US Pharm. 2016;41(6):10.
Silver Spring, MD—The FDA is reminding healthcare professionals to avoid prescribing ketoconazole oral tablets to treat skin and nail fungal infections. Despite a 2013 warning that this antifungal can cause serious liver damage and adrenal gland problems, a recent FDA safety review found that oral ketoconazole continues to be prescribed for these types of conditions. Since the 2013 labeling change, one patient death has been reported to the FDA due to liver failure associated with off-label use. Healthcare professionals should use ketoconazole tablets to treat serious fungal infections only when no other antifungal therapies are available.
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