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Winter-Spring 2017, Volume 11 Issue 1

Winter-Spring 2017
At Pharmedix®™ we frequently get asked about gluten content in pharmaceuticals. The significance of the presence of gluten in drug products probably depends on whether the patient in question has true celiac disease or, as an increasing number of people state, they are “allergic” to gluten”. However, as pharmaceuticals are concerned, very few drug companies state that their products are “gluten free” even if they are. For the ones that do, we will print on your tray label with the ingredients “gluten free”. As far as other drug products are concerned they may or may not be gluten free.
Gluten can be present in drug products as a component of inactive ingredients called excipients which are added during the manufacturing process. It is these inactive ingredients that have the greatest potential to be a source of gluten. Any product not labeled gluten-free and has starch excipients from a non specified source, signal the potential for gluten in the product. For example unspecified starch 18-20 or pre-gelatinized starch may be derived from wheat while other starch derivatives such as sodium starch glycolate, dextrin and maltodextrin usually but not always come from potato or corn starch. Sugar alcohols known as polyols (e.g. mannitol and, sorbitol) are highly processed sugars and do not contain wheat gluten. The botanical source of each starch ingredient, which is frequently NOT listed in the package insert, must be determined before you can establish if a product is GLUTEN FREE. However, even if you contact a pharmaceutical company and they tell you that a particular product is gluten free they usually WILL NOT guarantee it since botanical sources of different excipients can change without the package insert being altered or because of possible cross-contamination on the manufacturing line. The only absolute safe bet for a patient with celiac disease is to find a product specifically labeled as GLUTEN FREE.
For example, Roxane makes gluten free prednisone. As far as patients who say they are “allergic to gluten, it becomes an issue of risk benefit. For your more information there are several websites (search “gluten ingredients in medications” ) which attempt to provide information about gluten content of pharmaceuticals.

Winter-Spring 2017
After several years of this author complaining about the cost of Epi-Pens, it took a presidential election for someone to finally pay attention to the problem. Although not widely publicized, it came to light that the parents of the CEO of Mylan, Heather Bresch, may have helped push the price of Epi-Pen up. It was her mother, Gayle Manchin, as head of the National Association of State School Boards and her father, Senator Joe Manchin (D) a member of the Senate Commerce Committee, that pushed to have epinephrine auto injectors placed in every school in the nation. And to boot, Mylan is one of the pharmaceutical companies to benefit from tax inversion (another issue this author has complained about). Mylan whose main office is near Pittsburg, is now legally headquartered in the Netherlands after a 2015 tax inversion with Abbott Labs. Despite a hefty fine paid to the federal government, Mylan walked away with huge profits on a product which doesn’t cost much to make.

Winter-Spring 2017