Lamisil®
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.
More Information
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.
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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