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FDA Limits Usage of Nizoral (ketoconazole) Oral Tablets due to Potentially Fatal Liver Injury and More

FDA limits usage of Nizoral (ketoconazole) oral tablets due to potentially fatal liver injury and risk of drug interactions and adrenal gland problems

On July 26th, 2013 the U.S. Food and Drug Administration (FDA) took 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. The FDA has approved label changes and added a new Medication Guide to address these safety issues.

As a result, 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. In the revised US drug label, indications for dermatophyte and Candida infections have been removed and the indications for treatment of endemic mycoses: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis have been retained only for patients in whom other antifungal treatments have failed or are not tolerated

The topical formulations of Nizoral have not been associated with liver damage, adrenal problems, or drug interactions. These formulations include creams, shampoos, foams, and gels applied to the skin, unlike the Nizoral tablets, which are taken by mouth.

The 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. The FDA will continue to evaluate the safety of Nizoral tablets and will communicate with the public again if additional information becomes available.

 

More information about this announcement is available on the FDA Web site at http://www.fda.gov/Drugs/DrugSafety/ucm362415.htm.

To report problems with ketoconazole tablets, contact MedWatch, the FDA’s safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

 

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