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Anti-fungal tablet linked to liver deaths
Three people have died and several others have suffered serious liver reactions after taking a popular tablet to treat fungal infections.
The Therapeutic Goods Administration (TGA) has issued a warning about serious adverse side effects reported with oral Lamisil, a pill formulation for ringworm and nail fungal problems.
The medication is commonly prescribed to people who do not respond to topical fungal creams, but the regulator's Adverse Drug Reactions Advisory Committee (ADRAC) 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.
Those affected ranged from 20 to 85 years old, with half suffering their liver reaction within the first month of taking the pills.
"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.
"Full recovery was noted in 27 reports but 34 cases had not recovered and the outcome remained unknown in nine.''
One case described in the bulletin involved an 81-year-old woman with previously normal liver function.
''(She) developed cholestatic hepatitis some three weeks after commencing oral terbinafine treatment 250mg daily for a fungal infection of the big toe,'' according to the bulletin.
"The patient subsequently died in hepatorenal (liver) failure.''
This is the first ADRAC report linking Lamisil to liver dysfunction, but three others dating as back as far as 1996 have implicated the drug in the blood condition dyscrasia.
The committee warned prescribers that the oral formulation should only be prescribed short-term and as a last resort.
"Doctors prescribing oral terbinafine should be confident there is a clear indication for its use,'' the bulletin states.