Australian regulators issue warning on Novartis' Lamisil

Share this article:
Australia's drug and medical device regulatory agency, the Therapeutic Goods Administration (TGA), has issued a warning concerning nail fungus treatment Lamisil (terbinafine) tablets following reports of three deaths and severe liver reactions among patients. 
The TGA's Adverse Drug Reactions Advisory Committee (ADRAC) received 722 adverse event reports related to Lamisil, including 70 liver reactions, 61 implicating the tablet form as the sole suspected drug.
The committee warned prescribers that the oral formulation of Lamisil should only be prescribed short-term and as a last resort.
“Oral terbinafine should be prescribed only after topical therapy has failed and for the shortest time possible, in accordance with the current product information,” the committee wrote in its drug reactions bulletin.
A spokesman for Novartis said in published reports 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 the ADRAC.
Share this article:
You must be a registered member of MMM to post a comment.

Next Article in Channel


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...