Would you ever imagine that your medications, whether prescription or over the counter (OTC), could make you sick?
A recent study published in Science Translational Magazine revealed that 92.8% of oral solid dosage medications contain at least one inactive ingredient that is a potential allergen. Researchers from Massachusetts Institute of Technology and Brigham and Women’s Hospital analyzed the inactive ingredients in more than 42,000 oral medications and found that inactive ingredients may play more of an active role than we previously thought.
Inactive ingredients are components of a medication intended to facilitate absorption, improve stability, taste and appearance, or preserve the active ingredient. On average, an oral medication contains 8.8 inactive ingredients. While inactive ingredients are necessary components of a medication, not all ingredients play a harmless role. In fact, researchers found that 45% of medications contain lactose, 55% contain at least one FODMAP, or hard-to-digest sugar, and 33% contain a chemical food dye.
Why is this important?
First, oral medications are the most common form of prescription and over-the-counter medicines consumed today. Four out of five US adults use over-the-counter (OTC) medications as a first response to minor ailments and make an average of 26 trips to the pharmacy each year to purchase medications.
Second, allergies and autoimmune disorders are on the rise. It is estimated that 75% of the world’s population has lactose intolerance, 15% has irritable bowel syndrome (IBS)and at least 3 million Americans are affected by celiac disease.
The prevalence of potential allergens in medicines people consumer daily is concerning. While some may argue that the amount of potential allergens you are exposed to in a medication is insignificant, researchers found that an average tablet contains 280 mg of inactive ingredients and only 164 mg of the active pharmaceutical ingredient (API). The average American patient over age 65 takes 5 prescription medications daily, accounting for nearly 1.4 g of inactive ingredients, some of which may contain a potential allergen.
Furthermore, the list of inactive ingredients that can act as an allergen or may be potentially contaminated with an allergen is extensive. Ingredients include chemicals like polyethylene glycol, povidone and carboxymethylcellulose; lactose and corn starch; and synthetic dyes like brilliant blue and tartrazine.
Why do medicines still have these ingredients?
Given the wide use of oral medications, the number of adults and children consuming these inactive ingredients is enormous. While some companies have taken strides to reduce the number of inactive ingredients by removing dyes or corn starch, the majority of OTC and prescription drugs today still contain antiquated inactive ingredients lists full of synthetics and chemicals.
I serve as a medical advisor for the only company reformulating OTC medications with cleaner inactive ingredients. Genexa is the first pharmaceutical company to remove artificial dyes, flavors, preservatives and other synthetic inactive ingredients, and replace them with organic, non-GMO and allergen-free ingredients. Most Genexa medicines are certified vegan and certified gluten-free, important for people like myself who are looking for animal-free products. Backed by certifications from the USDA and Non-GMO Project, Genexa is creating commonly used OTC medications to finally provide a solution for the millions of Americans who suffer from an allergy, intolerance or autoimmune disorder.
More pharmaceutical companies should take note of the strides in innovation Genexa has made. Recently, the FDA recommended adding gluten content to product labels, which would help reduce the potential risk for patients with celiac disease or other sensitivities.
More can still be done, and continued research on this previously little-known topic will provide valuable and important information to the pharmaceutical consumer.
Reker, D., Blum, Steven M., Steiger, Christoph, Anger, Kevin E., Sommer, Jamie M., Fanikos, John, and Traverso, Giovanni, “’Inactive’ ingredients in oral medications,” Sci Transl Med 11, eaa6753. DOI: 10.1126/scitranslmed.aau6753.
Consumer Healthcare Products Association. (n.d.). Statistics on OTC Use. Retrieved May 28, 2019, from https://www.chpa.org/MarketStats.aspx
International Foundation for Gastrointestinal Disorders. (n.d.). About Us. Retrieved May 28, 2019, from https://www.aboutibs.org/facts-about-ibs/statistics.html
Celiac Disease Facts and Figures[PDF]. (n.d.). Chicago: The University of Chicago Medicine Celiac Disease Center.