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Shezad Malik MD JD
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FDA: Nizoral Liver Failure Warning

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FDA issued a  safety warning on July 26, regarding the use of the antifungal medication, Nizoral (ketoconazole). FDA limits usage of Nizoral (ketoconazole) oral tablets due to potentially fatal liver injury and risk of drug interactions and adrenal gland problems. Nizoral is manufactured by Johnson and Johnson.

dallas_dangerous_drugs_attorneyThe U.S. Food and Drug Administration (FDA) is taking several actions related to Nizoral (ketoconazole) 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.

According the FDA warning, Nizoral oral tablets should not be a first-line treatment for any fungal infection. Nizoral 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)

Nizoral 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.

Serious liver damage has occurred in patients receiving high doses of Nizoral for short periods of time as well as those receiving low doses for long periods. Some of these patients had no obvious risk factors for liver disease. The liver injury is sometimes reversible upon stopping the drug, but that is not always possible.

Adrenal Gland Problems (Adrenal Insufficiency)

Nizoral tablets may cause adrenal insufficiency by decreasing the body’s production of hormones called corticosteroids. Health care professionals should monitor adrenal function in patients taking Nizoral tablets who have existing adrenal problems or in patients who are under prolonged periods of stress such as those who have had a recent major surgery or who are under intensive care in the hospital.

Drug Interactions

Nizoral 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.

In summary, the drug label for Nizoral tablets has been updated to include the following information:

• Limitation of the usage of Nizoral tablets by removing indications in which the risk outweighs the benefits. The use of ketoconazole tablets in Candida and dermatophyte infections is no longer indicated. Nizoral tablets should be used only when other antifungal drugs are not available or tolerated by the patient.

• Nizoral tablets are indicated only for the treatment of the following fungal infections: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis in patients in whom other treatments have failed or who are intolerant to other therapies.

• Nizoral tablets are not indicated for the treatment of fungal infections of the skin or nails.

• A new contraindication that Nizoral tablets should not be used in patients with acute or chronic liver disease.

• Updated information on the risk of liver injury, or hepatotoxicity, with new assessment and monitoring recommendations.

• Updated information on drug interactions.

• A warning regarding adrenal insufficiency with recommendations for monitoring populations at risk.

FDA has also approved a new patient Medication Guide containing information on the potential risks associated with Nizoral tablets, which must be dispensed with every prescription for the drug.

• During 2012, approximately 5.2 million ketoconazole prescriptions were dispensed, of which 609,000 (12%) were for the tablet formulation.