Celiac.com 03/18/2015 - A man who suffers from celiac disease has sued the FDA for allowing gluten to be used as a coating on prescription drug and over-the-counter medicine capsules.
Remember, people with celiac disease can suffer intestinal damage when they consume gluten. This can damage can lead to neurological, among other disorders.
The man, Michael Weber, was taking a generic drug seven years ago, and developed side effects consistent with ingesting gluten.
Weber says he was unable to determine the drug’s gluten status through his pharmacist, and
Weber went on to petition the FDA to either eliminate wheat gluten in medicines or require new labeling on drugs containing the protein.
In 2011, the FDA sought public comments about the issue. In 2...

Celiac.com 05/12/2015 - The current treatment for celiac disease is the avoidance of gluten-containing foods, beverages, and other products by means of a strict gluten-free diet.
Following such a diet can be challenging, but recent FDA labeling rules go a long way toward helping people with celiac disease know with pretty good certainty whether a food product contains gluten, or is gluten-free.
However, When it comes to prescription drugs, medicines, OTC products, supplements, and vitamins, people with celiac disease currently have little guidance. The FDA rules that mandate the labeling of gluten and other known allergens on food product labels does not apply beyond food. There are currently no rules mandating the labeling of gluten in drugs and medicines. That means that...

Celiac.com 12/20/2017 - The US Food and Drug Administration (FDA) wants drugmakers to provide detailed labeling about gluten in drugs.
The agency's recent draft guidance encourages drugmakers to provide clear labeling about whether their product ingredients contain gluten.
FDA says the guidance is meant to improve consumer knowledge about the presence of wheat gluten in oral drugs.
Unless a drug specifically contains wheat gluten or wheat flour as an ingredient, the agency says it expects most drugs to contain less gluten than a gluten-free cookie.
Under the guidance, the "amount of gluten estimated to be potentially present in a unit dose of an oral drug product (less than 0.5mg) is significantly less than the range at which gluten is estimated to be present in a gluten-free...

Celiac.com 08/22/2018 - There’s been some data to support the idea that local pharmacists might have an important role to play in helping people with celiac disease to remain gluten-free by providing information about possible gluten in drugs, and even liaising with manufacturers for gluten information on the patient’s behalf, as needed.
But how solid is your local pharmacist when it comes to celiac disease awareness? A team of researchers recently set out to evaluate pharmacists' knowledge of celiac disease, and to look for areas where further information may be beneficial.
The research team included Carmela Avena-Woods, PharmD, BS Pharm; Robert A. Mangione, EdD; and Wenchen Kenneth Wu, PhD, MBA. They are all with St. John's University in Queens, New York. To gather data ...