Lamisil & Sporanox

On May 9th, 2001, the Food and Drug Administration (FDA) issued a public health advisory concerning Sporanox® Capsules and Lamisil® Tablets, warning users about the association of these drugs with congestive heart failure (CHF) and liver damage. Sporanox® Capsules and Lamisil® Tablets are synthetic antifungal agents approved in the United States for the treatment of onychomycosis, a fungal nail infection which infects the feet and toenails, and some other fungal infections

The FDA received 94 United States and international reports of CHF in which itraconazole was listed as a suspect drug. In 62 % of the cases, the FDA believes itraconazole contributed to or may have been the cause of the CHF. In the cases where itraconazole was suspected as the sole or contributing cause of the CHF, 48% were hospitalized. 22% of the cases resulted in death of the patient.

Given the risks associated with both drugs, new labeling for both Sporanox® and Lamisil® recommends that healthcare providers obtain nail specimens for laboratory testing prior to prescribing the medications for onychomycosis to confirm the diagnosis.

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