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FDA says that most drugs are gluten-free???


Pat B

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Pat B Newbie

I was very surprised to read the following in the link below:

Medications and Gluten | FDA

What types of ingredients that may contain gluten are in oral drug products?

The majority of oral drug products either contain no gluten or virtually no gluten.

Based on information available to the Agency, we are aware of no oral drug products currently marketed in the United States that contain wheat gluten or wheat flour intentionally added as an inactive ingredient. We would expect any such product, if it existed, to include wheat gluten or wheat flour in the list of ingredients in its labeling.

FDA has identified very few oral drugs that contain wheat starch as an ingredient. Starch can also be used as a starting material for manufacturing various ingredients found in oral drugs. Starch used for this purpose is often corn starch or potato starch, not wheat starch. Even if wheat starch were used, either as an ingredient or as a starting material, there would be very little gluten, if any, expected to be present in the ingredient or the drug product. Very few, if any, oral drug products contain ingredients derived from barley or rye.

Typically, how much gluten is in a drug product?

The vast majority of oral drug products either contain no gluten or virtually no gluten. In the very rare cases where gluten may be present, we estimate based on drug formulation information that wheat starch and other ingredients derived from wheat would contribute no more than 0.5 mg gluten to a unit dose of an oral drug product. This amount is less than may be found in a single 30-gram serving of food labeled gluten-free according to FDA’s regulations.   

Does this mean we no longer have to be so particular in what manufacturers we use?  I'd be interested in everyone's thoughts.

Thanks!


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Scott Adams Grand Master

For most celiacs prescription medications, even if they used wheat starch as an ingredient, would not contain enough gluten to trigger issues, however, for those who are super sensitive even tiny amounts of gluten can be an issue.

You can search this site for prescriptions medications, but will need to know the manufacturer/maker if there is more than one, especially if you use a generic version of the medication:

To see the ingredients you will need to click on the correct version of the medication and maker in the results, then scroll down to "Ingredients and Appearance" and click it, and then look at "Inactive Ingredients," as any gluten ingredients would likely appear there, rather than in the Active Ingredients area.

 

  • 2 weeks later...
Kathleen Mostek Newbie

I had to stop many medications due to being glutened. I slowly took one medication at a time and did a “drug holiday” of at least a week. If I was not sure, I waited a few weeks and tried again. Interestingly, some medications that I was on for decades, were outsourced to a specific company in India. Some meds had 15 or more additives! It took hours of research to document additives. The FDA allows a small % of potential glutens per pill. If you are taking multiple meds….that is a statistical risk.

Scott Adams Grand Master

Did you look up your meds on the government website I shared? It should list all additives.

Kathleen Mostek Newbie

Scott,

I used the AI app Perplexity. I did use your recommendation for research as well, however one med was not the color or shape, after being outsourced to India. I called Blue Cross, spoke to a pharmacist, he also did not have the correct description of the drug from India! 37 additives!

Tuba1971 Newbie

I had been glutened from somewhere since I pretty much make all my food from scratch. I had to have an endoscopy which should gluten damage, had blood work which also indicated high gluten. 4 years ago when I had these tests my gluten levels were all in good alignment. It comes down to my levothyroxin accord brand that must have gluten in it. I switched to synthroid 3 weeks ago and have been doing much better and am able to sleep at night again.

Scott Adams Grand Master
19 hours ago, Kathleen Mostek said:

Scott,

I used the AI app Perplexity. I did use your recommendation for research as well, however one med was not the color or shape, after being outsourced to India. I called Blue Cross, spoke to a pharmacist, he also did not have the correct description of the drug from India! 37 additives!

Thanks for this update, and it is scary that drug manufacturing is being outsourced to India, a country that is notorious for having very little, or extremely relaxed business regulations. 


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Pat B Newbie
On 4/2/2025 at 1:22 PM, Scott Adams said:

Did you look up your meds on the government website I shared? It should list all additives.

Yes, and they were OK. 

 

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