FDA Safety Alert:
Ketoconazole is a medication used to treat fungal infections in
pill and topical formulation. The safety advisory below from the Food
and Drug Administration is intended to notify medical providers that
ketoconazole (brand name-Nizoral) in pill form should NOT be given to
anyone with liver disease. In addition, everyone (even those without
liver disease) should be monitored while on therapy due to the potential
toxicities and drug-drug interactions. The topical forms do not seem
to cause liver damage. Please share this important information with
others that you know have liver disease. -AF
AUDIENCE: Internal Medicine, Infectious Disease
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. 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
Liver Injury (Hepatotoxicity)
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.
Nizoral tablets may cause adrenal insufficiency by decreasing the body’s production of corticosteroids.
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.
See the FDA Drug Safety Communication for additional information, including a Data Summary.
Nizoral (ketoconazole) is indicated for the treatment of fungal
infections when alternatives are not available or 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.
Nizoral tablets should be used only for the treatment of certain
life-threatening mycoses when the potential benefits outweigh the risks
and alternative therapeutic options are not available or tolerated.
Healthcare professionals should assess the liver status of the patient
before starting oral ketoconazole, and monitor serum ALT levels during
treatment. Adrenal function should be monitored in patients with adrenal
insufficiency or with borderline adrenal function and in patients under
prolonged periods of stress (major surgery, intensive care, etc.).
Review all concomitant medications for the potential for drug
interactions with Nizoral tablets.
Healthcare professionals and
patients are encouraged to report adverse events or side effects related
to the use of these products to the FDA's MedWatch Safety Information
and Adverse Event Reporting Program:
[07/26/2013 - Drug Safety Communication - FDA]
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form
or call 1-800-332-1088 to request a reporting form, then complete and
return to the address on the pre-addressed form, or submit by fax to
[07/2013 - Nizoral (ketoconazole) Prescribing Information]
Labels: FDA Warning, fungal infections, Nizoral (ketoconazole)