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U.S. Department of Health and Human Services


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Sporanox (itraconazole) May 2001

Lamisil (terbinafine hydrochloride)

FDA is issuing a public health advisory concerning Sporanox and Lamisil, systemic drug therapies to treat onychomycosis (fungal nail infections). Healthcare professionals are notified of the possible association of serious cardiac adverse events with the administration of Sporanox and hepatic adverse events with the administration of both Sporanox and Lamisil. 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. FDA's concerns do NOT apply to the over-the-counter versions of Lamisil, which are topical creams.

[May 11, 2001 - Letter - Novartis Pharmaceuticals Corp.]
[May 09, 2001 - Letter - Janssen Pharmaceutica Products, L.P.]
[May 09, 2001 - Public Health Advisory - FDA]
[May 09, 2001 - Questions and Answers - FDA]
[May 09, 2001 - Revised Sporanox Capsules Label - Janssen Pharmaceutica Products, L.P.]