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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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    Guest Frances L. Garcia, MD, FAAP

    Posted

    Hello: This is a serious issue. I am a celiac and a physician. I can get information from pharmaceutical much easier than most, however, companies are reticent to provide it. They obtain non-active ingredients from different suppliers and therefor do not want the responsibility in case something goes wrong and someone is injured.Because it took about 15 years for a diagnosis in my case, I now suffer from the complications of continuing exposure: Autoimmune disease, a movement disorder, peripheral nerve damage due to B12 deficiency. This translates into a multitude of medications. The risk for gluten exposure is great. So yeah, we should demand that the FDA make the manufacture of gluten free medications a must.

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    Our family has also found that it is hard to find the necessary information for prescription drugs. Being in the hospital can even be a problem. It is listed on the chart celiac disease but it seems as though you have to constantly "police" the nutritionist and the pharmacy. It can be exhausting. One has to depend on family members for this.

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    I'm amazed how many "common" medications have gluten in them and determining this is not an easy task. I 100% agree that medications should be held to the same accountability as foods.

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    Just like hidden sugar can be bad for diabetics, hidden gluten is bad for those who can't handle it for whatever reason - celiac, gluten sensitivity, allergies. I don't like having celiac disease, but am looking forward to the day it would be more understood by the general public.

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    Of course, people should know what is in our medications.

    If a pharmacist or the company cannot confirm that an ingredient is not in a medicine that is a huge problem. Furthermore, I think doctors should know if the medicine they are prescribing is gluten free. I can't even tell you the number of times my primary care physician told me to "try to eat some crackers" or to take some medication that ended up having gluten or dairy even after I've told her and my chart says I have a severe allergy. I don't even see a primary care physician anymore because if I actually followed her advice I would be just as sick as I was before I found my holistic healthcare doctor.

     

    If the medicine had hidden sugar would diabetics know about it? It is just as serious a concern.

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    Guest Susan Pinvidic

    Posted

    Filling prescriptions is absolutely the most stressful thing I have to deal with since being diagnosed with celiac disease. I have had pharmacists literally roll their eyes at me. I had one tell me "honey, there is nothing back here with gluten in it". And the majority of them tell me "I have never had anyone ask for gluten free medication" to which I recently replied.."Really? because you helped me last year when I asked for the same thing". I called the pharmacy regional manager for CVS to ask why it is such a problem to have the pharmacist check and why there is so much attitude involved. He also told me that there is no gluten in medications. Honestly, it is so unbelievable how ignorant these people are considering it is their JOB to know what is in medications and how they will affect different people. My doc does write on the RX's that the medications need to be gluten free. That statement is largely ignored. I just wish I could find a pharmacy willing to take the extra time and not treat me like I am a crazy person taking a fad diet to the extreme. We should really all get together and file a class action suit against not only the FDA but the pharmacies as well. It is absolutely ridiculous that they take so lightly what is a very serious issue for many.

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    I have had several terrible reactions after being told "no gluten" when in reality there is. I am very sensitive and the tiniest amount of exposure dehydrates me within a half hour, not to mention all the other problems that result from exposure. In a perfect world we would be informed. I have also had an er doc mimic me when I told him I would not take anything until checking with the pharmaceutical company, this same doc asked me if I was on a "low" gluten diet. He also recorded that I was a difficult, non-compliant patient because I wouldn't take the medication he prescribed (which did contain gluten). My concern is that the medication will contain the same 20 ppm limit which is 20 ppm too much for my system. I rarely go to the doctor and look for old-fashioned herbal remedies for my symptoms instead! For those of you living in larger cities that have docs that are knowledgeable, you don't know how good you have it. I have to order a lot of my food on line or go without, no docs in this area know squat about celiac disease and don't care to.

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    I have had several terrible reactions after being told "no gluten" when in reality there is. I am very sensitive and the tiniest amount of exposure dehydrates me within a half hour, not to mention all the other problems that result from exposure. In a perfect world we would be informed. I have also had an er doc mimic me when I told him I would not take anything until checking with the pharmaceutical company, this same doc asked me if I was on a "low" gluten diet. He also recorded that I was a difficult, non-compliant patient because I wouldn't take the medication he prescribed (which did contain gluten). My concern is that the medication will contain the same 20 ppm limit which is 20 ppm too much for my system. I rarely go to the doctor and look for old-fashioned herbal remedies for my symptoms instead! For those of you living in larger cities that have docs that are knowledgeable, you don't know how good you have it. I have to order a lot of my food on line or go without, no docs in this area know squat about celiac disease and don't care to.

    Please note that a 20 ppm top end limit does not mean that a food or medicine will actually contain 20 ppm--it means that it can't ever contain over that level when tested.

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    Thank you so much for speaking out. It is so hard on the Florida central east coast to find a doctor that understand the issue, I have to spend endless hours on research. The last example is for an antibiotic prescribed for Rheumatic fever. After 3 days of research and 3 different scrips, the pharmacist guaranteed that that specific brand was definitively gluten-free. When it arrived a week later, I was informed that the insurance refused to pay for the gluten-free antibiotic. The total cost would have been close to $500! I refused to take the medication because it is too costly so I was labeled "non compliant" by the doctor. The joint pain from the Rheumatic fever would have been aggravated by the smallest amount of gluten found on the less expensive generic medications. As a nurse I am shocked that a great nation like ours does not protect the consumers. Thank you again for all that are trying to find a legal solution to this problem. I also hope that doctors will become more aware and start helping their patients.

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    I would like to sign Webers Petition. Address is on the last page as well as Mr. Webers address. I would like to know how much the pharmaceutical companies are bribed (or are to cheap) to use proper ingredients to make the drugs we have to use just to survive? A lot of foreign countries (China, southeast Asia; other countries) provide so-called fillers and binders to make the medications. This also includes VITAMINS and MINERALS. FDA needs to inspect them as well. Just saying!!!!!

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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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