Sporonox and Lamisil for the Treatment of Onychomycosis

Sporanox and Lamisil
Public Health Advisory

The FDA issued a Public Health Advisory to announce important safety-related updates to the labeling of Sporanox® (itraconazole) and Lamisil® (terbinafine hydrochloride) Tablets.

FDA is advising healthcare professionals not to prescribe Sporanox® to treat fungal infections (onychomycosis) in patients who have congestive heart failure (CHF) or a history of CHF. The updated Sporanox® labeling also includes contraindications and precautions with certain medicines.

• FDA Talk Paper (5/9/2001)

• FDA Public Health Advisory (5/9/2001)

• Questions and Answers (5/9/2001)

• Letter to Health Care Professionals-Lamisil  (Medwatch)  (5/11/2001)

• Letter to Health Professionals-Sporanox  (Medwatch) (5/9/2001)

• Revised Labeling - Sporanox Capsules  (5/9/2001)

• Revised Labeling - Lamisil Tablets  (5/9/2001)