[05-19-2016] The U.S. 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. 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 indications for treatment of skin and nail fungal infections.
We approved label changes for oral ketoconazole tablets in 2013 to reflect these serious risks and to remove the indications for treatment of skin and nail fungal infections.
