The Health Ministry has decided to bar the sale of a common and veteran drug taken orally for fungal infections. The use of oral Nizoral tablets containing the active substance called ketoconazole will be prohibited, the ministry announced on Friday, following a decision to that effect by the European Medicines Agency’s Committee on Medicinal Products for Human Use.
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.
Ketoconazole is now believed to pose the possibility of serious damage to the liver -- even to require a liver transplant -- and death.
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.” In the US, however, the FDA did not prohibit the marketing and prescription of the drug but merely restricted it except for except for treating severe conditions for which there is no effective alternative medication. The Health Ministry decided to follow the path of the Europeans and not the Americans.
Patients in Israel who have been prescribed oral medications with ketoconazole should consult with their doctors about finding a replacement therapy.