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A gluten-free drug problem

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Patients worry about whether their medications are safe on the gluten-free diet

By Amy Ratner, Medical and Science News Analyst

Celiac disease patients continue to worry significantly about the risk of gluten in medications, a study presented at Digestive Disease Week (DDW) found.  Meanwhile, it’s a lesser concern for those who are gluten sensitive.

Both groups follow the gluten-free diet, but 54 percent of those in the study who have celiac disease reported always checking their medication for gluten-containing ingredients, compared to 44 percent of those with gluten sensitivity. Fifty two percent of study participants who have dermatitis herpetiformis (DH), the skin manifestation of celiac disease, said they always check, too.

DH patients reported having reactions to gluten in medication more often than the other two groups, at 54 percent compared to 43 percent for those who are gluten sensitive and 38 percent of celiac disease patients.

Checking and re-checking

The concern about gluten in over-the-counter and prescription medicines was also reflected in the number of ways study participants said they investigate the drugs they take. Sixty two percent of celiac disease patients said they check in two to four ways, compared to 64 percent for DH patients and 51 percent for those with gluten sensitivity.

Patients reported asking the pharmacist and prescribing doctor, checking product labels and inserts, contacting the drug manufacturer, checking drug company websites and contacting celiac disease patient advocacy groups as ways in which they monitor their medications.

Determining the gluten-free status of medications can be particularly tricky. Though most drugs are gluten-free, it’s difficult for patients to verify when that’s the case, creating fear about medications overall. Additionally, there’s debate about whether the small amount of gluten found in some medications is sufficient to trigger the autoimmune response seen in celiac disease.

Gluten-free claims on packaged foods and supplements are regulated by the U.S. Food and Drug Administration (FDA), and an allergen labeling law requires that wheat always be listed on the label of a food product in which it is used. Similar laws don’t exist for labeling gluten in medications, although a proposed bill was reintroduced to Congress in September 2015.

Inactive but worrisome

Although the active ingredient in medications does not pose a risk, inactive ingredients, usually starches that bind a pill together and help deliver the medication to the patient, can contain gluten. Inactive ingredients for the same medication can vary by manufacturer. Different ingredients may also be used if the medication is generic.

Since patients cannot rely on labels for ingredients information, they are sent on a hunt to find out what’s in the particular pill they take. The search has to be started all over if the brand changes or a switch is made to the generic product. Drug companies often give vague or confusing answers when asked about the gluten-free status of a drug.  

The study presented at DDW was conducted by Rok Seon Choung, M.D., of the division of gastroenterology and hepatology at the Mayo Clinic, and Joseph Murray, M.D., director of the celiac disease program there, and colleagues and was funded by an FDA grant to Beyond Celiac.

More than 5,500 patients responded to a questionnaire about gluten in drugs that was distributed by Beyond Celiac and other advocacy groups. Overall, nearly 2,000 said they have experienced a reaction to gluten in medication.

The constant vigilance required to determine if medications are gluten-free adds to the burden of following the gluten-free diet, which is the only treatment for celiac disease, the study concluded.

In addition to research efforts, Beyond Celiac has been involved in the fight to get Congress to pass legislation to improve medication labeling.

You can keep up with developments related to better labeling of gluten in drugs and other research news by signing up for our Research Opt-In here.

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