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  • Jefferson Adams
    Jefferson Adams

    FDA Sued for Failing to Keep Gluten Out of Medicines

    Reviewed and edited by a celiac disease expert.

    Caption: Photo: CC--Sponge

    Celiac.com 03/18/2015 - A man who suffers from celiac disease has sued the FDA for allowing gluten to be used as a coating on prescription drug and over-the-counter medicine capsules.

    Remember, people with celiac disease can suffer intestinal damage when they consume gluten. This can damage can lead to neurological, among other disorders.

    The man, Michael Weber, was taking a generic drug seven years ago, and developed side effects consistent with ingesting gluten.

    Weber says he was unable to determine the drug’s gluten status through his pharmacist, and

    Weber went on to petition the FDA to either eliminate wheat gluten in medicines or require new labeling on drugs containing the protein.

    In 2011, the FDA sought public comments about the issue. In 2014, the FDA issued gluten-free definitions and labeling standards for commercial foods, but has failed to act on drugs. So Weber has now filed a lawsuit to demand the FDA do something. The complaint can be read here.

    This raises a couple of questions: Do people with celiac disease deserve to know if there is gluten in their medicine? Do they deserve access to medicines that are gluten-free? Should the FDA definitions and labeling standards also apply to drugs and medicines?


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    Absolutely!! We have every right to know!!! The tiniest amount of gluten makes me "hospital sick", I am so very sensitive to it.

     

    Why shouldn't the same laws apply to all? The same allergens apply to us...food or drugs!

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    After discovering my Dad and I had celiac disease I was amazed that it was so hard to figure out if medications contained gluten. Pharmacists didn't know and were dismissive when asked if they could find out. My Dad's pharmacist told him to check the internet. He doesn't even know how to use the internet. On several occasions I was given the number of a drug company and told to call them myself, which is fine except that the company ask which pharmacy I was calling for and I wasn't representing any pharmacy. Recently things have gotten better at the pharmacies near me but why did it take so long?

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    This was good but more detail would have been even better. I have had (Rochester, NY area) good luck getting medications gluten free at Wegmans Pharmacy. I like the fact that they list all ingredients plus allergens list on the otc meds, as I have had to learn to become a constant label-reader...

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    Thank you so much Michael Weber! Finally one of us came up with the money to litigate! A pharmacist or technician has to phone manufacturers of generic drugs, which can take five days, to find a gluten-free version. Then they usually have to order the drug, and I wait two more days. This is because they run pills through a counting machine, where they get contaminated with gluten. I have to go into the pharmacy every time and remind them that they have to do this and count out the pills by hand with clean equipment. I have to call and check the progress and verify who counted them out and if they used my special protocol when I pick up the prescription. Once they forgot and ran some of my tiny thyroid pills through the machine. I had just changed my cell phone number and they did not get ahold of me until I had taken 6 pills. I then developed pyloric spasms for 6 days and gluten ataxia for 4 months. We need the FDA to ban gluten in all medications, including over the counter. I am afraid we need a national policy of testing all people for celiac disease and development of tests for non-celiac gluten sensitivity before we have enough political clout to have this come to pass, policies I'm sure the all powerful corporations will prevent for the rest of my life.

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    I have had the same issue with my prescription drugs. My pharmacist does what he can to find out, but I've had to take risks I am not happy about. We recently had the conversation again when my insurance company would not pay for the gluten free medication I had been taking and instead made the pharmacy change to a drug that the pharmacist could not confirm. It's time for ALL labeling to be mandatory from GMO to allergens, etc.. We have the right to know what we are consuming whether for pleasure or health.

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    Would anyone question that someone with diabetes needs to know the sugar content in the food or medicine they are consuming? Should a child with a peanut allergy be informed if the medicine has peanuts? Why shouldn't gluten be treated the same? People don't understand that CELIAC is a REAL disease. The world is consumed with the fad diet of avoiding gluten, and the inevitable backlash of haters for the gluten intolerant. This has a detrimental effect on the TRUE gluten intolerant who have an auto-immune DISEASE that can HARM them if they consume gluten. Public attitude seems to be "oh come on, gluten won't really hurt you, you are just doing it as a fad." Hopefully meds will become better labeled. I always ask the pharmacist and they typically say "oh yeah, it's gluten-free" but now I know I probably shouldn't trust that dismissive answer.

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    I agree. We DO have a right to know what we are ingesting: food or drugs. I , too, have had the answer" check the internet." If I can't prove it's gluten free, then I can't take it. And my Docs all know that, too. YES, the FDA needs to fix this.

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    I tried calling a manufacturer and they didn't understand me. Now I am on every junk mailing list. I know it is them because my name is Stephanie and they called me Stephen. All the mail comes addressed to Stephen.

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    I wish they would require medications to list all the known allergies. I react to cow milk also. The gluten labeling should also include any medications that are gluten derivatives. My daughter cannot have vitamins that are derived from gluten but supposedly have all the gluten processed out.

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    Absolutely medications should be labeled. For many years Synthroid was the only thyroid medication and they state that they do not know if there any gluten. Too bad for all of us who had no choice but to take it anyway. In the last few years the generic Synthroid states that it is gluten free.

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  • About Me

    Jefferson Adams is Celiac.com's senior writer and Digital Content Director. He earned his B.A. and M.F.A. at Arizona State University, and has authored more than 2,000 articles on celiac disease. His coursework includes studies in science, scientific methodology, biology, anatomy, medicine, logic, and advanced research. He previously served as SF Health News Examiner for Examiner.com, and devised health and medical content for Sharecare.com. Jefferson has spoken about celiac disease to the media, including an appearance on the KQED radio show Forum, and is the editor of the book "Cereal Killers" by Scott Adams and Ron Hoggan, Ed.D.

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