LAMISIL

What is Lamisil?

Lamisil, also known as Terbinafine, is in a class of medications called antifungals. It is prescribed to treat fungal infections of the fingernail and toenail and works by stopping the growth of the fungi.

Lamisil Concerns:

Rare cases of liver failure, some leading to death or liver transplant, have occurred with the use of Lamisil. Hepatoxicity may occur in patients with and without pre-existing liver disease. There have also been isolated reports of serious skin reactions
  
Important Signs and Symptoms:

Tell your doctor if any of these symptoms are severe or do not go away:
 upset stomach, stomach pain, right upper abdominal pain
 diarrhea
 rash, hives, itching
 change in taste or loss of taste

Call your doctor immediately if you experience any of these potentially serious side effects:
 dark urine
 pale feces
 loss of appetite, vomiting, upset stomach that does not go away
 extreme tiredness
 severe skin rash that worsens
 fever, sore throat and other signs of infection

FDA Warnings:

As of March 2001, the FDA had reviewed a number of possible Lamisil-associated cases of liver failure, including two that required liver transplants and another 11 ending in death. Given the possible serious risks, new labeling recommended that healthcare providers perform testing to confirm the diagnosis, prior to prescribing the drug.

On May 9, 2001 the FDA issued a Public Health Advisory to announce significant safety-related updates to the labeling of Lamisil tablets.

James R. Keller
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Partner at Keller & Keller