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Important Drug Warning - Lamisil - (terbinafine HCL) - Novartis

Date: 2001-05-17

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IMPORTANT DRUG SAFETY INFORMATION

May 17, 2001

Dear Health Professional,

Novartis Pharmaceuticals Canada Inc. would like you to be aware of the following information for LAMISIL*(terbinafine HCl) Tablets. As stated in the Precautions and Dosage and Administration sections of our current Product Monograph for LAMISIL, the tablet dosage form should not be prescribed for patients with pre-existing liver disease. The statements appearing in the Product Monograph are being revised to provide more detailed information regarding the use of Lamisil tablets in patients with liver disease.

1. Rare cases of hepatic failure, some leading to death or liver transplant, have occurred with the use of LAMISIL (terbinafine HCl) Tablets for the treatment of onychomycosis and dermatomycosis in individuals with and without pre-existing liver disease. As of April 2001, based on a Public Health Advisory issued in the U.S., there have been 16 possible Lamisil-associated cases of liver failure, reported worldwide, including 11 deaths and two liver transplantations. In the majority of liver cases reported in association with LAMISIL use, the patients had serious underlying systemic conditions and an uncertain causal relationship with LAMISIL. Although ongoing post-marketing surveillance and clinical trials have shown no increase in the frequency of these adverse events, it is important to reinforce the need for proper patient selection when considering treatment with LAMISIL Tablets. In response to these rare cases from post-marketing surveillance, Novartis Pharmaceuticals Canada Inc. is revising the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the Product Monograph. Most important for the prescriber is the following revised statement under PRECAUTIONS: "Lamisil is not recommended for patients with chronic or active liver disease. Before prescribing Lamisil Tablets, pre-existing liver disease should be assessed. Hepatotoxicity may occur in patients with and without pre-existing liver disease. Pretreatment serum transaminase (ALT and AST) tests are advised for all patients before taking Lamisil Tablets. Patients prescribed Lamisil (terbinafine HCl) Tablets should be warned to report immediately to their physician any symptoms of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain, or jaundice, dark urine or pale stools (see WARNINGS). Patients with these symptoms should discontinue taking oral terbinafine, and the patients' liver function should be immediately evaluated."
   
   
2. Novartis Pharmaceuticals Canada Inc. also wishes to take this opportunity to outline the information contained in the PRECAUTIONS-Drug Interactions section of the current Product Monograph. Both in vitro and clinical studies have shown that terbinafine is a potent inhibitor of the ethnically polymorphic CYP 2D6 isoenzyme, which is responsible for the metabolism of a wide variety of drugs. Caution should be exercised in patients receiving concomitant therapy with drugs metabolized by CYP 2D6, especially those with a narrow therapeutic window.

original signed by

Pier-Giorgio Fontana, PhD
Vice-President, Drug Regulatory Affairs

original signed by

Beat Sümegi, MD
Vice-President, Medical

* Lamisil is a registered Trademark of Novartis Pharmaceuticals Canada Inc.