Popular oral anti-fungal Nizoral barred over fears of organ damage, death

Most active ingredient in well-known anti-fungal banned.

By JUDY SIEGEL-ITZKOVICH
antibiotic 370 (photo credit: Wikimedia Commons)
antibiotic 370
(photo credit: Wikimedia Commons)
The Health Ministry decided to bar the sale of a well-known oral drug for fungal infections after the European Medicines Agency’s Committee on Medicinal Products for Human Use banned its most active ingredient.
The use of Nizoral tablets containing the active substance ketoconazole will be prohibited, the ministry announced on Friday, following the decision by the European committee. Ketoconazole is believed to pose the possibility of serious damage to the liver – even to require a liver transplant – and death.
Other drugs considered less toxic and generally more effective are triazole antifungal agents such as fluconazole and itraconazole, which are usually preferred for internal use.
Nizoral cream and shampoo whose active ingredient is not ingested will be permitted however, the ministry said, because the amount that reaches body systems is minimal.
The Europeans said that “no use of the oral drug justifies the dangers of taking it.”
However, in the United States the FDA did not prohibit the marketing and prescription of the drug, but merely restricted it with the exception of treating severe conditions for which there is no effective alternative medication.
Patients in Israel who have been prescribed oral medications with ketoconazole should consult with their doctors about finding a replacement therapy.
“There are numerous other drugs for the same medical complaints,” the ministry said. Only in rare cases and severe conditions can ketoconazole drugs be allowed, but it will require special approval from the authorities, the ministry said.