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On May 9, 2001. The Food and Drug
Administration (FDA) issued a Public Health Advisory to announce significant
safety-related updates to the labeling of Lamisil tablets and Sporanox products.
Lamisil and Sporanox are used to treat nail (onychomycosis), skin and other
systemic fungal infections.
Potential Liver Damage
This FDA warnings alerts healthcare
professionals to rare cases of serious liver problems including liver failure,
transplantation and death associated with the use of Lamisil tablets.
While adverse liver effects were
previously included in the labeling for Lamisil products, the FDA decided to
include this information in the advisory because some cases involved patients
with no preexisting liver disease or any serious underlying medical condition.
As of March 2001, the FDA has
reviewed 16 possible Lamisil associated cases of liver failure, including 11
deaths and two liver transplant patients.
Given the possible serious risks
associated with Lamisil tablets, the new labeling for both products now
recommends that healthcare professionals should obtain nail specimens for
laboratory testing prior to prescribing the medications for fungal nail
infections, to confirm the diagnosis.
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