Officials with the US Food and Drug Administration (FDA) is warning health care professionals to avoid prescribing the antifungal medicine ketoconazole oral tablets to treat skin and nail fungal infections after at least one patient death was reported to the FDA due to liver failure associated with the antifungal. 

In an updated FDA drug safety communication issued today, officials said they approved label changes for oral ketoconazole tablets in 2013 to reflect risks of serious liver damages, adrenal gland problems and drug interactions, and to remove the indications for treatment of skin and nail fungal infections. 

However, an FDA safety review noted that oral ketoconazole has been prescribed for these types of conditions even after the label change, and was cited as related to one patient death reported to the FDA due to liver failure. The treatment in that case was associated with oral ketoconazole prescribed to treat a fungal infection of the nails. 

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In the 18 months ending in June 2015, skin and nail fungal infections were the only diagnoses cited for the use of oral ketoconazole in an office-based physician surveys database, according to the report. “During the 12-month period ending in June 2015, approximately 217,000 patients received dispensed prescriptions for oral ketoconazole from U.S. outpatient retail pharmacies,” according to the report.

The FDA report noted that “ketoconazole tablets only to treat serious fungal infections when no other antifungal therapies are available.” 


Encuity Research, LLC, Treatment Answers (TM). Jan 2012 through June 2014 & Jan 2014 through June 2015. Extracted August 2015. 

IMS Health: Vector One Total Patient Tracker (TPT). July 2014-June 2015. Extracted August 2015.