Getting past the hype of gluten in medication, how real are the concerns, and will there ever be clear labeling?
HER family had been so careful to be gluten-free, but three years after little Aeverie Labile was diagnosed with celiac disease, she was experiencing the same debilitating symptoms all over again. There were the abdominal pains, the bloody diarrhea and migraines. Stephanie Labile would find her then 5-year-old lying quietly on her bed, stoic. Her eyes were closed and her hands cradled her skull. “Mommy, it hurts,” was all she could say.
Labile was worried and at a loss. Her daughter’s gluten-free diet had been working up until this point; if this was gluten again, just how was Aeverie getting exposed?
The California mom and her husband were long familiar with how to read labels closely on packaged foods and schooled in the dangers of cross-contact with gluten. They were well aware that for someone with celiac disease, this protein creates havoc, damaging the villi, tiny projections in the lining of the small intestine that are vital to the absorption of nutrients that affect everything from a child’s growth to bone development and the onset of other serious conditions.
The couple was also used to being forthright in their questioning of doctors since, in addition to celiac disease, their daughter has asthma and severe allergies to foods including nuts, dairy and seafood.
The reappearance of Aeverie’s symptoms was confounding. Then it dawned on Labile: what about medications? The symptoms had resurfaced right around the time Aeverie had begun using a new generic controller inhaler for her asthma. Labile looked up the medication’s ingredients on the Internet and saw the word, ‘starch’. She says the drug turned out to contain gluten as an additive – and so began her odyssey into the world of pharmaceutical non-medicinal ingredients, where roadblocks hampered her search for information at every turn.
“It’s not like I want to know what is in a drug for convenience,” she says angrily. “This is about my child’s life – and I’ll do anything to protect it.”
What’s in a Prescription Pill?
Labile is far from alone in her frustration and fear. Prescription drugs may help relieve aches, clear up symptoms and infections, but for people with celiac disease – the autoimmune disease affecting 1 percent of North Americans – drugs can present a distressing unknown. That’s because, unlike packaged foods, there is no official U.S. regulation to label non-medicinal ingredients for gluten content.
Patients find it difficult to discover whether excipients – inactive ingredients such as binding agents added to give pills bulk and allow them to absorb water and disintegrate – 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 as well.
But ingesting a drug without knowing what is in it is like walking down a road blindfolded, says Sue Newell, the manager of operations for the Canadian Celiac Association. “We teach people how to read labels and cut through jargon to identify every ingredient – but with prescription drugs, they can’t do that,” she says. “They may need to take drugs, but they don’t feel safe.”
That lack of confidence about safety was on display in the results of a national online survey on gluten in medication that the Beyond Celiac organization released in the autumn of 2014. Almost 25 percent of the 5,623 individuals with celiac disease and gluten sensitivity reported having gluten-related symptoms to prescription medication. Both patients and health-care providers said this led to anxiety and non-compliance in taking drugs.
The U.S. Food and Drug Administration brought in the national standard of less than 20 parts per million of gluten for a food to qualify as gluten-free in 2014. But the regulator doesn’t appear to find the same need in relation to prescription or over-the- counter drugs.
FDA: Rare for Drug to Contain Gluten
In 2015, the FDA denied the request of a New York resident’s citizen petition that called for the banning of gluten as an inactive drug ingredient or, failing that, that the protein’s presence be labeled. The FDA replied that while there wouldn’t be new drug labeling regulations, it does “intend to issue guidance broadly addressing the potential presence of gluten in drug products.” The agency noted it was rare for oral drugs to contain wheat, and further 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 FDA’s food-labeling regulations.”
Allergic Living asked the FDA to elaborate on this response. “The petition seemed to be based, in part, on a misconception that wheat gluten is commonly added to drug products as an ingredient and yet does not appear in a drug’s labeled list of ingredients when it has been added,” said agency spokesman Stephen King. “The direct addition of wheat gluten to oral drug products, prescription or over-the-counter, as an inactive ingredient is extremely rare [and] we would expect any oral drug product containing *wheat gluten as an added ingredient to be labeled as containing wheat gluten.”
An expectation, though, is far from an official requirement. And while Beyond Celiac’s full “Gluten in Medication Research Report” found few instances of significant levels of gluten in medication, it was by no means comprehensive. Other studies are scant, the report noted, and it concluded more research was definitely needed.
Several issues of concern include that there is no defined safe threshold for gluten in medication for those with celiac disease, manufacturers often change inactive ingredients, and that celiac patients are reporting symptoms that aren’t consistent “with drug side effects. When it comes to gluten in medication, the more assuring news is that the protein isn’t often present. The bad news, however, is that finding out for certain if there is gluten in medication may take the skill of a detective – or a sleuthing pharmacist.
Investigating Gluten in Medication
MEET Steve Plogsted, a clinical pharmacist at Columbus Children’s Hospital in Ohio who is plainspoken and passionate about both finding gluten wherever it lurks in prescription medications and calming patients’ fears that they will unintentionally ingest the protein. He has been doing this since the early nineties when he was covering the hospital’s GI service. In 1995, he was asked to give a speech to health professionals about the topic. “At the end of the talk, I suggested people call me if they had questions and boy, did I get calls,” he says.
In order to fill a consumer information void, Plogsted researched extensively, then built a comprehensive website dedicated to the issue of gluten in medication and drugs. As more and more people were diagnosed with the autoimmune condition, he found himself fielding smarter questions just as the pharmaceutical firms became – and continue to be – more cautious in their responses.
“You call a drug company to ask if their product contains gluten and they don’t give you the answer you want, which is a simple ‘yes’ or ‘no,”’ he says. “Most of them are wishy-washy.”
This is evident when you peruse a list Plogsted maintains and regularly updates on his website of nearly 500 name-brand medications at Glutenfreedrugs.com. Although only 11 drugs on his list do definitively contain the protein, manufacturers often refuse to guarantee a product’s gluten-free status, since most don’t test for the protein before sending a product to market. Companies may say that an inactive ingredient is “derived from a wheat source,” but Plogsted says that, in most cases, they are referring to highly processed sugar alcohols, or polyols, which contain no wheat gluten.
For instance, on the website for Advil gel caps, “it will tell you they are contaminated with gluten because the gel contains a sugar alcohol, even though by the time they finish the process, the alcohol no longer contains a protein,” the pharmacist says.
“Most experts consider such alcohols safe for people with celiac disease.” But most celiac patients will just hear “wheat” and presume avoidance is needed. Sugar alcohols include ingredients such as mannitol, maltitol, sorbitol, sorbitan, lactitol and xylitol.
Plogsted also recalls the time a manufacturer of gummy vitamins informed him that its product contained “gluten” because corn syrup was an inactive ingredient. Yet “corn gluten” is not the same as the gluten in wheat, barley and rye products, which affects people with celiac disease and gluten sensitivities.
“Their approach is that ‘gluten is gluten is gluten,’ but it’s not,” he says. A big part of the problem, he continues, is that even though the FDA strictly regulates the safe manufacture of drug products, there is no oversight of inactive ingredients, except that only those approved by the FDA in general can be used.
“All this makes it hard for consumers to make decisions,” he says. “Sure, if you have a product that contains no starch, the chances of it having gluten are about as likely as you and me getting married at 6 o’clock tonight. But try telling that to patients. It’s frustrating, but the vast majority of companies don’t care.”
In Canada, meantime, 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 a 2014 plain-language labeling initiative additionally makes it necessary for pill package inserts to list ingredients.
But Newell of the CCA says the Canadian listings are not as transparent as they sound. Unlike with food products, terms like “gluten source” or “allergen” aren’t required to be spelled out. “The non-medicinal ingredient list includes a number of problem ingredient names like ‘pregelatizined starch’ that can be made from wheat,” she says. Once again, the consumer is left in the dark.
What Can Gluten-free Patients Do?
So where do people with celiac disease go from here? How can they trust what they’re ingesting, sometimes daily, to treat another condition?
Plogsted’s advice to consumers who must avoid gluten is to watch for that 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’s wheat, you’ll need to avoid.
On the legislative front, celiac groups showed support for Congressional representatives Tim Ryan and Nita Lowey when, in the fall of 2015, they introduced the Gluten in Medicine Identification Act. It would require drugs for humans to have labels that clearly disclose ingredients that contain gluten.
“People need to be able to trust that the medicine they are prescribed will improve their health, not worsen it,” Ryan said. “Celiac disease is a growing issue in our country and those suffering have the right to know if their medicine contains ingredients that are adverse to their health.”
As well, Nancy Ginter, Beyond Celiac’s director of administration, says there is a need for more research. The organization’s study, which got funding from the FDA, was only meant to determine if there was any credibility to anecdotal reports from patients and health-care professionals that prescription and over-the-counter drugs do cause problems for those on a medically necessary gluten-free diet.
And they do, perhaps mostly related to the avoidance of helpful drugs because of the lack of transparency about gluten in medication. The researchers found that when the gluten content of a medication is unknown, the celiac patient’s health-care team must speculate about the cause of an adverse event, and in an attempt to find solutions, may unnecessarily switch to a less effective medication regimen. Individual consumers may also discontinue the use of a needed non-prescription medication because they suspect the presence of gluten.
As with food products, those following this issue say that a safe threshold for trace amounts of gluten in medication needs to be established, one that factors in the need to take pills on a recurring basis and employs a consistent testing methodology.
“Even if the quantity of gluten and the actual risk are small, patients can have substantial fear or anxiety. This can, and does, alter behavior and lead to them not taking the medication at all. This is unacceptable,” Ginter says. “It’s a problem we can solve. Our goal is to have gluten labels on both prescription and over the counter drugs.”
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