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.
close

Next Article in News

Email Newsletters

More in News

Amgen sends PCSK9 to FDA

Amgen sends PCSK9 to FDA

Evolocumab holds the FDA's first filed biologics license application for the class.

Consultants expect M&A tempo to continue

Consultants expect M&A tempo to continue

PwC anticipates that divestitures will fuel late-2014 deals, but notes that the noise around early deals and the financials don't fully match up.

Five things for Pharma Marketers to Know: Thursday, August 28

Five things for Pharma Marketers to Know: Thursday, ...

Human testing of GSK's Ebola virus starts next week, menopause is a costly healthcare concern, and a small conversation with pharmacists may have a big impact.