Am J Health-Syst Pharm 58(05):396-401, 2001

Celiac.com 04/12/2001 - Patients with celiac disease must eliminate all gluten from their diets, including any that might be present in the pharmaceutical or nutritional products that they consume. Researchers Sister Jeanne Patricia Crowe and Nancy Patin Falini designed a study to identify pharmaceutical companies whose policy is to manufacture only gluten-free products, and to determine the accuracy of product information held by companies whose products might contain gluten. The accuracy of this information is crucial for the effective treatment of patients with celiac disease.

The researchers mailed 172 surveys to pharmaceutical companies listed in the 1998 Physicians Desk Reference and the 1998 generics supplement to Pharmacy Times, and made follow up telephone calls to companies that did not respond. The survey was strictly designed to determine the companies’ policies with regard to the use of gluten in their products, and if they use gluten, to determine their knowledge with regard to its content in their products.

Almost all of the 100 companies that responded to the surveys (52 surveys, 26 letters and 22 oral responses were received) warned that they could not guarantee the possibility that minute amounts of gluten contaminants existed in the raw materials for their inactive ingredients. Many also warned that their products were gluten-free at the time of the survey, but their suppliers of raw materials for their inactive ingredients could change at any time without notice, and this could affect the gluten-free status of their products.

Out of all those who responded, only five had a policy of producing gluten-free products, and could guarantee the gluten-free status of their products. Another group of respondents did not refer to their products as gluten free but stated that they added no ingredients derived from wheat, oats, rye, barley, or spelt. Many companies responded with legal disclaimers stating that although they believed that their products did not contain gluten, they neither certified their gluten-free status nor tested them for gluten. Some said that they could not make this guarantee because of the uncertainty with their suppliers of raw materials. Some said that their responses concerning ingredients were only as current as the date of correspondence.

Currently few medications are labeled “gluten-free,” and labeling medications as such would be a great help to those on gluten-free diets. With most products a patient, pharmacist or doctor must periodically contact the manufacturer to determine the continuing gluten-free status of the product. This process is time consuming and costly for all involved. A reliable means of determining the gluten-free status of medications and nutritional products is badly needed, and is essential to the health of people on gluten-free diets.

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