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    FDA Sued for Failing to Keep Gluten Out of Medicines


    Jefferson Adams
    Image 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.


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    Photo: CC--SpongeRemember, 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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    Guest Deborah Ross

    Posted

    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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    Guest Michael

    Posted

    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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    Guest diane

    Posted

    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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    Guest Ann W

    Posted

    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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    Comments are fine, but what we need are amicus briefs filed by all of us who agree with this action.

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    Guest Shelley

    Posted

    We have every right to know; I think this is awesome! Even my vitamins I always order from Puritan pride are listed gluten free, soy free, etc., as does Costco.

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    Guest Stephanie

    Posted

    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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    Guest Susan Holmes

    Posted

    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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    Guest Linda

    Posted

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

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    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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    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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    Guest Cindy

    Posted

    I hope the FDA will now act on gluten in medicine. I can no longer tell if I've been glutened at least in the short term. I don't worry about food only my meds. I will have no way of telling until I've been poisoned for several days. I keep tract of my medicine and when I open a new bottle. It would be so nice if I didn't have to worry about my medicine making me sick.

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    Jefferson Adams is a freelance writer living in San Francisco. He has covered Health News for Examiner.com, and provided health and medical content for Sharecare.com. His work has appeared in Antioch Review, Blue Mesa Review, CALIBAN, Hayden's Ferry Review, Huffington Post, the Mississippi Review, and Slate, among others.

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    BMC Pediatrics

    Jefferson Adams
    Celiac.com 07/16/2018 - Did weak public oversight leave Arizonans ripe for Theranos’ faulty blood tests scam? Scandal-plagued blood-testing company Theranos deceived Arizona officials and patients by selling unproven, unreliable products that produced faulty medical results, according to a new book by Wall Street Journal reporter, whose in-depth, comprehensive investigation of the company uncovered deceit, abuse, and potential fraud.
    Moreover, Arizona government officials facilitated the deception by providing weak regulatory oversight that essentially left patients as guinea pigs, said the book’s author, investigative reporter John Carreyrou. 
    In the newly released "Bad Blood: Secrets and Lies in a Silicon Valley Startup," Carreyrou documents how Theranos and its upstart founder, Elizabeth Holmes, used overblown marketing claims and questionable sales tactics to push faulty products that resulted in consistently faulty blood tests results. Flawed results included tests for celiac disease and numerous other serious, and potentially life-threatening, conditions.
    According to Carreyrou, Theranos’ lies and deceit made Arizonans into guinea pigs in what amounted to a "big, unauthorized medical experiment.” Even though founder Elizabeth Holmes and Theranos duped numerous people, including seemingly savvy investors, Carreyrou points out that there were public facts available to elected officials back then, like a complete lack of clinical data on the company's testing and no approvals from the Food and Drug Administration for any of its tests.
    SEC recently charged the now disgraced Holmes with what it called a 'years-long fraud.’ The company’s value has plummeted, and it is now nearly worthless, and facing dozens, and possibly hundreds of lawsuits from angry investors. Meantime, Theranos will pay Arizona consumers $4.65 million under a consumer-fraud settlement Arizona Attorney General Mark Brnovich negotiated with the embattled blood-testing company.
    Both investors and Arizona officials, “could have picked up on those things or asked more questions or kicked the tires more," Carreyrou said. Unlike other states, such as New York, Arizona lacks robust laboratory oversight that would likely have prevented Theranos from operating in those places, he added.
    Stay tuned for more new on how the Theranos fraud story plays out.
    Read more at azcentral.com.