A
new document from the U.S. Food and Drug Administration (FDA): This guidance is intended to convey to drug
manufacturers FDA’s recommendations on how certain drug products should be
labeled regarding gluten, a matter of interest to individuals with celiac
disease. Some individuals with celiac disease have faced difficulty when trying
to determine whether specific drug products contain gluten. Confronted by
uncertainty, some patients may forego important medication rather than risk an
adverse reaction to gluten. Thus, even if gluten is not present at levels that
would harm a typical individual with celiac disease, that individual may be
harmed through uncertainty and lack of information.
Celiac
disease (also known as celiac sprue) is an immune-based reaction to dietary
gluten that
primarily
affects the small intestine in susceptible individuals; unmanaged celiac
disease can lead to serious health complications. Approximately 1 percent of
the U.S. population has celiac disease. It is characterized by ongoing
inflammation of part of the lining of the small intestine that generally heals
if foods containing gluten are excluded from the diet and returns if they are
reintroduced. At this time, the treatment for celiac disease is adherence to a gluten-free
diet.
See FDA
Posted by Dr. Tim Sandle
No comments:
Post a Comment
Pharmaceutical Microbiology Resources