The US FDA is seeking information to help it protect celiac disease patients from pharma ingredients derived from wheat, barley, or rye.
Consumption of gluten by patients with celiac disease stimulates an abnormal immune response and can, over time, lead to severe complications but drug labels have limited information. The US Food and Drug Administration (FDA) is concerned about the impact this may have on patient health.
Evidence gathered by the FDA suggests “wheat is not used to a significant extent in the production of drug ingredients” and use of barley and rye is rare, if it exists at all. However, some drug ingredients may be derived from wheat.
“Some monographs in the National Formulary and the US Pharmacopeia include statements that wheat or wheat starch may be used as source materials. Other monographs include statements that starch may be used as a source material without specifying the plant source”, the FDA wrote .
The FDA is asking for information on any wheat, barley or rye derived ingredients, both active and inactive, used in the US. Comments about the general prevalence of such ingredients, processing steps to remove gluten, and tests for its presence are all sought by the FDA.
Some gluten may also become part of drug products indirectly. While the FDA is primarily interested in deliberately added gluten, it also questions if processing aids, such as filtration media, could be a source.
The FDA wants to know how important these ingredients are to the industry. “What negative consequences, if any, would arise from discontinuing the use of ingredients derived from wheat, barley, or rye in drug products?”, it wrote.
Opportunities to substitute gluten-containing ingredients are discussed. The FDA particularly wants to know if any ingredients must be derived from wheat, barley and rye because of safety, efficacy and other factors.
Scientific evidence of non-harmful gluten levels, if such a thing exists, is on the FDA’s list. The FDA is looking at the impact of different routes of administration, such as topical and injectable, as it seeks to ensure patients have access to accurate information on gluten risks.
“Ingredient information provided on drug labels and information available to pharmacists and physicians may not indicate whether certain drug products contain gluten. Faced with uncertainty, some patients may forego important treatment”, the FDA wrote.
In emergencies the need is more pressing. “Medication is sometimes needed on an urgent basis, not leaving time for an investigation into the drug's gluten content. In some cases, a patient with celiac disease may be unable to confirm the gluten-free status of a drug product”, the FDA wrote.