Gluten in Medication: Qualifying the extent of exposure to people with celiac disease and identifying a hidden and preventable cause of an adverse drug event

Beyond Celiac received a grant from the Food and Drug Administration (FDA) as part of its Safe Use Initiative to study the impact of gluten in medications on people with celiac disease. Beyond Celiac assembled a Research Team led by Loretta Jay, MA, consultant to Beyond Celiac, Parasol LLC, and Robert A. Mangione, RPh, EdD Provost and Professor, St. John’s University to understand the issues surrounding gluten in medications and to determine if gluten is, in fact, present in prescription and over-the-counter medications.

The Beyond Celiac team collected information from 5,623 people with celiac disease and non-celiac gluten sensitivity (‘gluten sensitivity’) through an online survey. 1,399 of these respondents reported that they suspected an adverse reaction caused by gluten in their medication.

The research team analyzed results from testing 39 drugs reported by these respondents, including the seven most frequently reported over-the-counter and eight most frequently reported prescription drugs and 24 additional drugs. It is important to note that this a small sample of the total number of medications available to consumers in the US.

Key findings are:

• No safe threshold has been established for trace amounts of gluten in medications.
• The current testing methods used to check foods for gluten content is not what is needed to check medications for gluten. The effectiveness of tests in medication have not been proven by science.
• Patients and healthcare providers find it extremely hard to figure out whether a medication is gluten-free. This causes many people anxiety, lack of confidence, medication substitutions and non-compliance with taking their medications.
• Patients are reporting symptoms of perceived gluten exposure that are inconsistent with known side effects for those drugs.
• A substantial number of the 39 drugs tested based on criteria created by the Research Team tested below the level of quantification, while some of the drugs tested were over this level of quantification. Additional drugs could test above that limit when dosage is considered, a clear indicator for the need for additional research.

This foundational review confirms that more research is needed so the pharmaceutical industry and federal regulators can understand the harm caused by gluten in medications for people with celiac disease. These groups can reduce the damage caused by accidental gluten exposure through medicine using such research as a guide.

This research report identifies several issues for further study that are necessary to understand how to properly source, test and label gluten found in inactive ingredients commonly found in prescriptions and over-the-counter medications.

Learn more about the issues with gluten in medications here.

Loretta Jay, MA, is President of Parasol, LLC, and has more than twenty-five years of experience in comprehensive program design, implementation and evaluation, including wide-ranging experience in the design and conduct of accredited educational programs and research studies. With a Master’s degree in Community Psychology, Ms. Jay’s writing about celiac disease and food allergy has been published domestically and internationally; public health officials, legislators and policy-makers at the federal, state and local levels call upon her for guidance to yield improved services and streamline policy and protocols about medically required food restrictions to better meet the population’s needs.

Robert Mangione, RPh, Provost and Professor of Pharmacy, has been a member of the St. John’s University faculty for over 35 years. He earned his B.S. in Pharmacy and M.S. in Pharmaceutical Sciences (Clinical Pharmacy) from St. John’s University College of Pharmacy and Health Sciences as well as a P.D. and an Ed.D. in Educational Administration and Supervision from St. John’s University, School of Education. His research interests include Pharmaceutical Care for Patients with Celiac Disease, Pediatric Pharmacotherapy, and Poverty Issues in Healthcare and Education. He has authored or co-authored over 100 publications in the professional literature.

Key Research Personnel:

• Somnath Pal, Ph.D., MBA, MS
• S. William Zito, Ph.D.
• Carmela Avena–‐Woods, PharmD, CGP
• Gregory G. Sarris, MS
• Dharam V. Ajmera, MS
• Steven Pak

Read the executive summary on the gluten in medications study.

Click here for the full technical research report, “Gluten in Medication: Qualifying the extent of exposure to people with celiac disease and identifying a hidden and preventable cause of an adverse drug event.”

Note:

At the time of this research, Beyond Celiac was known as the National Foundation for Celiac Awareness. Learn more about the name change here.