Gluten in Pharmaceutical Products

and

Disclosures

Am J Health Syst Pharm. 2001;58(5) 

In This Article

Discussion

The information obtained from this survey, although somewhat dated, highlights the challenges in obtaining gluten-free drug and nutritional products. Few companies reported definitively that their products were gluten free. Raw materials obtained from outside sources were the primary reason for this ambiguity.

Gluten, when present in drug and nutritional products, is a component of inactive ingredients added during manufacturing. Inactive ingredients derived from whole grains, grain flour, or grain starch are the most common sources of gluten. Excipients, such as unspecified starch 18-20 or pregelatinized starch,[18,20] dusting powder, flour, and gluten,[3,21] may be derived from wheat. These inactive ingredients have the highest potential to be sources of gluten in drug and nutritional products. Dextri-Maltose and caramel coloring may be sources of gluten when barley malt is used in manufacturing.[20,22] Other starch derivatives, such as sodium starch glycolate, [20,23] dextrin,[24] and maltodextrin,[20] are processed almost exclusively from potato starch or cornstarch but may rarely be derived from other starches. The botanical source of each of these ingredients must be determined before the product can be considered safe for the celiac disease patient.

Procuring gluten-free products is facilitated when a pharmaceutical company has an established policy of producing only gluten-free products. In such a case, much of the uncertainty about the appropriateness of a product for the celiac disease patient is removed. Only five of the companies surveyed had such a policy, however. Further complicating the picture is that information is only as current as the date on which it was communicated. Consequently, the patient, the pharmacist, or the physician must contact a manufacturer periodically to be sure that a given product's status has not changed. It is best to refer to the lot number of the product whenever possible.

The claim "new formulation," "new product appearance," or "new manufacturer" on a product label is an important indicator of a potential change in the product's gluten status. Either active ingredients or excipients may have changed. Such claims should alert the health care provider or the patient to contact the manufacturer to determine if the change affected the product's gluten status.

For patients with celiac disease, any medication that enters the gastrointestinal tract, whether it is orally or rectally administered, must be gluten free. The risk of inadvertent gluten ingestion comes not only from limited knowledge about potential gluten-containing excipients but also from failure to disclose excipient sources in package labeling. In our survey, a significant number of respondents were not aware of excipients other than wheat starch that may contain gluten. Currently, a few prescription medications are actually labeled "gluten free" (e.g., prednisone and dexamethasone tablets manufactured by Roxane Laboratories). If this information were included on all gluten- free medications, it would greatly help those with celiac disease avoid gluten intake. A reliable means of identifying and obtaining gluten-free medications and nutritional products is essential to the health of these persons.

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