FDA Sued for Failing to Regulate Gluten in Medications




Wall Street Journal

Gluten in Medications

What would you do if you are allergic to wheat gluten and, therefore, could not take certain medicines?

This is a dilemma for Michael Weber, who suffers from celiac disease, which is an autoimmune disorder that can occur in genetically predisposed people who ingest the protein. This can damage the small intestine and lead to neurological diseases, among other illnesses. However, the protein is sometimes used to coat prescription drug and over-the-counter medicine capsules, among other things.

After taking a generic drug seven years ago and developing side effects consistent with ingesting gluten, Weber petitioned the FDA to either eliminate wheat gluten in medicines or require new labeling on drugs containing the protein. The agency response has been slow. In 2011, the FDA sought public comments about the issue, but otherwise has not taken action.

So Weber has now filed a lawsuit to demand the FDA do something.

After taking the drug, “I called my pharmacy and they were not able to determine that drug was gluten-free,” says Weber, a medical office assistant in Eastchester, N.Y. “So then I had to find which manufacturer produced the generic. I went to their website and then had to speak to somebody at the company. They said that was not a gluten-free batch… So I had to discontinue taking the drug. I would like to be able to take drugs and not have any fears or go through all these hoops.”

In his lawsuit, he argues the failure to address the issue is hurting millions of Americans. About 1% of the U.S. population has celiac disease, according to the National Foundation for Celiac Awareness. “The absence of rules to address wheat gluten in prescription medications has serious and ongoing public health implications,” says Katie Einspanier, an attorney at Public Citizen, which represents him.

An FDA spokeswoman wrote us that the agency does not comment on pending litigation. We also asked what, if any, steps the agency may take to alert the public to medicines that contain wheat gluten and will update you accordingly. In 2011, a paper issued by the FDA Office of Food Safety detailed the adverse effects people with Celiac disease can suffer from exposure to gluten.

It’s not clear exactly how many medicines contain wheat gluten. A list maintained by Steve Plogsted, a nutrition support pharmacist at Nationwide Children’s Hospital in Columbus, Ohio, shows the protein is found in more than 150 prescription and OTC medicines. He tells us he obtains information from drug makers and government sources, and does this on a voluntary basis without funding.


Tags: FDA, gluten free medication, Gluten-free diet

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    • Michael
    • March 20, 2015

    Hallelujah! We need more litigation like this. I have my pharmacy call the manufacturers and find a gluten-free generic. That can take days, and before, during and after that process, I have to remind the pharmacists and technicians that my pills have to be taken out of an unopened bottle (usually has to be ordered, wait 2 more days) and counted by hand with clean tray and knife or gloves. They usually run all pills through the contaminated counting machine and pour the extras back into the bottle. You would think the pharmacy chains would be on our side to ban gluten in all medications, but nobody can challenge the almighty pharmacy companies.

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