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    FDA Sued for Failing to Keep Gluten Out of Medicines

    Reviewed and edited by a celiac disease expert.
    FDA Sued for Failing to Keep Gluten Out of Medicines - Photo: CC--Sponge
    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.

    Celiac.com Sponsor (A12):
    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 Open Original Shared Link.

    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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    Guest Jenny

    Posted

    I have a similar story and we too will be filing a lawsuit against the FDA when our vaccine hearing is complete. We asked the FDA CDC etc. in 2008 to label the tdap containing milk. Milk (& gluten) damages my husband's stomach and prior to vaccine doc noted Iga positive to gluten and casein yet injected vaccine without proper knowledge and labeling. Destroyed his adrenal glands and stomach parietal cells within 7 days. Many letters sent to the FDA etc begging for labeling and their responses are unbelievable. Need to find an attorney for our case.

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    Guest Janet

    Posted

    In UK, this already exists in prescribed medicines.

    OTC items are different.

     

    Wishing my USA Coeliac friends..improved health....

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    Guest Candace

    Posted

    I have to take thyroid meds. What good is it if the meds are poisoning me? Yes. Gluten should be labeled everywhere.

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    Guest Aims

    My pharmacist studies every drug prescribed for me via the information he can get - before issuing my medications.

     

    I've had so many problems with gluten in my meds and it took me a long time to discover what was the cause.

     

    I'm surprised the FDA isn't concerned about this. If there was otherwise something harmful in the medications they'd be all over it.

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    Guest Aims

    Calling wheat 'protein' is a misnomer. It is actually more carbohydrates than protein. It also contains fiber, vitamins, trace metals, and sugar.

     

    A better choice of a word would have been better than 'protein'.

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    Guest Luann

    Posted

    This is not a COURTESY. This is a HEALTH ISSUE.

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    Guest Barbara

    Posted

    I took a generic medicines while in the hospital and it made me sicker then the condition that brought me to the hospital. It was not until I got back on the brand name medicines prescribed by my doctor that thing began to clear up. All drug should be labeled gluten-free or non-gluten-free so choices can be made that will enhance well being and healing.

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    Guest Lynard

    Posted

    This is huge.

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    Guest Liz

    We must have gluten labeled. We must have GMOs labeled. Newest issue: Arsenic in wines. WTH are they thinking?

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    Guest Barb

    Yes, medicine should be labeled for people with celiac. Some people take many meds so they may have a constant detrimental affect and we are powerless to even investigate. Even my pharmacist has no way of knowing the fillers or additives from batch to batch coming from overseas suppliers. Especially the generics! Which our insurance wants us to use. I would think that everyone would want to know this, not just celiac patients!

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    Guest marie

    Posted

    I am tired of asking pharmacists if this medication is gluten free and them telling me they don't know and for me to call the drug company myself. As a pharmacist, they should know this, just as they are supposed to alert you if a medication you may already be taking, will interact poorly with the new medicine.

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    Guest Jen

    I've gone to pharmacists who have no idea and I have the prescription transferred. I go to Wegmans now.

    But, even there they read the ingredients and aren't sure what is it so they call the company. One of the issues is that companies aren't open on weekends.

    Another issue that should be addressed are hospitals that don't know what gluten is and are serving meals that either contain gluten and shouldn't or that aren't balanced... like a pudding cup for dinner because that was all they could find that was labelled gluten free.

    I'm glad someone is suing! There is no reason gluten can't clearly be labelled as should peanuts, dyes, wheat, etc.

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    Jefferson Adams

    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. His articles, essays, poems, stories and book reviews have appeared in numerous magazines, journals, and websites, including North American Project, Antioch Review, Caliban, Mississippi Review, Slate, and more. He is the author of more than 2,500 articles on celiac disease. His university coursework includes studies in science, scientific methodology, biology, anatomy, physiology, medicine, logic, and advanced research. He previously devised health and medical content for Colgate, Dove, Pfizer, Sharecare, Walgreens, and more. Jefferson has spoken about celiac disease to the media, including an appearance on the KQED radio show Forum, and is the editor of numerous books, including "Cereal Killers" by Scott Adams and Ron Hoggan, Ed.D.

    >VIEW ALL ARTICLES BY JEFFERSON ADAMS

     


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