proud to endorse this bill. The Gluten in Medicine Disclosure Act of 2019 was introduced in the House of Representatives and referred to the House Committee on Energy and Commerce. If passed by the House, the bill will move forward for review by the Senate.

Read the full text of the Gluten in Medicine Disclosure Act of 2019" :
http://bit.ly/2Gdi1qZ

Bills like this have been submitted since 2013, but they never saw the light of day. Please contact your senators and congressional representatives to let them know this bill is important to you.

Find your Senators and Congressional Representatives.



”This guidance is intended to convey to drug manufacturers FDA's recommendations on how 17 certain drug products should be labeled regarding gluten, a matter of interest to individuals with 18 celiac disease. Some individuals with celiac disease have faced difficulty when trying to 19 determine whether specific drug products contain gluten. Confronted by uncertainty, some 20 patients may forego important medication rather than risk an adverse reaction to gluten. Thus, 21 even if gluten is not present at levels that would harm a typical individual with celiac disease, 22 that individual may be harmed through uncertainty and lack of information.”



A good resource to start your GF meds search is http://glutenfreedrugs.com/ This site is maintained by Steve Plogsted, PharmD, BCNSP, CNSC and his pharmacy students at Columbus Children's Hospital, Columbus, OH.

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 lot of great information about medications and gluten.

A companion piece is this great webinar with Steve Plogsted recorded on February 11th, 2015: https://www.youtube.com/watch?v=DwZvYPhfGZg

Download the slides from that webinar - another excellent resource!


Medication and Supplement Use in Celiac Disease - Medscape (requires a free account)

Ashley N. Johnson, PharmD, BCPS, Angela N. Skaff, BS, PharmD Candidate, Lauren Senesac, PharmD Candidate. US Pharmacist. 2014;39(12):44-48

“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.”



This is a great article, despite it's age [Jan. 2007]. If you are gluten-free and take medications, please take the time to read this article and educate yourself. Pharmacists also need to be educated about gluten-free medication as well. It has been my experience that GF knowledge is hit and miss [at least in my home town]. I printed this article and gave it to my pharmacist.

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.



Great article by Lisa Fitterman about gluten in medication.



Great article by Erica Dermer. Can your pharmacist tell you whether there's gluten in your prescriptions?



4 tips to make your medications safer.



Hints and tips from Nancy Lipid.



DailyMed provides high quality information about marketed drugs. This information includes FDA labels (package inserts) and ingredient lists. This Web site provides health information providers and the public with a standard, comprehensive, up-to-date, look-up and download resource of medication content and labeling as found in medication package inserts. The National Library of Medicine (NLM) provides this as a public service and does not accept advertisements.



Pillbox – Provides a way to search medications by ingredient. The Pillbox website was developed to aid in the identification of unknown pills (oral solid dosage form medications). It combines images of pills with appearance and other information to enable users to visually search for and identify oral solid dosage form medications.

Once a pill has been identified, additional information is provided, including brand/generic name, ingredients, and the National Drug File identification number.



NFCA presents some basic background information on celiac disease and areas where gluten might hide in medications.

Sadly, NFCA no longer offers a free online continuing education program for Pharmacists. However, a PDF is still available: PDF for Pharmacists.



Background info on Gluten in Medicine Disclosure Act (HR 2003)

HR 2003: Gluten in Medicine Disclosure Act Update - November 2013:
http://celiac.org/blog/2013/11/06/hr-2003-gluten-in-medicine-disclosure-act-update/




Hopefully you and your Pharmacist find this info helpful.

Al

update 04/29/21 - Add Gluten in Medications Act info.
update 01/12/21 - Update GIG links and graphics. Update links.
update 12/14/19 - Added Gluten and Generic Medications Article
update 04/09/19 - Added CDF Gluten in Medication Disclosure Act of 2019 info.
update 01/12/19 - 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.