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FDA Medwatch Alert: Nizoral (ketoconazole) Oral Tablets: Drug Safety Communication - Prescribing for Unapproved Uses including Skin and Nail Infections Continues; Linked to Patient Death
Posted 23 May 2016 by Drugs.com
ISSUE: 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. FDA 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. However, an 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 oral ketoconazole prescribed to treat a fungal infection of the nails. See the full Drug Safety ... Read more
Related support groups: Ketoconazole, Tinea Corporis, Onychomycosis - Toenail, Tinea Cruris, Diaper Rash, Tinea Barbae, Tinea Versicolor, Cutaneous Candidiasis, Nizoral, Onychomycosis - Fingernail, Tinea Pedis, Onychomycosis, Tinea Capitis, Chronic Mucocutaneous Candidiasis, Dermatophytosis, See also Cutaneous Fungal Infections, Cutaneous Sporotrichosis, Chromomycosis, Eumycetoma, Cutaneous Fungal Infection