A new report in the Journal of Clinical Endocrinology & Metabolism in July 2020 highlights evidence that has been collected over the last 2 decades about the unexpected and undesirable presence of endocrine-disrupting chemicals (EDCs), which have been defined by the Endocrine Society as “chemicals that mimic, block, or interfere with hormones in the body’s endocrine system.” EDCs have been associated with a diverse array of health issues, and although most clinicians are aware that inactive ingredients exist, few know about the potential hormone-disrupting properties that these additives exhibit in medications they prescribe, dispense, or administer.

According to the FDA, inert ingredients are considered any component other than the active ingredient in a drug product; however, that definition does not address the potential unrelated intrinsic activity that ingredient may possess on its own. The authors highlight categories of highest concern, including phthalates, which are chemicals used in extended-release drug-delivery systems and are also contained in popular medications, including proton-pump inhibitors, mesalamine, bisacodyl, and some probiotic supplements. Phthalate EDCs are associated with metabolic and reproductive dysfunction disorders. The authors also noted that there were additional potential exposures in OTC medications, with three of those agents found to contain dibutyl-phthalate (DBP) and 64 containing diethyl-phthalate (DEP).  

These chemicals were also discovered in medications sold in other countries, including Canada and Denmark, where 154 medications were identified as containing five different phthalates and with five of the 154 medications exceeding the recommend daily limit of DBP. Like the U.S. list, these medications also included mesalamine and bisacodyl, but the team reported budesonide and lithium as additional culprits. Altered levels of thyroid hormones and antithyroid antibodies have been observed in patients taking the DBP-tainted mesalamine. The authors referenced another Danish study that highlighted DBP exposure exceeded recommended levels by up to 600% in over half of the patients and in some cases as many as 90% of individuals taking lithium.

Lead author Robert Michael Sargis, MD, PhD, affiliated with the University of Illinois at Chicago, and colleagues explore the role and responsibility of healthcare providers who have been unknowingly exposing their patients to EDCs. The study authors described mounting evidence about the capacity and degree of influence that EDCs have in altering hormonal activity and how synthetic chemicals have the capacity to alter normal physiologic function. The authors promoted shifting the focus to informing providers of their ethical and clinical responsibility surrounding the EDCs in prescribed medications and requiring transparency from industry to label these additional chemical ingredients in a manner that allows prescribers the opportunity to fulfill their ethical obligations to their patients. 

According to Dr. Sargis, “Through the prescribing of medications and the use of medical supplies, healthcare providers expose patients to chemicals that can disrupt the body’s natural hormones.” Dr. Sargis added, “In order to provide ethically sound medical care, the healthcare community must be made aware of these risks, manufacturers must strive to identify and eliminate endocrine-disrupting chemicals from their products, and patients must be empowered with knowledge and options to make informed decisions that limit their exposure to potentially harmful chemicals. As clinicians, we have an ethical imperative to act on this issue to protect our patients.”

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