FDA Comment Period on Gluten in Medications!

Gluten in Medications:

We know that most packaged foods on the grocery shelf in the U.S. will follow FDA labeling, at least for ingredients containing wheat. However, this is not the case for medications, and finding accurate and timely information is much more challenging.

Standard prescription labels include only the active ingredients. So if your doctor writes you a prescription for penicillin, the bottle would say x mg of penicillin. It won’t say what anything about any fillers, binders, coatings, excipients, etc. although these substances are a part of most medications. These can, of course, include wheat and barley.

The PDR (Physician’s Desk Reference) often has a list of ingredients but these are tremendously hard to decipher, and most don’t give a source for ingredients. This information requires calling the manufacturer, and waiting an answer from companies. Ideally, get support from a doctor’s office or pharmacist. Many drug companies will not answer consumer inquiries directly. Generally name-brand drugs do have a consistent list of ingredients, but with generics, different fillers are used at different times, depending on cost at a particular moment in time. So one batch may have cornstarch, the next may have wheat starch, and so on. And, of course, a the name-brand may be gluten-free, but that does not necessarily mean anything about the generic drug.

As a dietitian and someone who has had to make those calls for myself and others, I feel like this is a potentially dangerous and unfair system. People who need medications immediately often do not have the time, energy or mental clarity to make a variety of phone calls and wait for answers. It’s important that steps be taken for longer term changes in policy to ensure the safety of people who need to strictly avoid gluten.

For the meanwhile,

  • Check into all of the medications and supplements you take.
  • When possible have a knowledgeable doctor or pharmacist call and make inquiries, as this may be a faster route to get information.
  • As with any inquiries, do probe further because even health professionals vary in their knowledge and understanding of Celiac Disease and gluten. (I have had pharmacists say to me that they don’t see “gluten” listed as an ingredient, so it must be safe).
  • It may also be necessary for your doctor to specifically order name-brand drugs in certain cases to ensure they are safe for people with Celiac Disease.
  • If you have other food sensitivities/allergies and cannot get answers or safe medications, a compounding pharmacy may be a great option, as they make medications from scratch. In the DC metro area, that includes the Alexandria Medical Arts Pharmacy in VA and Village Green in DC.

There are a few free resources out there that can help, like www.glutenfreedrugs.com.  However, ingredients in medications can always change, so these lists can best be seen as a starting point.

Also, NFCA is dong a survey on gluten in medications through Feb 28, 2012

Harris Whole Health offers individual sessions, family sessions and group classes to help people eat healthier and feel better! Cheryl works with people to feel and look their best with a range of specialties, including Celiac Disease, food allergies, pregnancy, breastfeeding, vegetarian and vegan diets, preventing diseases and “whole foods” eating. Let’s get you on your way to achieving your goals. For an appointment with Cheryl Harris, Registered Dietitian and Nutritionist, please click here, email or call 571-271-8742.

2 Replies to “FDA Comment Period on Gluten in Medications!”

  1. I’ve gotten glutened from a medication before, so it’s a valid concern. I actually have to use a MUCH more expensive brand name vs the generic to avoid this issue. Thanks for all the links and info, Cheryl. I’m glad that NFCA is doing a survey and study on this topic, too.


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