FDA being Sued for Ignoring Gluten in Medicines
Seven years after petitioning the FDA to regulate the use of gluten in medicines Michael Weber has taken a bold step. He has filed a lawsuit against the FDA for failing to address his 2008 petition to exclude the use of gluten in all medications or as a secondary measure require the disclosure of gluten on drug labels. In 2011, the FDA sought public comments and we (GFT) participated by providing our point of view.
In a Wall Street Journal article dated 3/17/15 and written by Ed Silverman, Michael Weber’s decisions and actions are documented.
We have reprinted the Wall Street Journal article at the end of this blog for the benefit of our readers.
At GFT we have both business and personal insights into the matter of gluten contamination in drugs. As a manufacturer of a supplement made for celiac patients we have strong views regarding this subject. No gluten ingestion is acceptable for people with celiac disease. We have an intimate understanding of implementing procedures to qualify and monitor the ingredient supply chain against gluten contamination. It makes ingredient sourcing more complex and can add expense. But it can be done. We do it with our supplements.
We have firsthand personal experience with the negative consequences of FDA’s reluctance to address this issue. A family member with celiac disease had a car accident resulting in whiplash causing severe neck pain. A visit to the emergency room resulted in two prescriptions being written by the attending doctor. We knew that a generic drug would be difficult to trace. We told the doctor about our celiac disease and asked her to prescribe branded medications so we could verify the absence of gluten through the manufacturers. In spite of our request the doctor wrote us two prescriptions for the generic form of the prescribed drugs. When asked if she had researched them for gluten she said she could not help us with that. We began our search for reliable information regarding the possible presence of gluten in these drugs. We first had to convert the generic to a branded drug. We found all of the brands that made the drugs and called the makers. We found only one acceptable brand for each drug. We then called the doctor and told her what to prescribe and had her rewrite the prescriptions. This process took us three days! Three days of not having treatment for an injury that was acute enough to send us to the ER!
The current system discounts an entire population who cannot take drugs that contain gluten. It is unacceptable that every time a drug is prescribed for a celiac patient it leads to a long difficult search for information about the presence of gluten. The onus is put on the patient not the manufacture or the medical system to ensure the patients safety in taking their prescription. Not everyone has the resources or the knowledge to advocate for themselves. Hopefully with the publicity this lawsuit brings to this issue the FDA will look closely and require full labeling disclosure for both drugs and supplements just as they did with the recent food labeling law.
Wall Street Journal article, published March 17, 2015:
FDA is Sued for Failing to Regulate the Use of Glutens in Medicines
By Ed Silverman
What would you do if you are allergic to wheat gluten and, therefore, could not take certain medicines?
This is a dilemma for Michael Weber, who suffers from celiac disease, which is an autoimmune disorder that can occur in genetically predisposed people who ingest the protein. This can damage the small intestine and lead to neurological diseases, among other illnesses. However, the protein is sometimes used to coat prescription drug and over-the-counter medicine capsules, among other things.
After taking a generic drug seven years ago and developing side effects consistent with ingesting gluten, Weber petitioned the FDA to either eliminate wheat gluten in medicines or require new labeling on drugs containing the protein. The agency response has been slow. In 2011, the FDA sought public comments about the issue, but otherwise has not taken action.
So Weber has now filed a lawsuit to demand the FDA do something.
After taking the drug, “I called my pharmacy and they were not able to determine that drug was gluten-free,” says Weber, a medical office assistant in Eastchester, N.Y. “So then I had to find which manufacturer produced the generic. I went to their website and then had to speak to somebody at the company. They said that was not a gluten-free batch… So I had to discontinue taking the drug. I would like to be able to take drugs and not have any fears or go through all these hoops.”
In his lawsuit, he argues the failure to address the issue is hurting millions of Americans. About 1% of the U.S. population has celiac disease, according to the National Foundation for Celiac Awareness. “The absence of rules to address wheat gluten in prescription medications has serious and ongoing public health implications,” says Katie Einspanier, an attorney at Public Citizen, which represents him.
An FDA spokeswoman wrote us that the agency does not comment on pending litigation. We also asked what, if any, steps the agency may take to alert the public to medicines that contain wheat gluten and will update you accordingly. In 2011, a paper issued by the FDA Office of Food Safety detailed the adverse effects people with Celiac disease can suffer from exposure to gluten.
It’s not clear exactly how many medicines contain wheat gluten. A list maintained by Steve Plogsted, a nutrition support pharmacist at Nationwide Children’s Hospital in Columbus, Ohio, shows the protein is found in more than 150 prescription and OTC medicines. He tells us he obtains information from drug makers and government sources, and does this on a voluntary basis without funding.
Recently, the drug information service at Robert Wood Johnson University Hospital in New Brunswick N.J., began a database. But in a recent essay in the American Journal of Health-System Pharmacy, researchers noted most drugs “cannot be considered truly gluten free due to the lack of final product testing” and some drug makers could not verify the absence of cross-contamination during production.
“Unfortunately, there is no clear answer to the question of the prevalence of gluten in either OTC or prescription medications,” a spokeswoman for the National Foundation for Celiac Awareness writes us. “This highlights “the need for comprehensive research to identify safe thresholds of gluten in medication, its impact on people with celiac disease, and the pervasiveness of gluten” in production.
Meanwhile, spokespeople for the Pharmaceutical Research & Manufacturers of America, which represents prescription drug makers, and the Consumer Healthcare Products Association, which represents over-the-counter medicines, declined comment regarding the lawsuit and say they are uncertain how many of their members use gluten in their products.
In comments made to the FDA in 2011, the CHPA said the amount in OTC drugs where gluten “is not intentionally added is minute, especially when compared to the intake via the food supply.” The trade group also argued, though, that “banning use of specific grains would disrupt the supply chain, resulting in major reformulation of products.
“Reformulation to ensure elimination of gluten would have significant consequences to manufacturing cost and resources,” the trade group continued, adding that cross contamination could still occur. The CHPA, however, did suggest that labeling – such as the information provided for people who may experience allergic reactions – would be worth discussing.
Source: Wall Street Journal | Pharmalot March 17, 2015
This original article is made possible by Gluten Free Therapeutics. Our mission is to educate, inform, and provide the most effective nutritional products possible to allow those with celiac disease and serious gluten intolerances to heal their bodies. CeliVites complete line of superior gluten free supplements includes multivitamin/multimineral supplements, iron supplements, and calcium supplements for people living with celiac disease. All CeliVites products are designed to help you heal, restore and rebuild your body, because going gluten free isn’t enough!
I would sue them for sure. I am celiac and so is my daughter. I have been given a biologic for a year that I was not informed contained gluten. I think because the food industry has much $$ to gain from labeling gluten free is why they have pushed this. However if we regulate drugs and require labeling the drug industry will lose $$. Crazy being we could get lymphoma from these meds.
I wish I would have thought of filing a lawsuit. I have been so sick for years and tired of fighting with the pharmacies about my wheat/gluten and other allergies. I was told recently by Target Pharmacy that “they have no time to look into each of my prescription to make sure there no wheat/gluten in it.” It’s horrible!!
Could this be a class action suit?
I am positive that I am not the only person with Celiac Disease who would a solute ly join in a class action suit.
I’ll join in!
Class Action Suit, yes! You’ll need to speak with the representing counsel to the case.
I am in as well! My poor son is sick all the damn time because we ask and get told its ok, but then he will take a med and end up sick for several days. They dont understand that its physical and emotional pain from exposure 🙁
I have known I have had celiac disease for 20 years and I have had sooo many reactions from medications and am afraid to take hardly anything because of the fact that I’m not sure what medications have gluten and what medications don’t have gluten, the pharmacists Do Not take us seriously when we are asking about gluten in meds. I am glad that someone has addressed this problem and hope that they will start labeling the meds for us. It should be a class action suit, I would defanantly sign up
it should be a class action…. there are to many of us with Celiac’s ..I have just gotten to the point the only thing I take is stuff that I know the ingredients… so there are many meds I will not take even if the dr. prescribes it…
I have been diagnosed with Celiac since 2010. At first this was almost impossible with medications but I soon learned which generic medication makers used gluten as a filler and I chose to request the generic made drugs from other manufacturers. Now my pharmacist has a list of those generics I can take and those which will cause a reaction. It’s important that I educate new pharmacists and staff but it’s for my own health. It IS sad that the FDA will not do this for us but I certainly am not waiting for them. Every time you see a new doctor, teach them about Celiac and how it affects your medications and how they need to be responsible in prescribing drugs. With all of us doing this we can show the FDA how it SHOULD be done!
I was diagnosed with Celiac disease in the EARLY 1980’s, at the ripe age of 18 months, while on my death bed, weighing less than 5lbs.
I have ALWAYS had issues with meds and, to this day, HATE taking them. Maybe this is why?!? I had to rely on the doctors at such a young age, to help and protect me, so I only recently discovered that MANY of the meds I have been taking or been prescribed in my life have had gluten in them, including some over-the-counter meds that were recommended to me. I now have multiple ‘auto-immune diseases’ which they say will happen to those who do NOT follow their gluten-free diet strictly.
I would love to join a class actions suit for changes to the regulations in labeling. THIS NEEDS TO BE DONE. Thank you Micheal Weber, for being strong and taking action where action was needed. All of us that are gluten sensitive or Celiac, deserve to know what is in our food, meds and supplements to ensure we are not creating health issues while trying to ‘improve’ our health!!!
I would absolutely join a class action suit on this!!!!! How can we do that? I was diagnosed in 2006, and my meds are incredibly hard to check, as my low-income insurance requires generics. They aren’t even the same generic from refill to refill, just whatever is cheapest.
The FDA is causing us all serious harm!
.I CERTAINLY UNDERSTAND WHERE YOU ARE COMING FROM!!! .I WAS DIAGNOSED IN 2009..CAME VERY CLOSE TO DYING FROM MISDIAGNOSIS & ALSO HAVE MULTIPLE OTHER AUTOIMMUNE DISEASES.. THE MANUFACTURERS OF MOST OF MY MEDS CANNOT CERTIFY THAT THEY ARE GLUTEN FREE BECAUSE THERE ARE NO REGULATIONS OR LAWS TOMAKE THEM GLUTEN FREE. .AND THEY ARE NATURALLY NOT DEDICATED FACILITIES, THEREBY LEAVING ALL CELIACS VULNERABLE TO THE TOXIC EFFECTS OF MEDICATIONS OUR DOCTORS FIND NECESSARY TO PRESCRIBE FOR US, SOME LIFESAVING. I . WILL BE GLAD TO FILE A PETITION OR WHATEVER IS NEEDED TO ADDRESS THIS MEDICAL HEALTH CRISIS. YOU CAN REACH ME VIA MY EMAIL.
I have been diagnosed with Celiac as well. I did not even know that medications could have gluten…help all of us with Celiac.. on board if there is a class action suit.
Celiac on board as well!!!
This is extremely interesting! I am seriously gluten intolerant. It is no wonder that I can clean up my diet but yet still have symptoms taking meds!! I just assumed that medications wouldn’t include an ingredient that makes so many people sick! Count me in if a class action occurs!!!
I was actually just wondering that myself! I was wondering if my medications were actually keeping me sick!
My son has Celiac and this is appalling! To be injured, have the doctor not even prescribe a named med and then take 3 days… let alone the FDA not recognizing the need!
I would sue indeed, and I agree it should be a class action suit!
I to have Celiac and the drug store knows it but they need to stop the gluten in drugs. I support this message…gluten aggravates a thyroid condition…and a host of other diseases…they are selling poison…go get ‘them. They need to be stopped.
I agree it should be a class action suit!
I Have problems with my medication for Hashimotos Thyroiditis that has gluten, I am totally GF accept this, as my insurance will not pay for Tirosint as it’s much mor expensive… it is pure hormone replacement no Gluten and worked perfectly… Yes this is unacceptable to those of us that do NOT tolerate Gluten.
We diligently researched medication for hashimotos thyroiditis. We found that Tirosint is the only thyroid hormone on the market that does not have gluten. It is unacceptable that your insurance will not pay for this medication. Perhaps a call to your provider would help. hashimotos and celiac disease are linked and there are thousands of people on it. See our blog on hasimotos https://www.glutenfreetherapeutics.com/living-gluten-free/medicine-research/hashimotos-thyroiditis-celiac/. We were shocked to find that there is only one medication to serve what is such a common problem.
I have Celiac! Florida makes you take generic drugs. All meds are filled with generic drugs unless there is no generic for the meds. It’s so difficult getting brand meds here. I’m on board with a class action suit!
Hi I have had celiac since 2004 my aunt was the one who actually informed me of this because she was having dental surgery done and got really severally sick and we called her doctor and dentist said that the numbing medication used is basically like shooting a loaf of bread into your body
Wow it’s Sad when you have Celiac Disease & are Afraid to go to the Dentist Also, What Next? I’m getting more scared by the second but things are finally fitting into place now it makes sense why my life & diet are changed but I’m Still getting Sick!
what numbing agent did they use? I need to have a spot on my tongue biopsied in a few weeks, now i’m concerned.
I have been diagnosed with Celiac Disease for over 4yrs now & it’s Hell enough to change everything in your life but also have to worry about the meds the doctors are prescribing us for other illnesses and reasons that shouldn’t be OUR BURDEN TOO Especially if I’m sticking to my diet & lifestyle to the fullest!! The FDA Should Guarantee Our Safety in Our Meds!! No Matter How Strict I Am With My Diet I’m Still in Severe Pain in My Gut EVERYDAY & The Rash WON’T GO AWAY EVER & FOR A WOMAN IT’S SO EMOTIONALLY BREAKING NOT TO MENTION PAINFUL!!
I’M DEFINITELY IN IF THERE’S A CLASS ACTION SUIT I’M COMPLETELY 100% IN!! I’M IN HELL EVERYDAY OF MY LIFE SOME DAYS CAN’T GET UP THE PAIN IS SO BAD!! IF ANYONE KNOWS HOW TO GET ON BOARD WITH A SUIT PLEASE PLEASE LET ME KNOW!! THANK YOU FOR THE INFO I DIDN’T KNOW ANY OF THIS ITS PROBABLY WHY I CAN’T GET BETTER!!
I have a page long of drugs that make me sick vomiting diarrhea .. Last year they found 7 yes 7 ulcers and was on IV drugs .. When they discharged me I asked the hospital doctor to ask the pharmacist to come in. She did and told me no this drug would be safe to take .. 2 days later my family had to call 911 because I could not leave the bathroom it was coming from both ends and the pain was off the 1-10 it was 20.. They take me back to the hospital 6 hours in ER the doctor called my pharmacies and they called the manufature of the medication they said we have no control if it has or if it does not .. Well we found out it had WHEAT STARCH in the inactive part of the medication. A total of 4 pills and now another 7’days in the hospital because it put me in a celiac attack. This is happened so many times they look at my allergies and say how can you be allergic to all this I tell them I am not allergic to the active med.. It is the fillers they put in to hold the pill together or as a preserving the pill .. They use wheat starch, rice starch, corm starch. Or any combination of the above.. But for some one that is sever sever sever Celiac it hills me and then to heal from taking in any small or media or large amount of gluten is the same months of healing the stomach again.. What people don’t understand it is killing us .. If it was a poison you would tell people there is a poison in that medication.. PLEASE PLEASE disclose what is in the medications all that is in the medication….I have been dealing with Celiac for,over 30 years please stop making me sick because I have to take a medication to get well.. But then take it then end up,I’m the hospital…
YES. CLASS ACTION.. For all who have become sick because they will not tell us that WHEAT is in MEDICATION If it was peanuts and u killed somebody then it would be removed..
WELL YOU ARE KILLING ME.
The squeaky wheel gets all the attention! Well, there’s an estimated 3 million Celiacs in the USA, so let’s start squeaking! Class action makes more noise than a few news articles.