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Retrospective analysis of adverse events with topical onychomycosis medications reported to the United States Food and Drug Administration
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Retrospective analysis of adverse events with topical onychomycosis medications reported to the United States Food and Drug Administration
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Journal Article
Retrospective analysis of adverse events with topical onychomycosis medications reported to the United States Food and Drug Administration
2020
Overview
Topical onychomycosis therapy is commonly prescribed due to its tolerability and low incidence of side effects. There are limited data on adverse events associated with the newer topical onychomycosis drugs. The objectives of this study is to classify the most common adverse reactions associated with ciclopirox 8% solution, efinaconazole 10% solution, and tavaborole 5% solution. The United States Food and Drug Administration Adverse Event Reporting (FAERS) database was analyzed for the most common adverse reactions associated with ciclopirox 8% solution, efinaconazole 10% solution, and tavaborole 5% solution. Google Trends was used to examine public interest in these drugs and these data were compared with yearly adverse events in the FAERS database. The most common adverse reactions associated with ciclopirox 8% solution, efinaconazole 10% solution, and tavaborole 5% solution were drug ineffectiveness. Application site erythema and nail discoloration were reported with all three medications. Increased Google searches for efinaconazole and tavaborole were associated with increased in reporting of adverse events to the FDA. Topical antifungals are safe alternatives for patients who have contraindications to oral medications. For improved efficacy, physicians should confirm the diagnosis of onychomycosis and choose appropriate candidates before starting topical therapy. Patients should be given clear instructions on drug usage and counseled about the more common side effects, including application site reactions and nail discoloration.
Publisher
Springer Berlin Heidelberg,Springer Nature B.V
Subject
/ Adverse Drug Reaction Reporting Systems - statistics & numerical data
/ Antifungal Agents - adverse effects
/ Boron Compounds - administration & dosage
/ Boron Compounds - adverse effects
/ Bridged Bicyclo Compounds, Heterocyclic - administration & dosage
/ Bridged Bicyclo Compounds, Heterocyclic - adverse effects
/ Ciclopirox - administration & dosage
/ Ciclopirox - adverse effects
/ Erythema
/ Erythema - chemically induced
/ Humans
/ Medicine
/ Onychomycosis - drug therapy
/ Pain
/ Pruritus
/ Trends
/ Triazoles - administration & dosage
/ United States Food and Drug Administration - statistics & numerical data
