FDA Announces Safety Measures To Address Risks of Nizoral Tablets

The antifungal drug Nizoral (ketoconazole) tablets should not be a first-line treatment for any fungal infection, the Food and Drug Administration said July 26 in announcing several safety actions to address the drug’s risk.

FDA warned that the drug can cause severe liver injuries and adrenal gland problems and advised that it can lead to harmful interactions with other medications. FDA also said it had approved label changes and added a new medication guide to address these safety issues.

The tablets are sold in generic form, an FDA representative told BNA. Janssen, part of Johnson & Johnson, had the new ...