Celiac Disease and Drug Labeling

It has been nine months since I was diagnosed with celiac disease (CD). The only treatment for CD is strict avoidance of gluten. The transition to a gluten-free lifestyle has been a challenge. Leaving behind the food, and sometimes the beauty products, that you love is unpleasant at best. Another significant challenge is mastering the art of label reading.

Food labels can be difficult to understand, and cosmetics and cleaning supplies are more even more challenging – but the most challenging and complicated, by far, are drug labels. Ingestion of gluten from any of these sources can cause some patients with CD to have reactions and become symptomatic.

Last month I came down with my biannual upper respiratory infection. It happens the same way every time. Usually, all I need is a course of antibiotics (or at least I think I need them) and some Mucinex. The old days, before celiac, I would run to the doctor for a Z-Pak or Cipro and then to the pharmacy for some Mucinex. In a few days I would be healthy. Not anymore. Now, I have to figure out if the drugs I am prescribed and buy are safe for me to take – are they gluten-free.

Many over-the-counter (OTC) and prescription medications contain gluten. Gluten is used as an excipient in medications. Excipients are inactive ingredients that form the vehicle for delivery of the active ingredient. The most common gluten-containing excipient or inactive ingredient used is starch. Starch can be derived from corn, wheat, potato, or tapioca. Additional ingredients that may be derived from gluten include, but are not limited to, wheat, modified starch, pregelatinized starch, dextrates, dextrimaltose, caramel coloring, and dextrin. In patients with CD a medication using a wheat-derived excipient can trigger an autoimmune response and the symptoms that accompany it, such as diarrhea, abdominal pain, depression, joint pain, or skin rashes.

How do you tell if a medication is gluten-free?

The Food Allergen Labeling Consumer Protection Act of 2004, which requires that a product containing wheat must list the word “wheat” on the label, does not require that over-the-counter and prescription medications identify wheat or gluten containing ingredients in medications. 21 U.S.C. § 321(qq) (2012).

Under the Food, Drug and Cosmetic Act, OTC medications must list the inactive ingredients in the drug on the “Drug Facts” panel on the medication’s container. 21 C.F.R. §§ 201.66(c)(8) (2012).

Prescription drugs must include a description of the drug, including the inactive ingredients, in the drug’s package insert. Package inserts are part of the labeling for prescription drugs written for the benefit of practitioners.  21 C.F.R. §§ 201.56, 201.57, 201.100 (2012).

Since inactive ingredients must be included on labeling for both OTC and prescription drugs then patients should be able to determine from the label whether the drug contains gluten. Not true.

The inactive ingredients on both OTC and prescription drugs are often listed in a way that makes it impossible to tell if the product contains gluten. In the case of starch the label or package insert may only say “starch” or “pregelatinized starch.” If this is the case then the patient has to take additional precautions for taking the drug.

In the case of prescription drugs the patients’ sources of information is the package insert, the pharmacist, or a call to the manufacturer. Patients are given package inserts under limited circumstances, so a patient cannot count on receiving that information automatically. To access a package insert the patient can conduct a search for it at DailyMed using the drug name. The patient can also ask the pharmacist to provide the package insert or read it for him or her. If the ingredients listed show an excipient that can is or can be derived from a gluten source then the patient must call the manufacturer to confirm the source of the ingredient. Of course, this needs to be done before the pharmacist fills your prescription so you don’t pay for medication you can’t ultimately use. So, practically, this requires an additional visit to the pharmacy and a delay in filling the prescription.

It is important to know that manufacturers change excipients often and excipients vary between brand and generic drugs. Further, pharmacies do not stock the same generic medications from the same manufacturer. A pharmacy may change manufacturers regularly to get the best prices. Therefore, it is not enough to check on a drug’s status just once; you have to check and recheck to ensure you are safe.

As I prepared to tackle my upper respiratory infection I went to my usual OTC weapon, Mucinex. I read the label. The ingredient list for Mucinex includes the word “starch” with no qualifier (“starch(corn)”) Many will say that Mucinex is okay for people with CD because it is on the list of safe drugs on www.glutenfreedrugs.com. This is a handy website and I use as a place to start. However, despite the good intentions of the unnamed pharmacist author of the website, the site neither describes the methods used for compiling its gluten-free list nor the process for maintaining the list. For these reasons, I do my own research.

I went to the Mucinex website to investigate. There is no frequently asked questions list addressing gluten or offering a gluten-free statement. I then followed the site’s instructions and completed the online form for questions where I asked whether Mucinex contains gluten. Notice I did not limit my inquiry to just the starch – gluten can hide elsewhere and it’s good to be general because the response will be technical. Count on it.

A day or so later I received the following:

Dear Ms. Caudill,

Thank you for your email regarding Mucinex®.

In response to your inquiry, while Mucinex® products are not formulated with any ingredients that contain gluten, we have not certified that these products are gluten-free.  The starch ingredient is derived from potatoes.

We appreciate your interest in our product and we regret that we could not be more helpful.

Sincerely, Consumer Relations

This email was friendly, but it does not leave me feeling 100% confident that this medication is gluten-free. Did it even answer my question? The product is “not formulated with any ingredients that contain gluten” and “[t]he starch ingredient is derived from potatoes.” – okay, but does the drug contain gluten? They really won’t say for certain. Is the facility gluten-free? Should I worry about cross contamination? There is no way to know those things from this response.

In most cases, the response from Mucinex is representative of the type of answer you will get from a manufacturer, whether asking about an OTC or prescription drug. If a company does not specifically test for gluten it is highly unlikely that they will state without qualification that a product is gluten-free. They will often remind you that they cannot guarantee that the raw materials that they purchased to make the drug have not suffered cross-contamination. I don’t blame them – saying those things increases their liability.

Mucinex is not the problem. It is a good product. The problem is a lack of laws and regulations requiring prescription and OTC drug labeling to clearly disclose the presence of gluten contained in the drug’s inactive ingredients.

If regulations existed to require manufacturers to clearly list the inactive ingredients on product labels then patients would be better equipped to make choices in the drug store aisle without a day or more delay. Currently, making decisions in the drug store aisle is impossible. To be certain a drug does not contain gluten patients with CD, non-celiac gluten sensitivities (NCGS), or wheat allergies must make multiple phone calls, perform internet searches, and/or have the pharmacist review the package insert with them. At least most of us are able to do those things.

What about the patients with limited education or resources? We wrongly assume that all patients have internet access and are literate. Can everyone access DailyMed and read a package insert (which is written for practitioners), find manufacturer’s contact information, or be confident enough to ask a very busy pharmacist to stop what she is doing and help? Where a patient may not be able or empowered to do those things, most would be able to identify the words “gluten-free” on a drug label.

Assuming that the patient can access the manufacturer or pharmacist, even then, the patient can’t be 100% certain that the drug has not come in contact with gluten in the manufacturing process. There are no regulations that establish what it means for a drug to be gluten-free or to address gluten cross-contamination issues in drug manufacturing.

Part of this problem would be solved if drug labeling laws required that drug labels clearly identify the presence of gluten in a product. The second problem of what it means for a drug to be gluten-free would be solved if the FDA established a gluten threshold for drugs in the United States much like the regulations establishing gluten-free standards for food in the U.S., which are currently awaiting approval by the White House. Establishing such regulations not only benefits patients directly, but it ensures that physicians, pharmacists and other providers are better prepared to treat patients with CD, NCGS, and wheat allergies.

The Food and Drug Administration can make this happen. Let’s ask them to make drugs safe for those with CD, NCGS, and wheat allergies.

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