asked the Minister for Health if he has been in contact with the National Drugs Advisory Board about the drug Ketoconazole which is sold in Ireland under the brand name Nizoral as this has been the cause of five deaths in Britain and 77 cases of liver damage have been reported after the oral preparation of the drug had been used there and if he will make a statement on the matter.
Ceisteanna—Questions. Oral Answers. - Use of Drug.
14.
I have been in contact with the National Drugs Advisory Board regarding the product mentioned by the Deputy. The board are aware of the possible adverse effects from the use of Nizoral, particularly during prolonged treatment. They have alerted all medical practitioners that systemic use of Nizoral be reserved for the treatment of serious or intractable infections which do not respond to topical measures. The NDAB said also in their warning letter to medical practitioners that systemic treatment involving Nizoral is best carried out in hospital and under consultant supervision with regular assessment of liver function. The board are keeping the matter under constant review.
Has the Minister any evidence that this drug has caused death or liver damage in this country?
I have not had any such report. Earlier this month there were Press reports confirming death and liver damage in the UK as a result of the use of the drug. I have received an indication from the National Drugs Advisory Board that there were two cases in Ireland where liver function was reported to have been affected following the use of this drug. In one of the cases the patient was suffering from an infection of the lung and he died.
Will the Minister say what tests were done on the drug before it was allowed to be used here by the National Drugs Advisory Board?
The particular product authorisation was granted to a pharmaceutical company on 26 November 1981 on the recommendation of the National Drugs Advisory Board. The authorisation included precautions and warnings in regard to the use of the product and in particular the need for regular liver function tests during prolonged treatment. I might add that in the case of the patient who died that death could not be attributed to the use of the drug. Following reports of the deterioration of liver function in patients arising out of this therapy, the authorisation was amended in March 1984 on the advice of the National Drugs Advisory Board to include further precautions and warnings.
Will the Minister inform the House of the exact tests done in this country before the drug was allowed into use? If the tests were not carried out here, will he give details of the research and tests done abroad?
I do not have the precise information requested by the Deputy. However, I shall inquire from the National Drugs Advisory Board regarding those tests and I will write to the Deputy in that connection.
The remaining questions will appear on tomorrow's Order Paper.