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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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    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.

    Wow! I thought I was aware and safe guarding myself, yet have not even considered cross contamination from the pill counting method being used! I'm so glad you brought up that point to check!

    I've gotten glutened from several medications, and share the same frustrations with getting the correct information as everyone has mentioned.

     

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    I take a generic levothyroxine and a few other things, gluten in meds is a concern. Especially since our insurance requires us to mail order our meds from a large pharmo-insurance middleman (Express Scripts). Trying to explain I need gluten-free meds and the same levothyroxine manufacturer to their Philippine call center staff is loads of joy.

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    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'.

    @Aims, you must not be a celiac. You are correct that describing wheat as a protein is not accurate. However wheat GLUTEN is a protein that we celiacs react to. There are some wheat products where this PROTEIN has supposedly been removed. However, some people are so sensitive they even react in those cases. There are times when the 20 ppm food labeling standards are useless for me because I react to much less exposure.

     

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    Yes, absolutely! I can't believe they haven't done it yet. It is so hard for people like us with celiac disease to stay safe. I also had a thyroidectomy October 2013, therefore I must take hormone replacement for the rest of my life, and even those medicines are iffy. I just stopped taking liothyronine by Sigma Pharm, because I've been really sick lately....who knows There's probably gluten in it!

    I just wanted to say that in Nov 2013 I started taking Sigma Pharm Liothyronine and within about 6 weeks I started having a terrible reaction - it started with acne, soon moved to terrile cystic acne and I never even had acne as teen. My asthma was terrible, I always felt like I couldn't catch my breath. I lost 10 pounds and am already quite thin. I was never sleeping but always tired. My emotional state was just off the charts - I was so 'nuts' I could barely be around myself. All this and my TSH was perfectly consistent for me. It was awful. After 4 months, Feb 2014 I changed to Paddock labs and it took about 2-3 months before my body seemed to 'heal'. I also am celiac...I knew it was the Sigma Pharm that caused these problems, I wonder if it was gluten. I did have my igg/iga checked in Dec 2014 but that was 10 months.

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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.

    While I agree it is absurd that the manufacturer should not be required to print ingredients as food manufacturers are required to do - I must point out that the minority of the populate is celiac (I have celiac) and to ban gluten to protect the minority is also 'absurd'. If the world caters to us with celiac, then why wouldn't the world cater to everyone....including those without celiac? Legislation is a slippery slope that will always be used against everyone at some point so be careful what you wish for. Information should always be required and legislated, but to legislate action such as bans or testing - that will inevitably be used against you at some point. If they can require a ban for gluten they why can't they require a ban on sugar to accommodate the diabetics? Or a ban on peanuts to protect those with peanut allergies? Personally, I'd like to ban certain plants and even certain perfumes because I have awful allergies..... Be careful what you wish for.

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    WOW!! I had no idea it was this bad. I have taken very few medications but 3 years ago I had major stress level taking care of my elderly Godfather. I began the anti-depressant Celexa. After about 3 months I began having severe diarrhea. 4 doctors, including UCLA Celiac Center told me not to stop the pills as I was severely depressed going to the bathroom a minimum of 40 times per day. Dizzyness is also a side effect but I did not have a problem with that until I took a Lomotil along with the Celexa. I had 2 minor car accidents in one week. Went off ALL meds and was FINE in two weeks. Two years later I tried two more anit-depressants which I began SEVER diarrhea within 48 hours of both. I never knew I could contact the drug companies. This HAS to stop!

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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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