Which pharmaceutical drugs, including vitamins and medications like sevelamer (phosphate binder), dexamethasone (corticosteroid), and prednisone (corticosteroid), contain gluten?

Pharmaceutical Drugs Containing Gluten: Concerns for Celiac Disease Patients

Several pharmaceutical drugs contain ingredients derived from gluten sources, including starch-based excipients, dextrins, and other wheat-derived components that pose risks to patients with celiac disease. 1

Problematic Ingredients in Medications

• Starch - Source must be known; gluten-free if from corn or potato starch, but not gluten-free if from wheat 1
• Dextrimaltose - Not safe as it is made from wheat 1
• Flour, gluten, dusting powder - Safety of drugs with wheat starch is questionable 1
• Malt and malt syrup - Source must be known to determine gluten content 1
• Dextrin, dextrates, cyclodextrins - Processed by enzymatic action of barley malt or corn flour 1
• Maltodextrin - Source must be known to determine gluten content 1
• Sodium starch glycolate (carboxymethyl starch) - Generally not gluten-free 1
• Caramel color - Derived from barley and used in production of other ingredients 1
• Alcohol (distilled ethanol) - Source must be known 1

Specific Medications of Concern

Sevelamer (Phosphate Binder)

• Contains inactive ingredients including lactose monohydrate and sodium starch glycolate 2
• Sodium starch glycolate is generally not gluten-free according to gastroenterology guidelines 1
• May interfere with normal fat absorption and reduce absorption of fat-soluble vitamins A, D, and K 2

Prednisone (Corticosteroid)

• Contains lactose monohydrate, pregelatinized starch, and sodium starch glycolate in various strengths 3
• Pregelatinized starch is gluten-free only if made from corn, rice, tapioca, or potato 1
• Sodium starch glycolate is generally not gluten-free 1

Vitamins and Supplements

• Vitamin and mineral supplements must be verified for gluten-free status 1
• Herbal medications and nutritional supplements are particularly concerning as they are not regulated and may contain undisclosed gluten sources 1
• Many supplements fail to specify the name or origin of all ingredients 4

Clinical Implications and Recommendations

• Problems with medications are generally caused by the source of inactive ingredients and are of concern in oral medications 1
• Patients with celiac disease are at risk of acute illness if they are treated with products containing gluten 5
• The responsibility for safety of medications and supplements starts with the ordering physician 1

Best Practices for Prescribers

• Add a statement such as "As ordered if gluten-free or provide a gluten-free equivalent" to prescriptions, which obligates the pharmacist to verify medication safety 1
• Avoid generic substitutions, whose sources could change frequently 1
• Be aware that FDA regulations for ingredients differ between medications and foods 1

Challenges in Identifying Gluten-Free Medications

• There is currently a global trade in medicines, and patients and healthcare providers often don't know whether a product is gluten-free unless specifically labeled 6
• Wide variability exists between countries on provided information and labeling of gluten-containing medicines 7
• Many pharmaceutical products that claim to be "gluten-free" have not been demonstrated to digest the toxic epitopes of gluten 4

Future Directions

• All drug products can be made gluten-free as there are many alternatives to gluten-containing starch that can be used as excipients 6
• Global collaborative efforts of regulatory agencies, pharmaceutical companies, and excipient manufacturers are needed to implement a gluten-free medication policy 6
• Development of databases from manufacturer data to increase healthcare professionals' knowledge of gluten-containing/gluten-free medications 7

For patients with celiac disease, vigilance regarding medication ingredients is essential, and consultation with pharmacists about the gluten content of prescribed medications is strongly recommended 1.