Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics · 2015
Drug-induced ocular adverse reactions: review of the safety alerts issued during the last decade.
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Penedones Ana, Mendes Diogo, Alves Carlos, Marques Francisco Batel
Аннотация
PURPOSE: The purpose of this study was to evaluate ocular-related adverse events associated with the use of drugs by analyzing the content of safety alerts issued by major regulatory authorities during the last decade.
METHODS: The websites of 4 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, antineoplastic agents, and ophthalmologicals were the most frequently 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%).
CONCLUSIONS: 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 events in the eye to avoid, as soon as possible, their progression, which can lead to visual impairment.
METHODS: The websites of 4 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, antineoplastic agents, and ophthalmologicals were the most frequently 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%).
CONCLUSIONS: 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 events in the eye to avoid, as soon as possible, their progression, which can lead to visual impairment.