Make Your Voice Heard!
Letter to the FDA Regarding Medication Labeling
The FDA released draft guidelines for labeling gluten in medications. While the efforts are a start, the action is not enough. The FDA is accepting comments about the guidelines until February 12, 2018.
Click here to make your voice heard!
**You can copy and paste this message into the FDA's website
Docket Number: 2017-26828
Gluten in Drug Products and Associated Labeling Recommendations
Guidance for Industry
US Department of Health and Human Services
Food and Drug Administration
As someone who must follow a medically prescribed gluten-free diet, being able to identify that a drug is gluten-free is critical to my health. For me, even a minute amount of gluten in a drug can cause debilitating symptoms and/or intestinal damage with long-term complications.
While I am glad the FDA has issued draft guidance for labeling of gluten in medications, the proposal falls far short of meeting my needs.
The fact that labeling of gluten from wheat, barely and rye would be voluntary dilutes the good it is intended to do. Although medications often don’t contain gluten, the uncertainty created by the unknown few that do cannot be erased.
As long as gluten is not clearly labeled, I will continue to worry about whether a medication I am taking to treat a condition or illness is compromising the gluten-free diet that currently is the only treatment for celiac disease and other gluten-related disorders.
Drug companies are often uncooperative when it comes to giving gluten-free consumers accurate information about the gluten-free status of their products. The completely voluntary nature of this draft guidance does nothing to change that.
I join with others in the celiac disease and gluten sensitive communities in asking for meaningful change in the form of mandatory labeling of gluten from wheat, barley and rye when it is contained in a drug. Additionally, the FDA should allow voluntary use of a gluten-free label when a medication meets the standard established for food, less than 20 parts per million, including gluten from processing or cross-contact.
All labeling information should be directly accessible by consumers. That way, if my pharmacist changes the brand or generic version of a drug that I take, I would instantly know if it is safe on my gluten-free diet.
Those who have celiac disease, a serious autoimmune condition, and other gluten-related disorders should be able to eat without fear. And, we have a right to take medications without fear, as well.
I want to thank the FDA for recognizing this need and beginning the work to address it.
Gluten in medications is a hot topic within the celiac disease community. After all, how can you successfully manage celiac disease if medications you need contain gluten?
Gluten-free claims on packaged foods and supplements are regulated by the US Food and Drug Administration (FDA) and standards are in place requiring manufacturers to call out certain common allergens if they are included in a packaged food. Unfortunately, similar laws are not in place for labeling gluten in medications, although a proposed bill was reintroduced to Congress in September 2015.
There are risks for the celiac disease community when gluten is left off a medication label:
- Manufacturers use excipients, which bind pills together and help deliver the medication to the patient. There are several types of excipients, and some of them may contain gluten.
- Few medications actually contain gluten, but it is important that the ingredients of each medication are explored to find the source of excipients – and to verify the particular drug is gluten-free.
- The generic form of a medication may use different excipients than the brand name drug. Even if the brand name is determined to be gluten-free, the gluten-free status of each generic must be verified.
Frequently Asked Questions about Gluten in Medications
Q: How likely is it that a prescription or over the counter drug has gluten in its inactive ingredients?
A: Few medications contain gluten, but every oral medication must be checked to make sure it is gluten-free, since current labeling regulations do not require gluten to be labeled in medications. It is important to remember that generic and brand name products containing the same active drug may contain different inactive ingredients. The source of these ingredients can be changed at any time without notice from the manufacturer. It also should be verified that the manufacturer has taken proper steps to avoid cross-contact from gluten-containing products.
The following inactive ingredients are considered “red flags,” as they may be sourced from wheat, barley or rye. The presence of red-flag ingredients indicates that there is a need for additional investigation to determine if the drug’s ingredients were derived from gluten:
- Modified starch (if source is not specified)
- Pregelatinized starch (if source is not specified)
- Pregelatinized modified starch (if source is not specified)
- Dextrates (if source is not specified)
- Dextrin (if source is not specified; the source is usually corn or potato which is acceptable)
- Dextrimaltose (when barley malt is used)
- Caramel coloring (when barley malt is used)
Q: What should I do if I think I’m getting glutened by my medicine?
A: Your first step should be to call your physician to let them know that you’re experiencing symptoms. Do not stop taking prescription medicine without talking to your doctor first. There may be reasons aside from gluten exposure that you are experiencing symptoms, such as side effects of the prescribed medication. It is important to understand that some common side effects of medicines overlap with gluten exposure. Similarly, sugar alcohols in medications can cause significant stomach discomfort that could be easily confused with symptoms of gluten exposure. Beyond Celiac strongly recommends that you share your concerns and any symptoms with your doctor as soon as possible. Call the manufacturer to ask about the sources of their inactive ingredients as well as their production processes and any steps taken to prevent gluten exposure.
Q: Who can I contact to report a suspected reaction to gluten in medication?
A: It is important to look into medications to find out if they contain gluten before taking the medication. However, if you think you are having a reaction to gluten in your medication, Beyond Celiac strongly suggests that you contact your doctor, explain your reaction, and call the manufacturer of the medication in question to alert them to the issue. Your pharmacist might also be able to help you figure out if your medication contains gluten. When talking to the manufacturer, you should also ask them:
- What their production processes are
- If their medications are made on shared equipment with gluten-containing medications
- Whether they test their products for gluten
- If they speak to the manufacturers of their sourced ingredients about possible gluten in their raw materials.
Q: What types of medications are covered under the FDA’s gluten-free labeling rule?
A: While prescriptions and over-the-counter medications are not covered under the FDA’s gluten-free labeling rule, dietary supplements, such as vitamins and minerals, are covered, and must contain less than 20 parts per million (ppm) gluten if they are labeled gluten-free.
Q: How should I talk about my gluten-free needs with my pharmacist?
A: It is important to be as thorough and clear as possible when talking about your gluten-free needs with your pharmacist. You should tell them that you are on a gluten-free diet to treat celiac disease, a serious genetic autoimmune disease. It may be helpful to tell them that you are at risk for serious health consequences, like thyroid disease, infertility, osteoporosis and even certain cancers if you continuously ingest gluten. You should also make sure to discuss hidden sources of gluten (listed above) and highlight the risks of cross-contact. Explain cross-contact to your pharmacist to help them understand the different ways you can be exposed to gluten.
Q: What resources can I use to find safe medications?*
A: Below are some recommended resources for identifying safe and unsafe medications*:
- Gluten in Medications Guide: This guide, created and developed in collaboration with American Society of Health-System Pharmacists (ASHP), can help when asking pharmacists about gluten-free prescriptions and other medication needs.
- Gluten-Free Drugs: This list is maintained by Dr. Steven Plogsted and his pharmacy students at Columbus Children’s Hospital, Columbus, OH.
- The Rubins: This website dedicated to senior citizens maintains a directory of drug manufacturers. Website addresses and phone numbers are provided, and may prove useful when one needs to contact a manufacturer to determine if gluten is an ingredient in a medication.
*Note: There are a few gluten-free medication lists available online. It's important to remember that these lists need constant updating to be correct and lists can have mistakes, especially because manufacturers can change their ingredients any time and without warning. Gluten-free medication lists make a great starting point, but it is still important to talk to the manufacturer or your pharmacist to learn more about medications.