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Manufacturer: Glaxo Wellcome Inc.
Uses: Sporanox® Capsules and Lamisil® Tablets are prescription medicines approved to treat toe and finger nail fungal infections. Sporanox® Capsules, Oral Solution, and Injection are also approved to treat serious fungal infections that may occur in other parts of the body.
Lamisil® is also available as cream and solution.

Lamisil Tablets

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's advisory also alerts the public that both Sporanox® and Lamisil® Tablets have been associated with serious liver problems including liver failure and death.

As of March 2001, the FDA has reviewed 24 cases of liver failure possibly associated with Sporanox® use, including 11 deaths.
As of April 2001, FDA has reviewed 94 cases in which Sporanox® treated patients developed congestive heart failure. In 58 of the 94 cases, FDA believes Sporanox® contributed to or may have been the cause of the congestive heart failure. Although the causal relationship is unclear, death was reported in 13 cases.
As of April 2001, the FDA has reviewed 16 possible Lamisil® associated cases of liver failure, including 11 deaths and two liver transplant patients.

Some warning signs of congestive heart failure:

Shortness of breath

Swelling of the feet, ankles, legs, or abdomen

Weight gain

Unusually tired

Coughing up of white or pink mucous

Unusual fast heartbeats

Some warning signs of liver failure:

Nausea

Vomiting

Abdominal pain

Fatigue

Loss of appetite

Dark urine

Generalized skin discoloration

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