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 Sporanox products and Lamisil tablets. Sporanox and Lamisil are used to treat nail (onychomycosis), skin and other systemic fungal infections.

Potential Heart Damage

The FDA believes there is real risk of developing congestive heart failure (CHF) associated with the use of Sporanox. Both Sporanox and Lamisil have been associated with serious liver problems resulting in liver failure, transplantation and even death.

Results of recent studies of Sporanox showed that the drug can weaken the force of the heart muscle's contractions. This condition, sometimes called "negative inotropic effect" was observed when Sporanox was injected intravenously into anesthetized dogs and healthy human volunteers. In these studies, the adverse effect on the heart muscle resolved once the drug was stopped.

Since becoming aware of the study findings, the FDA analyzed US and international post-marketing adverse event reports involving Sporanox that were received between its approval in September 1992 and April 2001.

During this period, FDA received the following event reports:

In response to the study findings and the analysis of the post-marketing adverse event reports, the FDA has added additional information to the current warning in the Sporanox labeling. The warning now states that Sporanox should not be administered for the treatment of fungal nail infections in patients with evidence of cardiac dysfunction, such as CHF, or a history of CHF.

The revised Sporanox warning also includes important information about heart-related adverse events caused by drug interactions. If signs and symptoms of CHF occur during treatment of fungal nail infections, the revised labeling recommends that the use of Sporanox should be discontinued.

Potential Liver Damage

The advisory also alerts healthcare professionals to rare cases of serious liver problems including liver failure, transplantation and death associated with the use of Sporanox products and Lamisil tablets.

While adverse liver effects were previously included in the labeling for both 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, FDA has received and reviewed 24 cases of liver failure possibly associated with Sporanox, including 11 deaths. In almost half of the liver failure cases, subjects received Sporanox for fungal nail infections or other dermatological infections.

Given the possible serious risks associated with Sporanox products and 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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