FDA issues safety warning for antifungal medication

The U.S. Food and Drug Administration recently released a safety warning about oral ketoconazole for patients with fungal infections. The tablets, known commercially as Nizoral, have been found to cause severe liver injuries and adrenal gland problems.¹

Based on the FDA warning and the availability of alternative treatments, Providence Health Plan will remove oral ketoconazole from the formulary and add prior-authorization criteria. Here are some highlights from the FDA advisory:

  • Oral ketoconazole should not be used as a first-line agent for any fungal infection. Its use should be limited to life-threatening endemic mycoses infections (caused by blastomycosis, chromoblastomycosis, coccidioidomycosis, histoplasmosis and paracoccidioidomycosis) in patients who can’t tolerate first-line therapies.
  • Formulary alternatives to oral ketoconazole include fluconazole, itraconazole and voriconazole, depending on the specific mycosis.
  • Ketoconazole tablets are contraindicated in patients with acute or chronic liver disease.
  • Serious liver damage has occurred in patients receiving high doses of oral ketoconazole for short periods of time as well as those receiving low doses for long periods.
  • Oral ketoconazole may cause adrenal insufficiency. Monitoring of adrenal function is recommended in patients at high risk for adrenal problems.

This safety warning does not apply to topical ketoconazole.

If you have any questions or concerns, please contact Providence’s regional pharmacy department at 503-574-7400.

¹U.S. Department of Health and Human Services FDA Drug Safety Communication: “FDA limits usage of Nizoral (ketoconazole) oral tablets due to potentially fatal liver injury and risk of drug interactions and adrenal gland problems.” Silver Spring, Md.; U.S. Food and Drug Administration, 2013