Anti-fungal tablet linked to liver deaths

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Anti-fungal tablet linked to liver deaths

Melbourne Herald Sun - Australia*

By Tamara McLean

February 04, 2008

http://www.news.com.au/heraldsun/story/0,21985,23159050-662,00.html

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.

" Oral terbinafine should be prescribed only after topical therapy

has failed and for the shortest time possible, in accordance with

the current product information.''

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.

The company said it agreed with the advice issued by ADRAC.

Meanwhile, the committee also received 12 reports of reactions in

patients taking both the blood-thinning drug warfarin and anti-

arthritis supplement glucosamine.

It appeared some complementary medications could increase the

activity of warfarin, the bulletin stated.

The committee recommended that patients on warfarin have their blood

tested within a few days of starting or changing the dose of a

complementary medicine.