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Found 19 results

  1. Celiac.com 12/12/2018 - In a step that health officials say could provide immediate relief to the estimated eight million Indians who suffer from celiac disease, the Indian government is assessing a plan to require drugmakers to declare any gluten ingredients on medical labels. India’s chief drug advisory body will discuss the issue at its meeting scheduled in early December, said people with knowledge of the plan. The Drug Technical Advisory Board’s decision to address the issue of gluten-free labels for drugs and medicine comes on the heels of an active recommendation by the department of physical medicine and rehabilitation at the All India Institute of Medical Sciences (AIIMS). In addition to clear gluten-warnings on all medical labels, experts at AIIMS have proposed changing the law to force drug makers to actively avoid gluten-containing ingredients in drugs or medicine. The proposal aligns with guidelines drafted by the US Food and Drug Administration (FDA) in 2017. Those guidelines call for drug makers to properly label medications that contain gluten. The FDA also recommends that drug makers include a voluntary statement that indicates that the product contains no gluten, or any ingredient made from wheat, barley, or rye. Proper labeling of drugs and medicines is getting a great deal of attention from regulatory bodies over the last couple of years. Look for that trend to continue and for new guidelines to drive new labeling practices for medicines containing gluten ingredients. Overall, this is an extremely positive development for anyone with celiac disease or a medical gluten-sensitivity. Until such new guidelines make it to the pharmacy, be sure to check with your pharmacist about any drug or medicine you think might contain gluten. They are in a strong position to help, and can usually get answers to such questions. Lastly, stay tuned for more news on the official labeling decision by India's Drug Technical Advisory Board. Read more at: LIVEMINT.COM
  2. Celiac.com 08/22/2018 - There’s been some data to support the idea that local pharmacists might have an important role to play in helping people with celiac disease to remain gluten-free by providing information about possible gluten in drugs, and even liaising with manufacturers for gluten information on the patient’s behalf, as needed. But how solid is your local pharmacist when it comes to celiac disease awareness? A team of researchers recently set out to evaluate pharmacists' knowledge of celiac disease, and to look for areas where further information may be beneficial. The research team included Carmela Avena-Woods, PharmD, BS Pharm; Robert A. Mangione, EdD; and Wenchen Kenneth Wu, PhD, MBA. They are all with St. John's University in Queens, New York. To gather data for their evaluation, their team sent a survey to community pharmacists who practice in a national chain pharmacy in one region of New Jersey and New York. A total of 418 pharmacists, just under 40%, responded to the survey. Sixty percent of the responses correctly noted that there are currently no federal regulations requiring manufacturers to designate medications as gluten-free. Still, forty percent got that wrong. Perhaps most alarmingly, of the pharmacists who claimed a basic or advanced understanding of celiac disease, only 27% correctly indicated that celiac disease is both an autoimmune and a chronic lifelong disease. Interestingly, twenty percent of pharmacists said they often suggested a change of diet to people with suspected celiac disease before a clinical diagnosis was made. This study suggests that community pharmacists have some understanding of celiac disease, but that additional celiac education is advisable if they are to play an integral role in helping people with celiac disease to maintain a gluten-free diet. Read more at: Am J Pharm Educ. 2018;82(2)
  3. Celiac.com 08/07/2018 - A new drug designed to reduce symptoms of accidental gluten ingestion in celiac disease sufferers has yielded some encouraging data. The drug in question is a monoclonal antibody designed to reduce adverse reactions in celiacs who are accidentally exposed to gluten. The results, presented at Digestive Disease Week, held in Washington DC from 2–5 June 2018, suggest that monoclonal antibodies could provide protection for people with celiac disease. Celiac patients on a gluten-free diet who randomly received six injections of a monoclonal antibody, called AMG 714, over a ten-week period, enjoyed a substantial reduction in intestinal inflammation. Over a ten week study period, celiac patients on a gluten-free diet received six randomly assigned injections of either a placebo, or of AMG 714 at a dose of either 150mg or 300mg. Patients then underwent a dietary gluten challenge from week through until week twelve. As tested, the drug did not reduce damage to intestinal villi for either treatment group, which was the trial’s primary goal, but it did significantly reduce celiac-related inflammation and symptoms in response to gluten consumption. Patients receiving the highest dose of AMG 714 had no clinically active disease at week twelve of the study, and also had a significant improvement in self-reported outcomes, compared with the placebo group. No matter how diligently people with celiac disease follow a gluten-free diet, they can still suffer accidental gluten exposure ingestion. Treatments like AMG 714 could become important adjunct to gluten-free diet in for people with celiac disease, including non-responsive celiac disease. Read more in Pharmaceutical-journal.com
  4. Celiac.com 06/25/2018 - The latest studies show that celiac disease now affects 1.2% of the population. That’s millions, even tens of millions of people with celiac disease worldwide. The vast majority of these people remain undiagnosed. Many of these people have no clear symptoms. Moreover, even when they do have symptoms, very often those symptoms are atypical, vague, and hard to pin on celiac disease. Here are three ways that you can help your healthcare professionals spot celiac disease, and help to keep celiacs gluten-free: 1) Your regular doctor can help spot celiac disease, even if the symptoms are vague and atypical. Does your doctor know that anemia is one of the most common features of celiac disease? How about neuropathy, another common feature in celiac disease? Do they know that most people diagnosed with celiac disease these days have either no symptoms, or present atypical symptoms that can make diagnosis that much harder? Do they know that a simple blood test or two can provide strong evidence for celiac disease? People who are newly diagnosed with celiac disease are often deficient in calcium, fiber, folate, iron, magnesium, niacin, riboflavin, vitamin B12, vitamin D, and zinc. Deficiencies in copper and vitamin B6 are less common, but still possible. Also, celiac disease is a strong suspect in many patients with unexplained nutritional anemia. Being aware of these vague, confusing symptoms of celiac disease can help people get bette advice, and hopefully speed up a diagnosis. 2) Your dentist can help spot celiac disease Does your dentist realize that dental enamel defects could point to celiac disease? Studies show that dental enamel defects can be a strong indicator of adult celiac disease, even in the absence of physical symptoms. By pointing out dental enamel defects that indicate celiac disease, dentists can play an important role in diagnosing celiac disease. 3) Your pharmacist can help keep you gluten-free Does your pharmacist know which medicines and drugs are gluten-free, and which might contain traces of gluten? Pharmacists can be powerful advocates for patients with celiac disease. They can check ingredients on prescription medications, educate patients to help them make safer choices, and even speak with drug manufacturers on patients’ behalf. Pharmacists can also help with information on the ingredients used to manufacture various vitamins and supplements that might contain wheat. Understanding the many vague, confusing symptoms of celiac disease, and the ways in which various types of health professionals can help, is a powerful tool for helping to diagnose celiac disease, and for managing it in the future. If you are suffering from one or more of these symptoms, and suspect celiac disease, be sure to gather as much information as you can, and to check in with your health professionals as quickly as possible.
  5. Celiac.com 06/11/2018 - Untreated celiac disease causes damage to the small intestine, which can interfere with proper nutrient absorption. Most patients can recover proper nutritional absorption via vitamins and mineral therapy, according to the CDF. Avoiding gluten is key. However, many people with celiac disease may not know that their pharmacist might just be one of their best allies in the fight to avoid gluten. Currently, there are no rules that require drug manufacturers to disclose the source of medication ingredients. Consumers can contact the manufacturer directly with questions, and some drug companies strive for clear, helpful answers, but getting correct information can be challenging. Many times though, an answer won't address possible cross contamination during the manufacturing process. This is where pharmacists can be a strong ally for patients with celiac disease. Here are a few way that pharmacists can help people with celiac disease to avoid hidden gluten in their prescriptions and over-the-counter drugs. The first thing pharmacists can do is to check ingredients on prescription medications these patients are taking. They can also share related information to help educate patients, and to improve their choices, and speak with drug manufacturers on patients’ behalf. In addition to assisting with prescription medicines, pharmacists can offer recommendations on vitamins and supplements. As with prescription drugs, both doctors and patients should do their best to review the ingredients used to manufacture vitamins and supplements, and to share this information with celiac patients. So, if you have celiac disease, definitely consider enlisting your pharmacist in an effort to get complete drug and supplement information. This simple tactic can help you to remain gluten-free during your course of drug treatment, however long that may last? Do you have a story about gluten in prescription drugs or supplements? Do you use your pharmacist to help you better understand your gluten-free drug and supplement options? Share your story with us. Source: medscape.com
  6. Celiac.com 12/20/2017 - The US Food and Drug Administration (FDA) wants drugmakers to provide detailed labeling about gluten in drugs. The agency's recent draft guidance encourages drugmakers to provide clear labeling about whether their product ingredients contain gluten. FDA says the guidance is meant to improve consumer knowledge about the presence of wheat gluten in oral drugs. Unless a drug specifically contains wheat gluten or wheat flour as an ingredient, the agency says it expects most drugs to contain less gluten than a gluten-free cookie. Under the guidance, the "amount of gluten estimated to be potentially present in a unit dose of an oral drug product (less than 0.5mg) is significantly less than the range at which gluten is estimated to be present in a gluten-free diet (5 to 50mg)." The guidance notes that 0.5mg gluten is the high end of its estimated range. FDA also says it is unaware of any currently marketed oral drugs that contain gluten as an intentionally added inactive ingredient, and that drugs that with intentionally added gluten would have to be labeled as such. The guidance encourages manufacturers to include a statement that their drug "contains no ingredient made from a gluten-containing grain (wheat, barley or rye)" when such a statement is "truthful and substantiated" in the description section of the drug's prescribing information. The guidance pertains to all human drugs that pass through the small intestine, including drugs that are taken orally, topical drugs applied on or near the lips and drugs that are applied inside the mouth. The guidance was necessary in part because, according to FDA Commissioner Scott Gottlieb, "because there has been uncertainty about gluten in certain drug products, some patients may be avoiding medications that would otherwise offer a health benefit." Read the full guidance at: FDA.gov
  7. Celiac.com 08/12/2017 - The latest research report from HTF Market Intelligence Consulting is titled "Global Celiac Disease Drugs Market 2017-2021." The report offers detailed information and analysis of the competitive market landscape, forecast and strategies. The report covers geographic analysis that includes regions like Americas, APAC, EMEA, along with important players, including F. Hoffmann-La Roche, Johnson & Johnson, Merck, and Pfizer. It provides information, market insights, future trends and growth prospects for forecast period of 2017-2021. The report presents a detailed picture of the market by way of study, synthesis, and summation of data from multiple sources, and research analysts project the global market for celiac disease drugs to grow at a CAGR of 24.22% during the period through 2021. The primary treatment for celiac disease is still a completely gluten-free diet. There are a small number of anti-inflammatory and immunosuppressant drugs and nutritional supplements that are used as off-label, secondary treatments in celiac disease, but as yet, no drugs approved for primary treatment of celiac disease. Development of such treatments for celiac disease offers huge potential for profit to any company who can get a drug approved for the commercial market. The growth projections attempt to reflect the data behind a fast growing global market. Request a sample report at: htfmarketreport.com
  8. Celiac.com 04/28/2017 - The global market for new drugs to treat celiac disease is set to surge strongly by 2021, according to the latest market report from Persistence Market Research. The company's Celiac Drugs Market report offers in-depth analysis of overall market trends, macro-economic indicators, and governing factors, along with the projected strength of individual market segments. The report also offers geographical breakdowns of the various market factors and the specific market segments they influence. Key factors influencing global market growth of celiac drugs include increased healthcare expenditures, changing lifestyles, growing healthcare awareness, and an increase in incentive by various governments and government associations. However, complex regulatory frameworks govern drug approval in most countries, and could limit or slow the global market growth for celiac drugs. That global celiac drug market is currently dominated by North America, in part due to rising celiac diagnosis, coupled with limited treatment options. In the next five years, the Asia-Pacific region will emerge as a major market for celiac drugs, with China and India seeing the bulk of the growth. Key forces driving the celiac drug market in developing countries include the large pool of patients, increasing awareness about the disease, and rising government funding in the region. Rapid innovation of drugs to effectively treat celiac disease presents tremendous opportunity for the global drug market. The major companies developing celiac drugs for the global market are Alvine Pharmaceuticals, Inc., Alba Therapeutics Corporation, ImmusanT, and the Institute for Protein Design. These are among numerous companies looking to develop, perfect market drugs treatments for celiac disease over the next few years. View more of the report at: PersistenceMarketResearch.com
  9. Yvonne (Vonnie) Mostat

    Did You Know? (Winter 2017)

    Celiac.com 01/11/2017 - Did you know that Advertising has "Cottoned onto us?" In December all the magazines are about baking, foods, cakes and bakes, candies and calories. If you are not aware of what "Cottoned up" actually means, it means that even if we have celiac disease, gluten sensitivity or dermatitis herpetiformis, they know that in December, prior to Christmas, we are geared up to baking tasty, sweet, gluten-free treats. And in January we are into healthy eating, like natural soups, low calorie warm and nutritious eating, cost saving ideas, because we have just gone through Thanksgiving gluttony and Christmas eating. At one time we celiac people did not have the options that we have today. It was white rice bread from the freezer of the store, full of frosty tops, and vague cookies that cost $3.00 each. Now we have so many options we can get fat too, starting with Thanksgiving right up to New Year, when the new magazines come out with calorie cutting ideas, weight loss regimes, and a stringent diet! Did you know that celiac disease affects people differently? According to the The University of Chicago Celiac Disease Center: "There are more than 200 signs and symptoms of celiac disease, yet a significant percentage of people with celiac disease have no symptoms at all. However, people without symptoms are still at risk for some of the complications of celiac disease". For example, my 19 year old grandson's girlfriend has celiac disease, and she likely had it all her life. She was tested for celiac disease because she had "tummy aches before I write exams". That was it! Fortunately she had a bright mother who took her to the doctor and asked for the simple blood test for celiac disease. Sure enough, after doing the blood test and undergoing the biopsy of the jejunum, she had celiac disease. She was not skinny because she was 18 and growing, she was skinny because of malabsorption and eating her daily breakfast of cinnamon toast, and her usual lunch of peanut butter and jelly sandwiches. I am a little wary of the biopsy of the jejunum because as a nurse I found several discrepancies in the testing process. I have seen where a gastroenterologist who did failed to biopsy the correct area and told patients that they were negative for celiac disease. The patients became quite ill and the test was repeated by another gastroenterologist, and the test proved positive for celiac disease. In other words, the two patients did indeed have celiac disease. Did you know that the Head of dermatology at the University of British Columbia recommends Dapsone as the drug of choice for clearing up dermatitis herpetiformis? It is called the “Golden Standard” of treatment, which he teachers to all his students of dermatology. I had three biopsies of the lesions on three different places in my body. It was not until the fourth biopsy that they acquired a Positive for dermatitis herpetiformis. It is very difficult to obtain punch biopsies of the DH. But if they put you on Dapsone for four days the lesions begin to clear up almost immediately. It took longer for the lesions in my scalp to go away, around six month, and four days for those on the other parts of my body to disappear. And they were so itchy (as any of you with DH know) that I actually contemplated cutting all my hair off. I tried Quellada liquid thinking it might be fleas, bed bugs, or some other strange skin disorder. "A little learning is a dangerous thing", that is what they say to all nurses. Those of you who are newly diagnosed with DH and placed on Dapsone, please remind your doctor if he has not already told you that Dapsone can cause anemia. I was advised to take 2,000 Units of Vitamin C daily because it helps significantly with the anemia. According to an article by Lisa Fittterman in the Winter 2016 issue of Allergic Living magazine, a 28 year old California Mom was stymied by her child's reactions and celiac outbreaks because they are so vigilant about reading labels when shopping. The culprit was a new generic controller inhaler for her asthma. The Mom looked up the medication on the Internet and saw the word, "Starch". She says the drug turned out to contain gluten as an additive. She hit roadblocks at every turn. With celiac disease now affecting 1% of the people in North America, "drugs can present a distressing unknown". What is an excipient they ask? Inactive ingredients used as binding agents tent to give bulk and allow them to absorb water and disintegrate. They are derived from foods such as corn, potato or wheat starch. Independent investigations have shown that wheat starch is used less frequently than the other two because it doesn't bind well." When you ingest a new drug without knowing what it contains it is like walking down a road blindfolded says Sue Newell, the Canadian Celiac Association's manager of operations. "We teach people how to read labels and cut through jargon to identify every ingredient - but with prescription drugs they can't do that...they may need to take drugs, but they don't feel safe." The US. Based National Foundation for Celiac Awareness (NCA) released in the Fall of 2014, almost 25 percent of the 5,625 people with celiac disease and gluten sensitivity reported having experienced gluten-related symptoms to medication. Patients and health–care providers said this has led to anxiety and non-compliance in taking drugs. Both Canada and the U.S.A. Food and Drug Administration have national standards of less than 20 parts per million (ppm) of gluten for a packaged food to claim to be gluten-free, but the requirements for food labeling do not apply to prescription or over-the-counter drugs. In May 2015, the FDA denied the request of a citizen's petition to either ban gluten as an inactive drug ingredient or require that its presence be labeled. The FDA said that "No oral-drug product is expected to contain more gluten than the amounts potentially present in foods that can be labeled 'gluten-free' under the FDA's food-labeling regulations." It is far from an official requirement in Canada. The Canadian Food and Drugs Act sets the regulations for labeling gluten and allergens, but the focus has been far more on food. A Health Canada spokesperson says that the 2014 plain-language labeling initiative additionally makes it necessary for pill package inserts to list ingredients. But Newell of the CCA says these listings are not as transparent as they sound. Though the protein is not often present in our medications, the bad news is that finding out for certain may take the skill of a detective or a sleuthing pharmacist. It is time for the celiac and gluten sensitive community, to unite and fight, write letters, speak to their pharmacists and repeat the fact that the person ordering the drug is "A brittle celiac," and all drugs need to be researched by the pharmacist prior to filling prescriptions. Steve Plogsted, a pharmacist with a special interest in tracking gluten, suggests: "Watch for the word 'STARCH' as an excipient on a medicine, as it's the only likely culprit to contain gluten. If the word is there, try to drill down through the manufacturer as to what kind of starch. If it is wheat, you will need to avoid it." One man took a stand for gluten-free drugs. Michael Weber was diagnosed with celiac disease on 2004, and immediately adopted the gluten-free diet to protect his health. BUT, after taking a generic for only a few days, the resident of Eastchester, New York, was distressed to find he was again developing symptoms, such as the dermatitis herpetiformis skin rash he had incurred before the condition was discovered. It turned out the pills contained gluten as an inactive ingredient. Shocked to find this undeclared exposure after he had been so careful, Weber contacted the FDA, but he was informed that the manufacturer wasn't braking any rules by not stating gluten's presence overtly. In 2008, Weber filed a citizen's petition requesting that the FDA either ban gluten outright in medications, or require manufacturers to label for the protein. Then, for seven long years, he got politicians to write letters of support, and made follow-up inquiries, but he received no replies. Finally, in 2016 the U.S. consumer protection group Pullback Citizen filed a lawsuit to elicit a response from the FDA. Last May the agency issued a 21 page decision that denied the request for a ban and stated that manufacturers already needed to identify gluten as an intentionally added inactive ingredient to any drug that is taken orally. The FDA said it did, however, plan to issue "draft guidance" for industry regarding gluten in drug products, but no time-line was given. FDA spokesman Stephen King explained the decision in an interview saying that if people with celiac disease are doing well on a gluten-free diet, they "should" not be harmed by the very low amounts of gluten potentially present in oral drug products. Conversely, if they aren't doing well, "we would expect {them} to consult with [their] physician about ways to further reduce overall exposure to gluten. Such efforts might first focus on the diet as the most significant potential course for oral gluten exposure." But Katie Einspanier, Weber's lawyer through Public Citizen, criticized the ruling as nothing more than a super-technical reading of the petition since the FDA's response focused on the possibility of gluten itself being an inactive ingredient. "The most likely scenario for gluten in drugs is that gluten is simply a natural component of another inactive ingredient and not separately added as an inactive ingredient." Weber is considering whether to draft a new petition with more precise language. We will keep you informed regarding this one man's fight for gluten-free drugs. He needs to be cheered, and we all need to sit down at our computer and help by writing to pharmacists, the FDA, and the College of Pharmacy.
  10. Celiac.com 05/04/2009 - In the rush to vaccinate people in the wake of the latest outbreak of H1N1 "Swine" flu virus, a number of people with celiac disease and gluten intolerance have asked about the gluten-free status of drugs given for the treatment of swine flu. The Centers for Disease Control and Prevention (CDC) website has a page dedicated to antiviral medicines and swine influenza. That website contains the following information: To treat H1N1/swine flu, or prevent the flu in people one year of age or older who have been exposed to the virus, the CDC recommends oseltamivir (Tamiflu®). When contacted, Roche representatives stated that all Roche products, including Tamiflu, are gluten-free. To treat H1N1/swine flu infection in people 7 years of age and older, or to prevent infection in people 5 years and older, the CDC recommends zanamivir (Relenza®). When contacted, GSK representatives stated that gluten is not one of the active or inactive ingredients in Relenza, but that GSK cannot guarantee that the product is free from potential cross-contamination. Please be aware that this information applies only to products available in the U.S. For drugs obtained internationally, contact the manufacturers directly. Resources: Zanamivir (Relenza) Glaxo Smith Kline (888) 825-5249 Oseltamivir (Tamiflu) Roche Pharmaceuticals (800) 526-6367 Source: Nancy Lapid, About.com Guide to Celiac Disease
  11. I am going for surgery. The surgeon told me he prescribes hydromorphone post operation. Do i need to worry about gluten? How about Tylenol 3 (maybe I can ask for that instead). Thanks, DougE
  12. Celiac.com 05/12/2015 - The current treatment for celiac disease is the avoidance of gluten-containing foods, beverages, and other products by means of a strict gluten-free diet. Following such a diet can be challenging, but recent FDA labeling rules go a long way toward helping people with celiac disease know with pretty good certainty whether a food product contains gluten, or is gluten-free. However, When it comes to prescription drugs, medicines, OTC products, supplements, and vitamins, people with celiac disease currently have little guidance. The FDA rules that mandate the labeling of gluten and other known allergens on food product labels does not apply beyond food. There are currently no rules mandating the labeling of gluten in drugs and medicines. That means that your average person with celiac disease might have a hard time finding out which medications, OTC products, supplements, and vitamins may contain gluten, and may experience adverse symptoms from continued gluten ingestion. A team of researchers set out to assess the role of pharmacists in educating patients and evaluating their medication use to ensure the optimal management of celiac disease. The research team included Ashley N. Johnson, PharmD, BCPS, Angela N. Skaff, BS, PharmD Candidate, and Lauren Senesac, PharmD. They are affiliated with the Pharmacy Practice Drug Information Center, and the Lloyd L. Gregory School of Pharmacy Palm Beach Atlantic University West Palm Beach, Florida. The team celiac disease review included Etiology and Risk Factors, Clinical Presentation and Diagnosis, Factors That May Impair Drug Absorption, Legislation, Management, and Resources. They found that pharmacists do indeed have an essential role to play in educating patients and evaluating their medication use to ensure the optimal management of celiac disease. This often can be accomplished by evaluating the ingredient list, contacting the manufacturer, or utilizing a variety of other resources. Gluten can potentially be introduced and contaminate otherwise gluten-free products during the manufacturing process, although the likelihood is low. Key points to consider are that even if a brand product is confirmed to be gluten-free, it cannot be assumed that the generic version is also gluten-free, and that if a product has a new formulation, appearance, or manufacturer, it is prudent to reassess it and confirm that it remains gluten-free. When evaluating the gluten content of prescription and OTC products, it should be remembered that gluten can be masked in an excipient. Starches used as excipients in pharmaceutical products are often derived from rice, potato, or tapioca, which are gluten-free. However, if the source of the starch is not explicitly stated, the excipients may contain gluten. Sources of excipients that contain gluten include barley, farina, kamut, rye, spelt, triticale, and wheat. Pharmacists play a pivotal role in educating patients about gluten-containing foods, medications, and supplements in order to help them adhere to a GFD and in ensuring that patients receive additional follow-up care, if needed. Source: US Pharmacist. 2014;39(12):44-48.
  13. Celiac.com 05/06/2015 - Gluten is a common ingredient in many commercial food products. Less commonly known, however, is that many manufacturers use gluten as an inert ingredient in such products as medications, supplements, and vitamins. For people with celiac disease, exposure to as little as 30 to 50 mg of gluten per day can damage the mucosa of the small intestine. So, it is important to know the gluten content of prescription and nonprescription medications, even though a lack of labeling laws can make it challenging to find products that are gluten-free. Given the lack of resources to verify the gluten content of prescription and non-prescription medications, it is best to check with the manufacturer. Your pharmacist can help make the process a bit simpler than doing it yourself. There are three things you and/or your pharmacist can do to determine the gluten status of any prescription drug. First is the use of a package insert (PI). You or your pharmacist can use the PI to review drug formulations, and find contact information for pharmaceutical manufacturers. Gluten is used in numerous medications, supplements, and vitamins, often as an inert ingredient known as an excipient. For prescription medications, the PI should include a detailed listing of excipients; however, if this information is not readily available, the FDA provides drug labeling information for prescription and some OTC medications at DailyMed (dailymed.nlm.nih.gov). For non-prescription products, there often is nothing in the PI regarding gluten content, which means you will likely need to check with the manufacturer to be sure. Second, you or your pharmacist can visit company websites to help determine whether a medication potentially contains gluten. Third, you can find manufacturer contact information on the product or its packaging, by conducting an Internet search using the manufacturer's name, or by accessing online drug-information resources such as Clinical Pharmacology, Facts & Comparisons, and Martindale. When requesting information from a manufacturer, it is helpful to provide the lot number. Recent research by Mangione and colleagues showed that information about the gluten content of non-prescription products is usually available and easy to access through the manufacturer. Fourth, there are some third-party websites, such as GlutenFreeDrugs.com, which is maintained by a clinical pharmacist, contains a detailed chart listing selected brand and generic medications that are gluten-free, as well as those free of lactose or soy. However, this is not a comprehensive or definitive list of products, as ingredients and formulations can change from lot to lot in the manufacturing process. Lastly, Celiac.org, the Celiac Disease Foundation offers a variety of resources and provides information on the treatment of celiac disease, tips on living gluten-free, and support-group contact information. Source: US Pharmacist. 2014;39(12):44-48.
  14. Celiac.com 12/16/2014 - Will people with celiac disease spend money on drugs designed to reduce or eliminate adverse reactions to gluten? Drug researchers and investors are betting they will. Currently, the only proven treatment for celiac disease is a strict gluten-free diet. However, a number of companies are looking to debut drugs for treating celiac disease in the next five years, With that in mind, Abhilok Garg, Ph.D., an immunology analyst with research and consulting firm GlobalData, is projecting sales such drugs in the US and five major European markets Germany, France, Spain, Italy and the UK, to reach approximately $551.1 million by 2023. The launches of Alba/Teva’s larazotide acetate, Alvine/AbbVie’s latiglutenase, and BioLineRX’s BL-7010 portend a new world of therapies for the estimated 600,000 diagnosed celiac patients in these countries. With early trials looking promising and no obvious problems on the horizon, analysts expect larazotide acetate to enter the US and 5EU markets in Q1 2018 and Q1 2019, respectively, followed by latiglutenase in Q1 2019 and Q1 2020. Latiglutenase is currently being developed as a chronic drug treatment, GlobalData’s interviews with KOLs have indicated that clinical experience with this drug could dictate the way it is prescribed to patients, and that it may in some cases be used as an “on demand” treatment,” says Dr. Garg. Larazotide acetate works by modulating tight junctions (TJs) in the small bowel epithelium, and has tried to maximize recent research showing that people with celiac disease do have altered intracellular spaces and TJ structures in the lower esophagus. BL-7010 works by sequestering gliadins, effectively masking them from enzymatic degradation and preventing the formation of immunogenic peptides that trigger an adverse immune reaction when people with celiac disease consume wheat. BL-7010 has cleared early trial hurdles and been found to be safe and well tolerated in both single and repeated-dose administrations. Does the idea of a reliable treatment for celiac disease appeal to you? Would you try such drugs, or just stick with the gluten-free diet? Source: Pharmabiz.com
  15. Celiac.com 04/18/2015 - Research is underway on a number of new drugs intended to celiac disease treatment beyond a simple gluten-free diet. However, even though several drugs are in Phase 2 trials and results appear promising, discussion around regulatory endpoints is just beginning. A research team recently reviewed endpoints for Phase 2 and 3 trials of new celiac disease drugs currently under development, and detailed their results in a scientific paper. The team included Klaus Gottlieb, Jill Dawson, Fez Hussain and Joseph A. Murray. They are variously affiliated with the department of Immunology and Internal Medicine of Medical Strategy & Science, Quintiles, Durham, NC, USA, with Corporate Communications, Quintiles, Durham, NC, USA, and with the Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA. In the paper, the team discusses celiac drugs currently under development, along with trial endpoints, such as patient-reported outcomes, histology, serology, gene expression analysis and other tests. They outline the differing requirements for proof-of-concept Phase 2 trials and Phase 3 registration trials, with a particular emphasis on current thinking in regulatory agencies. They conclude their paper with recommendations and a glossary of regulatory terms, to enable readers who are less familiar with regulatory language to take maximum advantage of this review. Stay tuned for more news and information on all developments concerning trials of new celiac drug treatments. Source: Gastroenterology Report, Oxford Journals. 10.1093/gastro/gov006
  16. This is my first post, so please forgive me if I'm in the wrong spot. I've searched extensively and have not been able to find and answer so I'm hopeful that this isn't a repeat question! I was diagnosed with Celiac seven years ago and have been careful to stick to my gluten-free diet throughout that time. My symptoms at the time of diagnosis were all stomach/gastro related, and I had bouts of skin problems growing up as well. I am lucky to have minimal gastro issues now, but the past 12-18 months I've been suffering from a lot of mental health & skin issues. I have been on and off antidepressants in the past, so I never really considered the two could be related until a few months ago, when I was given a gluten filled roll by mistake. I was so depressed I couldn't get out of bed or stop crying and it set off a lightbulb for me. I've ALWAYS been plagued by the brain fog which I attritbuted to too much/too little sleep. I have also been struggling with a reocurring patchy rash/eczema type thing on my lips and chin. I have been extremely careful lately, using only gluten free lotions, shampoo, facewash, toothpaste, etc. I have been feeling a lot better and the rash was going away until this morning. I tried to think of what I did yesterday differently and there are two possibilities. 1. I took my generic klonopin. It's called Clonazepam and the manufacturer is Teva Generics. I can't find it on any gluten free lists, and on their website they so helpfully guide patients to not take the drug if they are allergic to any ingredients, but don't list the actual ingredients. Perfect. I tried to call, but since it's the hoildays their office has been closed. Has anyone had any experience with this particular make? 2. I wore a little bit of makeup yesterday. I have thoroughly checked all of my makeup and gotten rid of anything obvious (the mascara I've been using for YEARS has wheat in it. Whoops.) but most of my makeup does have tocopheryl acetate which I'm learning COULD be an issue. I am using Laura Mercier tinted moisturizer and Tarte concealer. I've read conflicting reviews online (Tarte is gluten free! No, it's not! Etc.) Honestly, I'm at a complete loss. My pharmacy knows I have Celiac and I often ask about gluten content in medications when they're knew so I'm going to be really pissed if they're just ignoring this while dolling out drugs. I'm also very into makeup, and having to switch to entirely all natural brands is going to be really depressing for me, and I'd love to avoid it if possible. So basically this is a long winded rant/complaint combined with a question: does anyone have any insight on gluten in generic Clonazepam and or/ the two makeup items listed above? Thank you so much in advance.
  17. GlutenFreeInSC

    Gluten They Are Missing In Drugs!

    Soooooo, how many of you realized that Sodium Starch Glycolate (a common filler in EVERYTHING) is considered gluten and toxic to those of us who have severe Celiac? I learned the hard way..... After being bitten by what they think was a deer tick (had a round bullseye rash) I was put on what was supposed to be a gluten free drug. I was SICKER after taking the drug...dawned on me I had better research the filler ingredients. Turns out to those very sensitive, SODIUM STARCH GLYCOLATE is in the same family as gluten and cannot be tolerated. Now.....go to www.glutenfreedrugs.com and they list SO many drugs that indeed CONTAIN this hidden gluten! I have been getting sick and not understanding why.....now I know. Please let everyone know about this hidden substance that should be included in the GLUTEN TOXIC SUBSTANCES that make us so very sick
  18. Celiac.com 02/20/2012 - The U.S. Food and Drug Administration (FDA) is gathering information on drug ingredients derived from wheat, rye or barley, to help people with celiac disease make better-informed decisions when buying drugs and other health products. Specifically, the FDA is asking pharmaceutical companies for information about any ingredients derived from wheat, rye or barley, that are used to make U.S. products. Additionally, the FDA is seeking information about the prevalence of such ingredients, processing steps taken or possible to remove gluten, and any current gluten testing practices. The FDA is also seeking to understand exactly how crucial ingredients derived from wheat, rye and barley are to the production of any given drug that may contain them, and to press for possible substitutes. Lastly, the FDA wants to make certain that people with gluten sensitivities get complete information when receiving drugs in a clinical setting. Overall, the FDA seems to be making certain that the known allergens in wheat, rye and barley are getting proper attention from drug manufacturers. Stay tuned for the results, and for information on how these FDA actions impact gluten-free issues regarding drugs, health and medical products in the future. Source: http://www.in-pharmatechnologist.com/Materials-Formulation/FDA-researching-gluten-in-drugs-to-help-celiac-disease-patients
  19. Celiac.com 02/06/2009 - Have you, as a Celiac, ever suspected that the medicine you were taking was making you sick? It could be because that pill or capsule was made with gluten. That’s because the U.S. Food and Drug Administration (FDA) allows pharmaceutical companies to use wheat gluten, a large protein that celiacs can’t eat, to be used as a mixing agent in drugs. Drug companies use chemical agents called excipients as inert additives to mix and bind the actual active ingredient of a drug so that you can take it in the form of a conveniently sized pill. Currently gluten is on the list of permitted excipients that you might be taking without even knowing it. That’s why I have petitioned the FDA to get gluten out of medicine. In a constitutionally protected act, I have submitted a Citizen’s Petition to the FDA requesting that they take gluten off of their list of permitted excipients. As I write, the National Foundation for Celiac Awareness has asked the FDA only to label medicines that contain gluten, but this approach will continue to allow gluten to be used at the decision of the manufacturer. The FDA has a decision to make. I believe that they should follow existing law and recognize that gluten is toxic to a significant segment of the population. If the FDA got gluten out of medicine it would mean that you could confidently take aspirin, any generic, or any othe drug whether prescribed or over the counter, and not have to worry about gluten—and that would be true for all drugs. It would not, however, mean that the supplements you were taking would be gluten-free, because supplements aren’t regulated like drugs, but are regulared like food. As you probably know, foods will soon be labeled according to a federal gluten-free standard. But only some food makers will decide to make the products that will be labeled gluten-free. And the same thing might happen to drugs, if the FDA decides it is sufficient only to extend the labeling standard to drugs. As a Celiac, you won’t be able to take a drug unless it says gluten-free, because if doesn’t say gluten-free, who knows what’s inside? Is that Tylenol OK for you? Or how about that generic heart medication you get in the mail? The reality is that some day soon, the FDA might allow pharmaceutical companies to make business decisions on whether or not you can take a necessary medication. Taking medicine isn’t a matter of personal choice like foods. Rather, a doctor might not be able to give you a prescription because it might contain gluten. Maybe there won't be an equivalent drug that is also gluten-free. Time to Take Action! There is, however, something you can do. I petitioned the FDA to get gluten gone for good. I asked my congresswoman to write a letter to the FDA highlighting her concern about my petition. And any citizen can comment to the FDA about my petition, for or against. You can ask your congressman to pay attention to the decision, which the FDA is about to make. Now that I’ve wound you all up, here is how to contact the FDA. Go on the internet and surf to www.regulations.gov and enter the Docket number of my petition, 2008-P-0333, which you might enjoy reading. My petition is called Michael Weber of New York State. Highlight the line for comments of submissions, and then tell them what you think and who you are. Tell the FDA why you think there shouldn’t be any gluten in your medicine—please do it now!
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