Ketoconazole Drug Safety Communication

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Potentially Fatal Liver Injury, Risk of Drug Interactions and Adrenal Gland Problems

USFDA is taking several actions related to Ketoconazol oral tablets, 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. FDA has approved label changes and added a new Medication Guide to address these safety issues. As a result, Ketoconazol oral tablets should not be a first-line treatment for any fungal infection. Ketoconazol should be used for the treatment of certain fungal infections, known as endemic mycoses, only when alternative antifungal therapies are not available or tolerated.

 Liver Injury (Hepatotoxicity)

Ketoconazole tablets can cause liver injury, which may potentially result in liver transplantation or death.  FDA has revised the Boxed Warning, added a strong recommendation against its use (contraindication) in patients with liver disease, and included new recommendations for assessing and monitoring patients for liver toxicity.

 Adrenal Insufficiency

Ketoconazole tablets may cause adrenal insufficiency by decreasing the body’s production of corticosteroids.

 Drug Interactions

Ketoconazole tablets may interact with other drugs a patient is taking and can result in serious and potentially life-threatening outcomes, such as heart rhythm problems.

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