Lamisil

(Terbinafine HCL)(TABLET FORM ONLY)

History and Background

Novartis Pharmaceuticals Corporation distributes Lamisil, the brand name for Terbinafine Hydrochloride, for the treatment of nail, skin and other systemic fungal infections. It is primarily used to treat a form of fungal infection of the nail called Onychomycosis. This fungal infection of the nail aggressively discolors, thickens, and destroys the nail plate. It is estimated that 10 million individuals in the continental United States suffer from Onychomycosis. The high-risk groups for this fungal infection are the elderly, immuno-compromised, and diabetic patients.

Problems With Lamisil

The Food and Drug Administration (FDA) has recently issued a safety advisory for the drug Lamisil. There are serious risks associated with this drug. These recent warnings do not apply to the topical applications of the drug Lamisil. The safety advisories issued by the FDA in April 2001 only apply to the Lamisil tablets. As of April 2001 the FDA has received and reviewed 16 possible Lamisil associated cases of liver failure, including 11 deaths and two liver transplants. As a result, the FDA has not only issued the advisory, but has also ordered new labeling and that the drug company send letters to physicians regarding the new precautionary measures. The FDA has suggested that health care professionals obtain nail specimens and conduct laboratory testing to confirm their diagnosis, prior to prescribing Lamisil.

Lamisil was approved in May 1996. As of October 2001 Lamisil has not been recalled by the FDA and is still marketed by Novartis Pharmaceuticals Corporation.

Legal Issues Surrounding Lamisil:

Lamisil, also known as Terbinafine Hydrochloride, has been associated with serious liver problems resulting in liver failure or death. Patients who are considered potential users Lamisil should be pre-screened for any existing liver disease prior to actually being prescribed the drug. Patients who are currently prescribed Lamisil or who have taken Lamisil should watch for symptoms of liver failure: nausea, vomiting, abdominal pain, fatigue, loss of appetite, dark urine, and generalized skin discoloration.

Prescription Errors:

In addition to the severe reactions associated with the use of Lamisil, there have also been reports that prescribing and dispensing errors have occurred. These errors have occurred with such drugs as Lamictal, an anti-epileptic medication.

Reported Side Effects of Lamisil:

� Dark Urine Rash

�Abdominal Pain
         � Diarrhea
         � Fatigue
         � Flu-like symptoms
         �Hair Loss
         �Headaches
         � Hives
         � Indigestion
         � Itching
         � Jaundice
         � Joint pain
         � Liver enzyme abnormalities
         � Loss of appetite
         � Muscle aches
         � Nausea
         � Seizures
         � Skin discoloration
         � Strokes
         � Taste Disturbance
         � Vision Problems
         � Vomiting
         � Yellowing of the Eyes

Lamisil May Have Adverse Effects When Used in Combination with:

� Cimetidine (Tagment)

� Cyclosporine (Neoral, Sandimmune)

� Rifampin (Rifadin, Rimactane)

(Tablet Form Only)