Advisory for Fungal Drugs

FDA Consumer, July, 2001

The FDA has issued a health advisory to announce serious risks associated with the use of Sporanox (itraconazole) products and Lamisil (terbinafine hydrochloride) tablets. Sporanox and Lamisil are used to treat nail, skin, and other fungal infections. The FDA's concerns do not apply to the topically applied versions of Lamisil such as cream and solution.

Both Sporanox and Lamisil have been associated with serious liver problems resulting in liver failure, the need for transplantation, and death. The FDA also believes there is a small but real risk of developing congestive heart failure associated with the use of Sporanox.

The agency has added new information to the labeling for Sporanox, now stating that Sporanox should not be given to treat fungal nail infections in patients with evidence of cardiac dysfunction. The Sporanox warning also includes important information about heart-related adverse events caused by drug interactions.

Given the possible serious risks associated with Sporanox products and Lamisil tablets, the new labeling for both now recommends that health-care professionals obtain nail specimens for laboratory testing to confirm the diagnosis before prescribing the medications for fungal nail infections.

The FDA encourages patients and health-care professionals to report adverse events associated with Sporanox and Lamisil to the FDA's MedWatch program. Reports may be submitted by phone at 1-800-332-1088, by fax at 1-800-332-1078, by mail to MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.>

COPYRIGHT 2001 U.S. Government Printing Office

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