FDA Issues Warning on Fungus Drugs
The Food and Drug Administration issued a health warning Wednesday about potential problems associated with two drugs widely used to treat fungal infections of the nails and skin.
The FDA is requiring that labels for the prescription drugs Sporanox and Lamisil carry stronger warnings about potential liver damage, and labels for Sporanox also cite potential heart damage.
The new labeling for both drugs strengthens current warnings of serious liver problems, including liver failure and death, associated with Sporanox products and Lamisil tablets. The warnings do not apply to the cream or solution versions of Lamisil.
The agency said it has reviewed 16 possible Lamisil-associated cases of liver failure, including 11 deaths, and 24 cases of liver failure possibly associated with Sporanox, also including 11 deaths.
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