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Lamisil® Lawsuit | Lamisil Lawyer | Lamisil Liver Failure | Lamisil Death

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.

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.

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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.

Side Effects

• 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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