People With Celiac Disease Must Also Check To Ensure Medicine is Gluten Free

People with celiac disease face a dilemma when it comes to medicine. Many medicines are bulked up with wheat derivatives which contain gluten. The gluten protein is used to coat prescription drug and over-the-counter medicine capsules, among other things.

The only treatment for people with celiac disease is to go on a 100% diet for the rest of their lives. So, how do they cope when they need to take prescription medicine or even over the counter pain killers? For a person who suffers from celiac disease, this is a very serious issue which needs to be addressed urgently.  

Many celiac sufferers report that some of their worst episodes of gluten poisoning have resulted from the ingestion of gluten used in prescribed medication. Most refuse taking most pain killers, even after surgical procedures, because they contain gluten. What is worse dealing with the pain of surgery, or dealing with symptoms of a gluten reaction; gut pain, joint pain, headaches, fiercely itching skin, and so on.

The answer seems like it should be straightforward. Like with food, they must also become expert label readers of medicine bottles. But the problem is that the FDA does not have labelling laws for medicines like they do for food.

Currently, unless a medication is specifically labelled as gluten free, so calling the manufacturer is the only way to confirm the medication's gluten-free status. However, very few medications are labelled as gluten-free. Inactive ingredients may be listed on the box or the package insert, but it is difficult, if not impossible, even for doctors or pharmacists to tell if these are derived from gluten.

In general, any starch ingredient including pregelatinized starch and sodium starch glycolate which is not labelled specifically as being derived from a gluten free source, such as corn, potato, tapioca, should raise alarm bells for the person with celiac disease.

Furthermore, other inactive ingredients that might come from wheat or barley and contain gluten include; dextrates, dextrins, dextri-maltose, and maltodextrin.

Because many pharmaceutical companies are not gluten savvy, they may not know themselves if their medications are gluten free. They may not know the gluten free status of the raw materials they buy from outside suppliers. The possibility of cross-contamination during the manufacturing process is another potential problem. As with food companies, pharmaceutical companies also need to be trained in the HOW of gluten free. 

Here is an e-book I wrote for the hospitality industry – the principals would be the same for the pharmaceutical industry so it would be worth the read.

Many pharmacists and pharmacies are blasé, careless and unsympathetic and have no understanding of celiac disease and their need to be gluten free. Doctors also do not seem to be aware that prescription drugs often contain gluten and may prescribe medicine which will have a detrimental effect on a person's health.

Early on 2015, an American called Michael Weber sued the FDA for failing to regulate the use of glutens in medicines. About seven years ago he had a reaction to gluten after taking some generic drugs, so he petitioned the FDA to either eliminate gluten in medicines or develop new labelling laws to deal with drugs which contain gluten.  A fair enough proposition I would think, considering there are such strict labelling laws for gluten in the food industry. The agency response has been slow. In 2011, public comments about the issue were sought by the FDA, but otherwise, no action had been taken.  So Weber filed a lawsuit to demand the FDA do something.

In his lawsuit, Webber argues that the failure to address the issue of gluten in medicine is affecting millions of Americans. That is because about 1% of the U.S. population has celiac disease. “The absence of rules to address wheat gluten in prescription medications has serious and ongoing public health implications,” says Katie Einspanier, an attorney at Public Citizen, which represents Webber

Michael Weber v. Food and Drug Administration (FDA) (Gluten) 

Description:

In 2008, Michael Weber submitted a citizen petition to the Food and Drug Administration requesting that the FDA ban the use of wheat gluten in both prescription and over-the-counter drugs or, in the alternative, that the FDA require that drugs containing gluten be labelled to disclose that fact. In March 2015, the FDA had yet to grant or deny the petition. Representing Mr Weber, Public Citizen sued the FDA for its unreasonable delay in responding to his petition, seeking an order directing the FDA to act on the petition. In response to the lawsuit, the FDA responded to Mr Weber’s petition, granting the petition in part and denying it in part. We then dismissed the lawsuit.

Currently, it is quite difficult to determine if a drug contains gluten or not because there is no labelling requirement. Sometimes not even the pharmacist has that and either the pharmacist or the patient have to phone the pharmaceutical company who manufactures the drug to find out.

And if it contains gluten what do you do? Most people with celiac disease will not take the drug or may have to discontinue it because it has made them sick. Most people with celiac disease would like to be able to take their prescribed drugs or painkillers without fear or without having to go through all these hoops.

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No one seems to know exactly how many medicines contain wheat gluten.  Some lists are available on the internet but I would be cautious about relying on such lists because a manufacturer can change the recipe without notification. Just a change in one ingredient could introduce gluten into the mix. Another concern is that and some drug producers cannot verify the absence of cross-contamination during production.

The fact is that drug manufacturers are not bound by the same regulations as food producers and there is not a requirement to test the drugs for gluten. Therefore, most drugs cannot be considered 100% gluten free due to the lack of final product testing. There is a need for a comprehensive investigation to identify what the safe thresholds of gluten are in medication, the impact these levels have on people with celiac disease, and ways to cheaply and easily produce gluten free drugs.

At the moment, most drug companies believe that the complete elimination of gluten would have significant consequences to manufacturing cost and resources and they are not confident that they would be able to prevent cross contamination. Banning the use of gluten-containing grains would disrupt the supply chain, resulting in the need for a major reformulation of products with significant consequences to manufacturing cost and resources.

The food industry has had to reform if they want to provide gluten free products for their customers with celiac disease, so why can't the pharmaceutical industry? Pharmaceutical companies are certainly wealthier than their hospitality cousins. I only hope that this pending suit against the FDA will shake up the industry and new laws and regulations will soon come into force.