AUSTRALIA The Therapeutic Goods Administration has issued a warning about serious adverse side effects reported with Lamisil, a drug used for ringworm and nail fungal problems, according to published reports.
The medication is commonly prescribed to people who do not respond to topical fungal creams, but the regulator’s Adverse Drug Reactions Advisory Committee warns it can cause liver failure.
The committee has received 722 adverse event reports related to Lamisil, known generically as terbinafine, including 70 liver reactions, 61 implicating the tablet form as the sole suspected drug.
“Most of the reports document minor abnormalities of liver function but three describe fatal liver failure, 10 describe hepatitis, and 12 describe jaundice,’’ the committee’s latest drug reactions bulletin states.
The committee warned prescribers that the oral formulation should only be prescribed short-term and as a last resort. A spokesman for the drug’s manufacturer, Novartis, said that serious and life-threatening liver reactions were rare and well documented side effects of oral anti-fungal medications.