Staying on a gluten free diet is difficult. Anyone with celiac disease gets used to carefully reading labels of processed food to make sure there is no wheat, barley, rye or gluten in any given product.
Since many people with celiac disease do not have symptoms after consuming gluten, they rely on these labels. Gluten can be causing damage to their intestines that they don’t feel. Finally, after many years, the FDA implemented regulations telling food manufacturers that they must designate clearly whether food does or does not contain gluten.
But what about medications? Are they free from gluten? Are they all labeled? The answer is no. At the current time there are no regulations from the FDA mandating gluten labeling or requiring medications to be gluten free. Gluten can be found in the coating of some capsules and pills or in the starchy filler of some medications, and is usually not listed as an ingredient.
It should be noted that the Food Allergen Labeling and Consumer Protection Act, which was passed in 2004 (and updated in 2013), included wheat and wheat gluten as “major food allergens” and required labeling at that time for food.
In 2008, Michael Weber, who has celiac disease, experienced the symptoms he gets from gluten exposure when taking a generic drug. He asked his pharmacy about possible gluten in the specific medication, but they did not know whether or not in contained any gluten. So he called the company that made the drug, and their spokesperson said that the medication he took was from a batch that was not gluten free.
Weber then filed a petition with the FDA, asking the organization to either require gluten to be removed from all medication, or to mandate accurate labeling of medication. Nothing happened at first. In 2011, the FDA asked for comments from the public about this issue.
Many groups gave comments, asking for regulation of gluten in medication, including the North American Society for the Study of Celiac Disease; the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition; the American Academy of Pediatrics; the Celiac Sprue Association; the American Gastroenterological Association; and the National Foundation for Celiac Awareness.
The time period set for comments has come and gone, and no action has been forthcoming. The petition has not been approved or denied. Weber got a letter dated July 9, 2014 which said that the FDA would respond as soon as they had reached a decision.
In 2015 Weber filed a lawsuit against the FDA in the United States District Court for the District of Columbia.
In the meantime, various individuals and groups are trying to compile a list of safe and unsafe medications. Consumers and researchers have called drug manufacturers asking about the gluten content in specific medications. That is something that anyone with celiac disease can do – call the company that makes the medication. Obviously this is difficult and there is no guarantee that the information received is accurate.
A database of drugs is being compiled at the Robert Wood Johnson University Hospital in New Brunswick N.J.
If you are unsure about the safety of medications you take, either prescription or over the counter, you can look to see if the drug is in the list compiled by the Robert Wood Johnson University, or you can call the drug manufacturer.
The FDA has the authority to make sure that medications are safe. Gluten is not safe for the approximately 1% of the population who have celiac disease. It would seem reasonable to think the FDA has the authority to tell drug manufacturers to include gluten on labels if it is in their products.
It is not known yet what the FDA plans to do about the lawsuit. Until action is taken, people with celiac disease have been left to deal with the safety of needed medications on their own.
Gluten in Drug Products
Petition June 2008
Silverman, Ed. FDA is Sued for Failing to Regulate the Use of Glutens in Medicines. The Wall Street Journal. March 17, 2015.
Robert Wood Johnson University Hospital in New Brunswick N.J. Database of gluten status of medications.
Joseph E. Cruz, Craig Cocchio, Pak Tsun Lai and Evelyn HermesDeSantis. Gluten content of medications. American Journal of HealthSystem Pharmacy. Online January 2, 2015.