The National Foundation for Celiac Awareness (NFCA) has received a grant from the Food and Drug
Administration (FDA) to fund the first scientific research in the area of gluten in medication. The
project entitled, “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,” will characterize
the problem of unlabeled gluten in medication and raise awareness of the potential harm that can
occur to patients who ingest medications that they do not recognize as containing gluten, a protein
found in wheat, barley, rye and their various derivatives.
Although gluten may be included in excipients used in medications, there currently are no
regulations requiring drug manufacturers to label the source of excipients used in their
prescription or over-the-counter (OTC) medications. To date, there has been no scientific research
conducted to determine if the amount of gluten that is in medication results in harm to people with
celiac disease or gluten sensitivity, although there are reports of significant patient reactions
to gluten in medication.
This preliminary research aims to validate or nullify the anecdotal adverse experiences associated
with gluten in medications that are reported by the celiac and gluten sensitive patient population.
Findings from this project will provide a foundation for future investigation within the FDA and
scientific communities, through which additional research, labeling, and safe use guideline
initiatives can advance. Information about this grant can be found at: Click Here