The Food and Drug Administration (FDA) is taking several actions to limit the use of the oral, anti-fungal medication Nizoral (ketoconazole) tablets, warning that the drug can cause potentially fatal liver injuries and adrenal gland problems, and advising that it can have harmful interactions with other medications.
The FDA is advising that Nizoral oral tablets not be a first-line treatment for fungal infections. The drug should be used for certain fungal infections, known as endemic mycoses, only when alternative anti-fungal therapies are not available or tolerated by the patient.
Nizoral tablets are indicated for the following systemic fungal infections: candidiasis, chronic mucocutaneous candidiasis, oral thrush, candiduria, blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. The tablets should not be used for the treatment of fungal meningitis because the medication penetrates poorly into the cerebral-spinal fluid.
The medication also does not treat the type of fungal infections caused by contaminated steroid shots made by New England Compounding Center (NECC), which led to the recent multistate fungal meningitis outbreak.
The FDA is warning that Nizoral tablets have been found to cause liver injury, which could result in liver transplantation or death, and thus has revised the drug’s black box warning to strongly recommend against its use in patients with liver disease, and to recommend assessing and monitoring patients for liver toxicity.
The agency is also warning that the drug can cause adrenal insufficiency by decreasing the body’s production of corticosteroids. Also, the drug may interact with other medications the patient is taking, which can result in serious and potentially life-threatening outcomes including heart rhythm problems.
Nizoral also comes in topical formulations including creams, shampoos, foams, and gels. None of the topical formulations have been associated with liver damage, adrenal problems or drug interactions.
Patients with questions about their anti-fungal medication should consult with their doctors. Any side effects with Nizoral should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.