Gluten in Medication: Understanding the Risks and Protecting Yourself
By Audrey Scagnelli, Delight Editorial Assistant
The risk of consuming gluten does not stop with food; gluten can be found in everyday medication as well. Unfortunately, there are few to no disclosure requirements forcing drug manufacturers to label medicine as containing gluten, a fact which ultimately means that celiac patients, physicians, and pharmacists end up working with drug manufacturers for hours in search of the answer to the question, Does this drug contain gluten?
The primary problem? One month a drug may contain gluten, and the next it may be gluten-free: there is no constant in terms of the presence of gluten in medication.
In its most common form, gluten makes its way into medicine by being used as an excipient, or filler, which binds the drug together, provides bulk and shape, or aids in digestion of the pill or tablet. It is important to understand that excipients are inactive ingredients; they serve a purpose, but it is the active ingredient that has the medicinal effect. Fillers are made from many starch sources, including potatoes, corn, tapioca, and wheat. In addition, the risk of cross-contamination is also a concern, even in cases in which no gluten exists in the excipients: pharmaceutical companies buy excipients in large batches from third-party manufacturers who will not verify whether there has been gluten exposure. As a result, the pharmaceutical companies refuse to guarantee that there was no exposure to gluten during the production process.
Since the Food and Drug Administration does not require companies to disclose the botanical source of the starch, which would force manufacturers to label starch as “cornstarch” or “potato starch,” for instance, it is close to impossible to find out what kind of starch is in a particular medicine. In fact, under current FDA standards, there is no requirement for any inactive ingredient in medication to be sourced.
Gerry McEvoy of the American Society of Health System Pharmacists says, “The first step and the simplest step [toward addressing standardization of medication regarding gluten] would be an enforcement of proper labeling.” He goes on to say that uncontaminated cornstarch, which poses no risk, is the most common starch used in medicine, but that “it’s difficult to provide assurance that the drug product doesn’t provide a risk to those with an intolerance.”
It is important to note that generic versions of a drug may contain varying excipients; thus, though one version does not contain gluten, there is no guarantee that another is also gluten-free. Labeling the botanical source of starch would go a long way toward helping celiac patients manage medication, though it would not eliminate contamination concerns.
Alarmingly, as reported by Steve Plogsted (a clinical pharmacist at Nationwide Children’s Hospital in Columbus, Ohio), “some drug companies have been telling people that some of the drugs that they manufacture contain gluten. When I investigated their claims, it appeared that the reason they are blatantly claiming that their drugs are contaminated is that they have used a sugar alcohol as an excipient.” Such incidents simply raise concerns about labeling and about accuracy regarding the presence (or absence) of gluten. Sugar alcohols are, in fact, carbohydrates and are naturally found in numerous fruits and vegetables. They may also be extracted from various sources that include starch, such as wheat.
Plogsted explains, however, that “during the manufacturing process, [sugar alcohols] are completely refined, leaving behind no gluten proteins,” comparing the process to making table sugar. His website, www.glutenfreedrugs.com, reports that the two most commonly used sugar alcohols in prescription drugs are mannitol and xylitol, which are used as sweeteners in liquid drugs or as bulking agents. As cited by the Gluten Intolerance Group of North America, these ingredients are considered safe for celiac patients to consume.
Plogsted notes that sugar alcohols are naturally found in many everyday food items and cautions that they are likely, if consumed in significant quantities, to cause in the non-celiac gastrointestinal disturbances and diarrhea, mimicking the symptoms of celiac patients if exposed to gluten.
Crucially, Plogsted states, “You’re less likely to be exposed to gluten if you have a liquid medication. I don’t know of any liquids that have a starch in them; however, liquids are less portable, and a lot more expensive, and there are a whole lot fewer choices.” It must be noted that, though liquid medications are greatly beneficial to the celiac, they are both harder to manufacture and often less stable than the pill version of the medicine.
Plogsted has been leading the effort to ensure the disclosure of gluten in medication for over a decade. His website, www.glutenfreedrugs.com, is used as a primary resource for the National Foundation for Celiac Awareness and the American Society of Health-System Pharmacists. On the website, Plogsted provides an up-to-date list of drugs that are gluten-free as well as a list of those that contain gluten.
Plogsted suggests contacting drug companies that claim their products contain gluten and finding out which excipient the medication contains. If they respond with “sugar alcohols,” he and many others believe the given medications are likely safe to consume. That being said, it is ultimately up to the patient to decide if the drug poses a risk to them.
The Bottom Line:
Many consider the real issue to be the lack of strong proof of what risks are really carried by medications that contain gluten-bearing excipients, since the quantity of gluten in the medicine is so small. McEvoy says, “the FDA is underfunded as it is, and they’d need clear evidence to enforce new labeling laws; that evidence is tough to provide.” In order to present clear data suggesting gluten in medication is harmful, a very isolated and controlled study would have to occur, and that, of course, would require extensive funding.
Nevertheless, today there are numerous ways to keep track of medication and stay healthy and gluten-free. Delight Gluten-Free Magazine has compiled its own guide about what you can do to best keep track of your own medication.
o When purchasing medication, always look on the label for starch.
o Verify that the starch is a gluten-free ingredient.
o Remember that drugs are frequently reformulated, so check the starch often if you routinely refill prescriptions.
o Opt for the liquid form of medication whenever possible.
o Maintain a good, open relationship with your pharmacist and physician.
o Pharmacists are often happy to help read a drug’s list of ingredients and can help contact the manufacturer.
o Use www.glutenfreedrugs.com