asked the Minister for Health the measures being taken to ensure that the drug Debendox is safe for human consumption.
15.
Ceisteanna—Questions. Oral Answers. - Debendox Drug.
14.
asked the Minister for Health if the use of the drug Debendox in the Republic is permissible.
With the permission of the Ceann Comhairle, I propose to take Questions Nos. 14 and 15 together.
Debendox is at present available without prescription in this country. The National Drugs Advisory Board review periodically the safety of drugs marketed here. Debendox was included in a group of products to be reviewed at April 1979 and the board have been in correspondence with the manufacturers on it since. I understand the board are considering new recommendations on the availability of the drug and I expect its advice in the matter very shortly.
In view of the controversial nature of this drug and the fact that it is only taken by women in the early stages of pregnancy when the baby is most at risk of deformity, would the Minister not consider that a special publicity campaign should be launched against the use of drugs in early pregnancy because of the danger of mentally and physically handicapped children being born and also in view of the fact that there was such controversial evidence in the case in Florida? It is a very serious matter and the National Drugs Advisory Board should not be too willing to say that they are satisfied that this is a safe drug because nobody can be satisfied that it is safe. This drug can cause serious congenital defects in babies.
I have every confidence in the board and they will give their report in the matter shortly. On the basis of the various sources available short term to the board, the board is in a position to say that there is no significant evidence that Debendox has produced any adverse effects. It is of interest to note that, according to press reports of 2 April 1980, the British Committee on Safety of Medicines, which corresponds to our National Drugs Advisory Board, have reported to the Health Minister that "it could find no scientific evidence to show that Debendox was the cause of congenital abnormalcies and saw no reason to revoke or suspend the drug's licence or to restrict its availability". At this stage I shall await the recommendations of our board. I am certain that if they felt there was an immediate, urgent need they would have communicated that to us.
I accept that the Minister must be guided by the National Drugs Advisory Board. Because of the fact that the drug is available without prescription and also because the Minister says that there is no significant evidence—that suggests that there is some evidence—I think there is a serious responsibility on the Minister's Department to curtail the free availability of this drug.
I shall have to curtail the Deputy.
May I say in conclusion that this is obviously one of the factors that the board would take into consideration?
They said the very same thing about Thalidomide, that there was no evidence to suggest that it caused congenital defects. We know the international disaster that resulted and in view of that I think there should be greater caution. I am not blaming the Minister.
The matter of freedom of availability is one of the questions that I am quite certain the board would take into consideration and the fact that it is available without prescription.
They are very slow to do it.
I also happen to be a doctor and I have been prescribing Debendox for the last 20 years and I have never seen any reaction other than maternity-wise. Availability, I would suggest, should be on prescription.
I shall certainly convey the views of the two distinguished doctors to the board and I am sure they will consider them seriously. I think they have made reasonable points.