Investors Hangout Stock Message Boards Logo
  • Mailbox
  • Favorites
  • Boards
    • The Hangout
    • NASDAQ
    • NYSE
    • OTC Markets
    • All Boards
  • Whats Hot!
    • Recent Activity
    • Most Viewed Boards
    • Most Viewed Posts
    • Most Posted
    • Most Followed
    • Top Boards
    • Newest Boards
    • Newest Members
  • Blog
    • Recent Blog Posts
    • Recently Updated
    • News
    • Stocks
    • Crypto
    • Investing
    • Business
    • Markets
    • Economy
    • Real Estate
    • Personal Finance
  • Market Movers
  • Interactive Charts
  • Login - Join Now FREE!
  1. Home ›
  2. Stock Message Boards ›
  3. User Boards ›
  4. NASDAQ OMX GlobeNewswire Message Board

FDA offers guidance on gluten-labeling for medicat

Message Board Public Reply | Private Reply | Keep | Replies (0)                   Post New Msg
Edit Msg () | Previous | Next


Post# of 301275
(Total Views: 52)
Posted On: 12/13/2017 11:00:25 PM
Avatar
Posted By: News Desk 2018
FDA offers guidance on gluten-labeling for medications

Philadelphia, PA, Dec. 13, 2017 (GLOBE NEWSWIRE) --

Gluten in medications is a hot topic within the celiac disease community. The US Food and Drug Administration today issued draft guidance for drug manufacturers to clarify when a gluten-containing ingredient has been used to make prescription and over-the-counter drugs. Gluten is a protein found in wheat, barley and rye. This comes three years after the FDA set voluntary guidelines for labeling foods gluten free.

The guidance encourages drug makers to voluntarily include a statement that their drug "contains no ingredient made from a gluten-containing grain (wheat, barley or rye)" when such a statement is "truthful and substantiated" in the description section of the drug's prescribing information.

“We at Beyond Celiac – formerly the National Foundation for Celiac Awareness – have been working on addressing the issue of gluten in medications for a decade.” said Alice Bast, Beyond Celiac CEO. “Though the labeling is voluntary, it is definitely a step in the right direction.”

Beyond Celiac has heard repeatedly from its constituents that undisclosed gluten in medications was making them sick. With the goal of turning anecdotes into documented, quantifiable research, the organization received a $50,000 grant in 2011 from the FDA to study the prevalence of hidden gluten in medications, the first study of its kind. The Food Allergen Labeling Consumer Protection Act (FALCPA) of 2004, which requires packaged food labels to identify all ingredients containing wheat and other common allergens, was a major landmark for people with celiac disease and food allergies. Medication labels were not included in FALCPA.

In 2011, 5,623 people with celiac disease and gluten sensitivity responded to an online survey. 1,399 of these respondents – 25% – reported that they suspected an adverse reaction caused by gluten in their medication.

Patients and healthcare providers find it difficult to ascertain whether a medication is gluten‐free, causing anxiety, lack of confidence, medication substitutions and noncompliance. Patients reported a wide range of symptoms associated with their suspected gluten exposure, including: constipation, nausea, diarrhea, abdominal pain, bloating, headache, fatigue, irritability, muscle tremors/cramps, failure to thrive and skin rash. Some of the reactions reported by survey respondents are also known side effects of these mediations, others are not.

“We will continue to fight for accurate labeling and advocate for funding for further research and if appropriate, the elimination of gluten in medications all together,” Bast stated. “Our community’s health and well-being is at stake.”

For a person with celiac disease, undigested gluten fragments trigger a reaction by the immune system in the small intestine, which can lead to systemic inflammation. The relationship to the gut and the microbiome, which is evolving as central to overall health in general, is well-documented. Systemic damage caused by gluten can be catastrophic, affecting not only the GI system, but also the brain and nervous system. Attending to the gut-brain connection is an important part of overall healthcare for the celiac disease community.

Beyond Celiac recently held its first research symposium to accelerate the search for better treatments for celiac disease. Additionally, the new Go Beyond Celiac online patient platform and registry is designed to bring patients and scientists together to speed progress on celiac disease research.

About Beyond Celiac Beyond Celiac, a 501 (c)(3) non-profit organization formerly known as the National Foundation for Celiac Awareness, unites with patients and partners to drive diagnosis, advance research and accelerate the discovery of new treatments and a cure. For more information, please visit www.beyondceliac.org.

Attachments:

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/Attachm...ae1dd2906d

Claire Baker Beyond Celiac` 215-325-1306 ext. 111 cbaker@beyondceliac.org



(0)
(0)








Investors Hangout

Home

Mailbox

Message Boards

Favorites

Whats Hot

Blog

Settings

Privacy Policy

Terms and Conditions

Disclaimer

Contact Us

Whats Hot

Recent Activity

Most Viewed Boards

Most Viewed Posts

Most Posted Boards

Most Followed

Top Boards

Newest Boards

Newest Members

Investors Hangout Message Boards

Welcome To Investors Hangout

Stock Message Boards

American Stock Exchange (AMEX)

NASDAQ Stock Exchange (NASDAQ)

New York Stock Exchange (NYSE)

Penny Stocks - (OTC)

User Boards

The Hangout

Private

Global Markets

Australian Securities Exchange (ASX)

Euronext Amsterdam (AMS)

Euronext Brussels (BRU)

Euronext Lisbon (LIS)

Euronext Paris (PAR)

Foreign Exchange (FOREX)

Hong Kong Stock Exchange (HKEX)

London Stock Exchange (LSE)

Milan Stock Exchange (MLSE)

New Zealand Exchange (NZX)

Singapore Stock Exchange (SGX)

Toronto Stock Exchange (TSX)

Contact Investors Hangout

Email Us

Follow Investors Hangout

Twitter

YouTube

Facebook

Market Data powered by QuoteMedia. Copyright © 2025. Data delayed 15 minutes unless otherwise indicated (view delay times for all exchanges).
Analyst Ratings & Earnings by Zacks. RT=Real-Time, EOD=End of Day, PD=Previous Day. Terms of Use.

© 2025 Copyright Investors Hangout, LLC All Rights Reserved.

Privacy Policy |Do Not Sell My Information | Terms & Conditions | Disclaimer | Help | Contact Us