TRHC Position Paper on the Public Health Risk of Strongly Anticholinergic Over-the-Counter Products

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Executive Summary
In the United States, over-the-counter (OTC) products are consumed by millions of people to self-medicate and, thereby, take an active role in their health care. However, despite public belief, not all OTCs are safe for all people. Over-the-counter products containing drugs with strong anticholinergic properties, such as chlorpheniramine and diphenhydramine, are ubiquitous and can cause myriad side effects, particularly for older Americans. Some anticholinergic side effects can be temporarily severe and disabling. But, more disturbing is the fact that anticholinergic drugs can cause insidious, permanent cognitive and physical dysfunctions, such as dementia, which may not manifest for years after [repeated] consumption. Consequently, OTC products with strong anticholinergic properties pose a threat to the health and well-being of our nation’s older adult population. The silent epidemic of anticholinergic-induced side effects and dysfunctions amongst older Americans requires immediate action.

As a national organization that advocates for patient safety and focuses on mitigating medication risks, Tabula Rasa HealthCare calls on Norman E. Sharpless, M.D. (Commissioner) to request that the U.S. Food and Drug Administration (FDA) mandate that manufacturers of OTC products with strong anticholinergic properties place warnings about anticholinergic-induced side effects and dysfunctions on their product labels. Such a directive would inform the public, notably older adults, about the risks associated with consuming these OTCs. In turn, these consumers can make better-informed decisions about their health care.

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