Gluten in Medications: FDA Wants to Hear from You!

by Cheryl Harris, MPH, RD, LD on February 14th, 2012


Cheryl Harris Gluten Free Works

The FDA opened a 90 day comment period on gluten in medications. One of the things we learned from 1 in 133 is that when we make it clear how many people care about gluten labeling, movement happens.  Let’s give the message that we feel this is important!

Gluten in Medications:

We know that most packaged foods on the grocery shelf in the U.S. will have straight-forward 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 and a list from a support group. You can also buy a list, such as Clan Thompson. However, ingredients in medications can always change, so these lists can best be seen as a starting point. Here’s a flyer from the American Society of Health-System Pharmacists on gluten in medications. Here’s a list for contact information for various supplement companies.

    Comments must be submitted to FDA by March 20, 2012.
    For more information: http://www.gpo.gov/fdsys/pkg/FR-2011-12-21/html/2011-32551.htm

    To submit your comment, go here: http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0842-0001

    Also, NFCA is dong a survey on gluten in medications through Feb 28, 2012 http://www.celiaccentral.org/Survey/

     

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    Author Information: Cheryl Harris, MPH, RD, LD, Alexandria, VA, USA.
    Cheryl Harris, MPH, RD, LD, Registered Dietitian and Nutritionist.  Her passion is teaching people to live and love a gluten-free diet in the Northern Virginia area. For more, seewww.harriswholehealth.com or follow on Twitter @cherylharrisrd


    One Response to “Gluten in Medications: FDA Wants to Hear from You!”

    1. My husband, two daughters, sister, two nephews and I suffer from Celiac Disease and urge the FDA to disclose the gluten in medications as well as if those gluten-free medications are manufactured in a gluten-free facility. Without this information, our health is put at risk.

      Thank you for your time and attention to this matter.

      Sincerely,
      Priscilla Matuson

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