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Itraconazole Antifungal Shows Hepatic Safety

Pulse therapy with the oral antifungal agent itraconazole for onychomycosis appears to be safe. In particular, it does not threaten liver damage, despite some reports of hepatitis.

Researchers at the University of Nevada, Las Vegas, United States, the University of Toronto, Canada, and in France investigated the drug's safety because of the increasing use of newer oral antifungal agents to treat superficial fungal infections.

The researchers noted that itraconazole was effective and well tolerated with mostly minor and reversible side-effects. The most common adverse events were gastrointestinal upset, headache, and transient skin reaction. However, there had been rare reports of hepatitis.

To assess the hepatic safety of pulse and continuous itraconazole, the researchers analysed all itraconazole clinical trials sponsored by Janssen Research Foundation in the treatment of onychomycosis where there had been an assessment of laboratory safety. They also reviewed published literature to assess the hepatic safety of itraconazole in common practice.

The data indicated that itraconazole pulse treatment was safe, The incidence of all code 4 abnormalities was below 2 percent.

There were reports, in the literature, of symptomatic hepatitis with itraconazole continuous therapy but none of symptomatic hepatotoxicity with the pulse regimen.

The researchers pointed out that in the itraconazole package insert, liver function tests were recommended for patients receiving continuous itraconazole for more than one month. There was no such monitoring requirement for the pulse regimen unless the patient had a history of underlying hepatic disease or if the liver function tests were abnormal at baseline or at any time when signs or symptoms suggested liver dysfunction.
Journal of Cutaneous Medicine and Surgery 2002;DOI:10.1007 s10227-001-0048-3 "Hepatic Safety of Itraconazole"

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