Death Risk With Off-Label Oral Ketoconazole Use, FDA Warns

Disclosures

May 19, 2016

The US Food and Drug Administration (FDA) is warning clinicians against the off-label prescribing of ketoconazole tablets (Nizoral, Janssen Pharmaceuticals) to treat skin and nail fungal infections because the risk for serious liver damage and death outweighs the benefits.

In July 2013, the FDA removed skin and nail fungal infections as indications for ketoconazole tablets in light of possible adverse events, which also include adrenal gland problems and harmful interactions with other drugs. The agency revised the label to warn that patients with no obvious risk factors for liver disease had developed serious hepatotoxicity after taking the drug, leading to liver transplants or death in some cases.

However, clinicians have continued to prescribe ketoconazole tablets for skin and nail fungal infections despite the label change, according to an FDA safety review. Such infections were the only diagnoses cited for the tablets during 2014 and the first 6 months of 2015, according to a database of physician surveys. For the last 12 months of that period, US outpatient retail pharmacies dispensed ketoconazole tablets to roughly 217,000 patients.

The FDA has received one report of a fatality related to oral ketoconazole since July 2013. The patient died of liver failure after taking the tablets for infected nails.

"Healthcare professionals should use ketoconazole tablets only to treat serious fungal infections when no other antifungal therapies are available," the FDA said in a news release. In contrast, skin and nail fungal infections are not life-threatening, so the risks that come with oral ketoconazole outweigh the benefits. Clinicians can turn to other prescription and over-the-counter treatments for these infections.

The FDA notes that topical versions of ketoconazole applied to skin or nails have not been linked to liver damage, adrenal problems, or drug interactions.

More information about today's announcement is available on the FDA website.

To report any 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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