Better living thru Gluten-Free Chemistry

Updated 05/13/2015

In January I had to re-enter the world of pharmaceuticals [much to my displeasure, but best for my long term health]. 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*
Dextrates*
Dextrin*
Dextrimaltose*

Maltodextrin*
Modified Starch*
Potato
Pregelatinized Starch*
Pregelatinized Modified Starch*
Sodium Starch Glycolate*
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 PDF

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


Mylan Labs

So far, Mylan Labs has the best response about GF status of several pharmaceutical companies.

I was doing a status check on a medication and had an interesting talk with a Mylan [a drug mfg] customer service rep. He was very knowledgeable and understanding. He was a nurse, so he had a clue about celiac disease. He even mentioned gluten sensitivity.

They have a manufacturing facility in Morgantown, WV where 80-90% of their meds are made. The rep I spoke with last was based in WV. The rep I spoke with earlier, was not from location, probably PA. They do outsource some meds to a facility in India.

I was told that no wheat, barley, rye, spelt or oats are used in that facility in Morgantown. I was told by the rep in PA 3 months ago, that the "no gluten" was no longer the case. I will still continue to verify that info every 3 months at refill.

I asked raw ingredients were tested for gluten...he said ingredients were tested for quality and purity, but did not specifically say gluten. He did mention that they did test one of their meds [I can't remember which one], and it tested as gluten-free.

When calling Mylan, try to speak with someone in the Morgantown, WV plant. They will need the name of medication, the dosage, and the markings on the medication. If tablet - they'll ask about both sides



Here are a few other links of interest:



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.



Older article, but still has useful information



Older article, but still has useful information



A lot of good information in this interview with Steve Plogsted, PharmD, BCNSP, CNSC.



More info about gluten in medication. Another interview with Steve Plogsted, PharmD, BCNSP, CNSC.



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.



4 tips to make your medications safer.



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 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.



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/



Reps Tim Ryan (OH) and Nita Lowey (NY) have introduced the Gluten in Medicine Disclosure Act (HR 2003). This bill requires the sources of gluten to be listed on medication labels.

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 Cohen participated in Dr. Tom O'Bryan's Gluten Summit: A Grain of Truth. Her topic was "Hidden Sources of Gluten in Your Vitamins and Medications". She offered a lot of great information about navigating the world of medications. If you missed the free airing of these interviews, you can purchase access to all 29 amazing interviews.

Suzy's
DearPharmacist.com website contains a couple of links worth checking out.





Hopefully you and your Pharmacist find this info helpful.

Al

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.