A reassessment has recently been performed, both by the European Medicines Agency and by the U.S. Food and Drug Administration (FDA), of the risk versus the benefit of preparations containing the active ingredient Ketoconazole administered orally.
In Israel, there is a preparation called Nizoral tablets which contains this active ingredient. The preparation has existed for many years, and is administered for the treatment of fungal infections.
In Europe, it has been decided to stop the marketing of the preparation, mainly due to fear of severe liver damage (which could lead to liver transplant and even death). The risk from the administration of this preparation is larger than for other preparations given for the treatment of fungal infections. The assessment in Europe is that there is no indication that justifies the risk of taking the medication.
On the other hand, in the U.S.A., the FDA has limited the registration of the preparation and has taken strict steps, but has determined that the preparations will remain on the market. The FDA has retained the preparations for severe infections which are liable to be life-threatening, only when there is no alternative for treatment, and has also put additional restrictions in place.
In Israel, the registration of the preparation will be canceled, in accordance with what has been done in Europe.
Patients who are taking the preparation must consult with their physician regarding changing the treatment.
There are other appropriate medications for the indications for which the preparation is given.
Use of the preparation will be allowed only for serious indications that are liable to be life threatening, both until stocks of the preparation are exhausted and after this (by special authorization), and only if there are no other treatment options.
Preparations containing Ketoconazole as a cream or shampoo (nizoral cream and nizoral shampoo) will continue to be marketed as usual. Because of the low absorption of these preparations, there is no fear of these side-effects.