Abstract
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.
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Abbreviations
- US:
-
United States
- FDA:
-
Food and Drugs Administration
- FAERS:
-
Food and Drugs Administration Adverse Event Reporting Database
References
de Berker D (2009) Clinical practice. Fungal nail disease. N Engl J Med 360(20):2108–2116
Lipner SR, Scher RK (2019) Onychomycosis: treatment and prevention of recurrence. J Am Acad Dermatol 80(4):853–867
Lipner SR, Scher RK (2019) Onychomycosis: clinical overview and diagnosis. J Am Acad Dermatol 80(4):835–851
Faergemann J et al (1995) Double-blind, parallel-group comparison of terbinafine and griseofulvin in the treatment of toenail onychomycosis. J Am Acad Dermatol 32(5 Pt 1):750–753
Haneke E et al (1995) Short-duration treatment of fingernail dermatophytosis: a randomized, double-blind study with terbinafine and griseofulvin. LAGOS III Study Group. J Am Acad Dermatol 32(1):72–77
Hofmann H et al. (1995) Treatment of toenail onychomycosis. A randomized, double-blind study with terbinafine and griseofulvin. LAGOS II Study Group. Arch Dermatol 131(8): 919–922.
Korting HC et al (1993) Treatment of tinea unguium with medium and high doses of ultramicrosize griseofulvin compared with that with itraconazole. Antimicrob Agents Chemother 37(10):2064–2068
Walsoe I, Stangerup M, Svejgaard E (1990) Itraconazole in onychomycosis. Open and double-blind studies. Acta Derm Venereol 70(2):137–140
Food and Drug Administration Penlac Nail Lacquer Tropical Solution. FDA approval information. https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-022_Penlac.cfm. Accessed 02 Oct 2019.
Food and Drug Administration Jublia topical solution (efinaconazole). FDA approval information. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203567_jublia_toc.cfm. Accessed 02 Oct 2019.
Food and Drug Administration Kerydin. FDA approval information. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204427 Accessed 02 Oct 2019.
Federal Drug Administration (2019) Federal Drug Administration adverse event reporting system [database]. https://fis.fda.gov/sense/app/d10be6bb-494e-4cd2-82e4-0135608ddc13/sheet/33a0f68e-845c-48e2-bc81-8141c6aaf772/state/analysis.
Google (2019) Google Trend [database]. https://trends.google.com/trends/?geo=US.
Penlac nail lacquer (ciclopirox) topical solution, 8% [package insert]. Bridgewater, NJ: Dermik Laboratories. https://products.sanofi.us/penlac/penlac.html. Accessed 25 Sep 2019.
Jubilia (efinaconazole) topical solution, 10% [package insert]. Bridgewater, NJ: Valeant Pharmaceuticals. https://www.valeant.com/Portals/25/Pdf/PI/Jublia-PI.pdf. Accessed 25 Sep 2018.
Kerydin (tavaborole) topical solution, 5% [package insert]. Melville, NY: Fougera Pharmaceuticals. https://dailymed-nlm-nih-gov.proxy.library.stonybrook.edu/dailymed/drugInfo.cfm?setid=1ae61072-bca0-43f0-a741-07bda2d50c87. Accessed 27 Sep 2019.
Lamisil (terbinafine hydrochloride) tablets [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation. https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/Lamisil_tablets.pdf. Accessed 25 Sep 2019.
Food and Drug Administration Lamisil. FDA approval information. https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020749_lamisil_toc.cfm. Accessed 02 Oct 2019.
Lipner SR, Scher RK (2016) Confirmatory testing for onychomycosis. JAMA Dermatol 152(7):847
Lipner SR, Scher RK (2016) Onychomycosis—a small step for quality of care. Curr Med Res Opin 32(5):865–867
ClinicalTrials.gov. (2019) Efficacy and safety of AN2690 topical solution to treat onychomycosis of the toenail. https://clinicaltrials.gov/tavaborole. Accessed 1 Nov 2019
ClinicalTrials.gov. (2019) An evaluation of the safety and pharmacokinetics of tavaborole topical solution for the treatment of fungal disease of the toenail in children and adolescents. https://clinicaltrials.gov/tavaborole. Accessed 01 Nov 2019
ClinicalTrials.gov. (2019) Efficacy and safety evaluation of AN2690 topical solution to treat onychomycosis of the toenail. https://clinicaltrials.gov/tavaborole. Accessed 01 Nov 2019
ClinicalTrials.gov. (2019) Safety and efficacy study of subjects with onychomycosis of the great toenail. https://clinicaltrials.gov/tavaborole. Accessed 01 Nov 2019
Lee K (2002). Drug advertising skyrockets. https://www.cbsnews.com/news/drug-advertising-skyrockets/.
Sinclair N (2016). Tv Ad revenue rising pharmaceuticals drugs. https://finance.yahoo.com/news/tv-ad-revenue-rising-pharmaceuticals-drugs-175632922.html.
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Yu Wang and Dr. Lipner have no conflicts of interest relevant to the content of the submission. This work has not been previously published.
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Wang, Y., Lipner, S.R. Retrospective analysis of adverse events with topical onychomycosis medications reported to the United States Food and Drug Administration. Arch Dermatol Res 312, 581–586 (2020). https://doi.org/10.1007/s00403-020-02044-7
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DOI: https://doi.org/10.1007/s00403-020-02044-7