The FDA has recently issued a Drug Safety Communication to notify the public and healthcare professionals about new limitations regarding ketoconazole oral tablets. These limitations include severe hepatotoxicity, potential drug interactions, and adrenal insufficiency. The ketoconazole label has been changed to include these new limitations. New patient Medication Guide was approved and mandated with every prescription. These changes were exclusive for the oral form and did not include topical ketoconazole. Currently oral ketoconazole is only indicated for serious life threatening fungal infections when other treatments have failed or cannot be tolerated. FDA also provides many new instructions for healthcare providers who will prescribe ketoconazole. How quickly do most FDA Drug Safety Communications affect your practice?
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