The Food and Drug Administration is warning health care professionals not to prescribe oral ketoconazole for patients with fungal infections of the skin and nails, because of "the risks of serious liver damage, adrenal gland problems, and harmful interactions with other medicines that outweigh its benefit in treating these conditions."
The advisory, issued on May 19, points out that oral ketoconazole (Nizoral) is no longer approved for treating nail or skin fungal infections. Topical forms of ketoconazole have not been associated with liver damage, adrenal problems, or drug interactions, the advisory adds.
"Health care professionals should use ketoconazole tablets only to treat serious fungal infections when no other antifungal therapies are available," according to the FDA. "Skin and nail fungal infections in otherwise healthy persons are not life-threatening, and so the risks associated with oral ketoconazole outweigh the benefits. Other treatment options are available over-the-counter and by prescription, but are also associated with risks that should be weighed against their benefits."
The advisory updates one issued in July 2013 when the drug's label was changed to reflect these safety concerns, including dropping the nail and skin infections from the approved indications. Since then, the FDA has received one report of a patient who died of liver failure associated with oral ketoconazole used to treat nail fungus. Furthermore, a survey of office-based physicians found that in the 18 months ending in June 2015, "skin and nail fungal infections were the only diagnoses cited for the use of oral ketoconazole."
Serious adverse events associated with oral ketoconazole should be reported to the FDA's MedWatch program online or call 800-332-1088.