Journal of Pharmacovigilance

Abstract

Macular Supplements Containing Zinc and Vitamin A Should Be Replaced with Meso-Zeaxanthin, Lutein and Zeaxanthin: An Ophthalmic Need for Pharmacovigilance

Michael J Tolentino

Objective: The objective of this paper is to report the importance of ophthalmic pharmacovigilance in AREDS macular formulations due to the potential toxicity of these macular vitamins with minimal benefit for patients with advanced exudative macular degeneration.

Background: Age Related Eye Disease Studies macular formulations are currently treated as nutritional supplements and as such, do not undergo the required evaluation process for toxicity as pharmacologic agents. However, they more closely resemble a pharmacologic agent rather than a true nutritional supplement.

Results: Macular formations have minimal benefit for patients with advanced exudative age-related macular degeneration and contain unsafe doses of substances like beta-carotene and zinc, which have the potential to cause cancer, Alzheimer’s disease, and worsen macular degeneration. This potential for toxicity necessitates pharmacovigilance for macular supplements to prevent exposure to harmful substances for negligible gain.

Conclusion: These supplements should be replaced with other compounds that have both macular protective properties and an excellent safety profile such as Meso-Zeaxanthin, lutein and zeaxanthin.