Lamisil

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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