Unapproved Use of Antifungal Linked to Patient Death

In 2013 indications for skin and nail fungal infections were removed from the labeling
In 2013 indications for skin and nail fungal infections were removed from the labeling

The Food and Drug Administration is warning healthcare practitioners not to use ketoconazole oral tablets for the treatment of skin and nail fungal infections.

The labeling for ketoconazole oral tablets had been updated back in 2013 to remove the indications for skin and nail fungal infections, however an FDA safety review indicates that the drug continues to be prescribed for these conditions. Roughly 217,000 patients have received dispensed prescriptions for oral ketoconazole in the U.S. during the 12-month period ending in June 2015. In this same time period, an office-based physician surveys database showed skin and nail fungal infections were the primary diagnosis associated with oral ketoconazole use. Since the change to the labeling was made, the FDA has been notified of one report of death due to liver failure associated with oral ketoconazole prescribed to treat a fungal infection of the nails. 

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The FDA reiterates that healthcare professionals should use oral ketoconazole tablets to treat only serious fungal infections when no other antifungal treatments are available. The risks associated with using oral ketoconazole for skin/nail fungal infections outweigh the benefits and clinicians should look to other therapies. 

Ketoconazole tablets are currently indicated for the treatment of susceptible systemic fungal infections (blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis) in those who have failed or are intolerant to other therapies.

The topical formulations (creamshampoo) of ketoconazole have not been associated with liver damage, adrenal problems, or drug interactions.

For more information visit FDA.gov

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