Hepatotoxicity related to Herbals and Dietary Supplements (HDS): a cause for concern

Abstract

August 2015 e123 Assessment and Drug Research, Coimbra, Portugal; and University of Coimbra, School of Pharmacy, Coimbra, Portugal Background: Drugs either used in the treatment of ocular or systemic pathologic conditions have the potential to cause adverse events in the eye and to affect ocular functions. Ocular adverse events are the fewest adverse events studied and assessed in post-marketing surveillance. The investigation of the regulatory actions resulting from the identification of serious ocular disorders associated with the use of drugs, irrespective of being locally or systemically administered, during the last decade, is of utmost importance given its implication for the clinical practice. Material and Methods: The websites of four health regulatory authorities were reviewed to identify safety alerts issued on ocular adverse events. Safety alerts were included if they have been issued between January 2005 and December 2014. Only safety alerts on drugs with market authorization were considered for inclusion. Results: Thirty-eight safety alerts were included in the study. “Urologicals” (n = 11; 29%), followed by “Drugs used in diabetes”, “Antibacterials for systemic use”, “Antioneplastic agents”, and “Ophthalmologicals” were the most frequent suspected drugs evaluated in the safety alerts (n = 4; 10%, each). The most frequently evaluated adverse events were “Visual disorders NEC” (n = 12; 32%), including visual impairment, diplopia, and blurred vision. The majority (n = 25; 66%) of the safety alerts were supported by postmarketing spontaneous reports. The most commonly updated drug label section was the “Warnings and Precautions” section (n = 33; 87%), followed by the “Adverse reactions” section (n = 26; 68%). Conclusion: Ocular adverse events newly identified during this decade come mostly from systemic drugs, some of them marketed for several years. Physicians should be aware of drug-induced adverse effects in the eye in order to avoid as soon as possible their progression, which can lead to visual impairment.