The Agency of Medicines and Medical Devices recommended the doctors not to prescribe drugs containing ketoconazole for oral administration for treating fungal infections. The patients treated with ketoconazole are urged to go to the doctor and discuss appropriate treatment alternatives, IPN reports.

According to a communiqué from the Agency, the recommendations were made after France decided to suspend the sale of pills with ketoconazole. The competent French body reached the conclusion that the benefit-risk relation in the case of this category of drugs is negative owing to the high level of associated hepatic damage. In this connection, the European Medicines Agency ordered withdrawing the authorizations for selling such pills.

The Agency of Medicines and Medical Devices specifies that the creams, unguents and shampoos containing ketoconazole can be used in continuation as the quantity of this substance absorbed by the body is very low. The pills containing ketoconazole, which are authorized at EU level by national procedures, are sold under different commercial names, including Nizoral and Fungoral.