May 9, 2001 - Public Health Advisory: Novartis Pharmaceutical

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The Novartis Pharmaceuticals Corporation (NPC) has revised the "PRECAUTIONS" section of the drug's label to inform patients that: "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 patient's liver function should be immediately evaluated." The "WARNINGS" and "ADVERSE REACTIONS" labels have also undergone some significant changes. These changes took place after the company had conducted research of the drug and concluded that Lamisil (terbinafine HCI) tablets should not be prescribed to patients with pre-existing liver disease.

The NPC notes that there is a possible causal connection between taking Lamisil tablets by patients with pre-existing liver conditions for onychomycosis and serious liver complications. Although this research is still uncertain, NPC nevertheless made the labeling changes to assure that the drug is prescribed to the right patients.

The label now reads that: "In vitro studies have also shown that terbinafine inhibits CYP2D6-mediated metabolism. This may be of clinical relevance for compounds predominantly metabolized by this enzyme, such as tricyclic antidepressants, ß-blockers, selective serotonin reuptake inhibitors (SSRIs), and monoamine oxidase inhibitors (MAO-Is) Type B, if they have a narrow therapeutic window."

Novartis further warns doctors and pharmacists not to confuse Lamisil with other phonetically similar drugs, like Lamictal (lamotrigene), a drug used to treat epilepsia.

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