Welcome to FDA Drug Safety Podcasts for health care professionals. This is Karla Waters, Consumer Safety Officer from the Division of Drug Information.
On May 19, 2016, FDA announced it is warning health care professionals to avoid prescribing the antifungal medicine ketoconazole oral tablets to treat skin and nail fungal infections. Use of this medication carries the risk of serious liver damage, adrenal gland problems, and harmful interactions with other medicines that outweigh its benefit in treating these conditions, which are not approved uses of the drug.
We approved label changes for oral ketoconazole tablets in 2013 to reflect these serious risks and to remove the indication for treatment of skin and nail fungal infections. However, an FDA safety review found that oral ketoconazole continues to be prescribed for these types of conditions. 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. Since the 2013 labeling change, one patient death was reported to the FDA due to liver failure associated with oral ketoconazole prescribed to treat a fungal infection of the nails.
Health care professionals should use ketoconazole tablets only to treat serious fungal infections when no other antifungal therapies are available. Skin and nail fungal infections in otherwise healthy persons are not life-threatening, so the risks associated with oral ketoconazole outweigh the benefits. Other treatment options available over-the-counter and by prescription, are also associated with risks that should be weighed against their benefits.
Ketoconazole tablets are indicated for serious fungal infections when other effective therapy is not available or tolerated. Topical forms of ketoconazole applied to the skin or nails have not been associated with liver damage, adrenal problems, or drug interactions.
In a July 2013 Drug Safety Communication, we warned ketoconazole tablets should not be used as first-line treatment for any fungal infection because of severe liver injury, adrenal gland problems and possible harmful interactions with other medicines. We also removed the indication for skin and nail fungal infections from the drug label and limited the indication to treating only serious fungal infections.
Side effects involving ketoconazole should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.
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- FDA Drug Safety Communication: FDA warns that prescribing of Nizoral (ketoconazole) oral tablets for unapproved uses including skin and nail infections continues; linked to patient death
- FDA Drug Safety Podcast: FDA warns that prescribing of Nizoral (ketoconazole) oral tablets for unapproved uses including skin and nail infections continues; linked to patient death