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FDA issues ketoconazole warning; no longer first-line choice

Ketoconazole oral tablets should no longer be a first-line treatment for fungal infections, according to a warning released today by the FDA.

The FDA took several actions regarding this drug, including limiting the drug’s use; warning that it can cause severe liver injuries and adrenal gland problems; and advising that it can lead to harmful drug interactions with other medications.

“Ketoconazole tablets should be used only for the treatment of certain life-threatening mycoses when the potential benefits outweigh the risks and alternative therapeutic options are not available or tolerated,” according to an FDA MedWatch dispatched today.

Clinicians should assess the liver status of the patient before starting therapy with oral ketoconazole, and serum alanine aminotransferase levels should be monitored during treatment. Adrenal function should be monitored in patients with adrenal insufficiency or with borderline adrenal function and in patients under prolonged periods of stress, including major surgery, intensive care, etc.

All concomitant medications for the potential for drug interactions with ketoconazole tablets should also be reviewed, according to the FDA.

Ketoconazole should be used for the treatment of endemic mycoses only when alternative antifungal therapies are not available or tolerated.