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Thursday, 9 March 1972
Page: 589


Senator MURPHY (NEW SOUTH WALES) - Will the Minister for Health tell the Senate what was the result of the meeting of the Australian Drug Evaluation Committee, which 1 understand was held yesterday, in relation to the matter raised by Dr McBride on the possible hazard associated with the drug imipramine and whether some warning should be required in respect of the use of that drug in certain circumstances?


Senator Sir KENNETH ANDERSON

I am grateful for the question being posed because this is a matter of tremendous importance. In anticipation of the matter being raised here today I have prepared - with an economy of words I hope - a response on it. The first thing I would like to do is to seek leave to table a copy of the statement that was released in Sydney last night, I understand, by Sir William Morrow, the Chairman of the Australian Drug Evaluation Committee.


The PRESIDENT - Is leave granted? There being no objection, leave is granted.


Senator Cavanagh - Could it be incorporated in Hansard?


Senator Sir KENNETH ANDERSON - I would be perfectly willing that it be incorporated in Hansard. I think it is quite proper that it should be. 1 seek leave accordingly.


The PRESIDENT - Is leave granted? There being no objection, leave is granted. (The document read as follows) :

At a special meeting of the Australian Drug Evaluation Committee held in Sydney today, Dr William McBride acknowledged to the Committee that his original statements about imipramine were incorrect.

Of the three cases of birth abnormalities to which he had previously referred, only one baby had amelia (total absence of arms) and two others had a less severe degree of abnormality (shorter than normal arms).

The mother of the first of these babies was said to have taken imipramine during early pregnancy; the mothers of the other two children had not taken imipramine but were said to have taken another tricyclic anti-depressant. In none of these cases have full details been made available even now to my Committee.

Without detailed information no meaningful assessment can be made as to whether this, other drugs or other factors are involved.

It is well documented that birth abnormalities of the kind referred to by Dr McBride have occurred as far back as the 19th century - in other words before the advent of modern drugs.

A study of 20,000 others from five teaching hospitals in Sydney and Melbourne over a period of twelve months showed that 159 babieshad been born with limb abnormalities other than congenital dislocation of the hip and club foot. In none of these could tricyclic anti-depressants be invoked as causal agents. These figures are in general agreement with data the Committee has received from other countries such as New Zealand, the United Kingdom, Sweden and Germany. A special study now in progress in Ireland provides further support.

My Committee has knowledge of thirty women in Australia treated with imipramine in early pregnancy in none of whom were foetal abnormalities of any kind recorded. One other case, a condition of excessive bony fragility (osteogenesis imperfecta) occurred. These figures should be seen against background that three babies in every 100 babies born suffer from a major conjenital abnormality from causes unknown.

The Australian Drug Evaluation Committee after a full review of all available information local and overseas can see no reason to alter its previously held views on the use of imipramine during pregnancy. These views were formulated as a result of investigations initiated eighteen months ago into not only imipramine but all anti-depressants. These are as follows:

Safe use of imipramine during pregnancy and lactation has not been established. Therefore, in administering the drug to pregnant patients, nursing mothers or women in child-bearing age the potential benefit must be weighed against the possible hazards.

Animal reproduction studies are inconclusive insofar as only doses which produced toxicity in the mother animal had an adverse effect on the foetus.

There have been clinical reports of congenital malformation associated with the use of this drug but a causal relationship has not been confirmed.

These recommendations are included in draft requirements for the product literature for imipramine, other tricyclic anti-depressants and phenothiazines approved by the Committee at its meeting last December. All manufacturers will be required to include this warning in product literature and a letter to this effect will be circulated to the medical profession. The question of labelling on the container as dispensed was considered by the Committee. This is a complex subject and is being explored in depth.

The events of the past week do serve to emphasise that a great degree of caution is required in the prescription of all drugs during the early stages of pregnancy. Despite the most intensive preclinical testing, it is impossible to predict with absolute accuracy reactions in humans from experimental work with animals.In the use of any drug, the ratio of potential benefit versus possible risk must be carefully weighed. Finally. I 'would emphasise that the Committee has been keeping under close observation the effects of this and other drugs and urges all doctors to report immediately any abnormal reactions.


Senator Sir KENNETH ANDERSON - Honourable senators will be aware that the Australian Drug Evaluation Committe met yesterday to consider information provided by Dr William McBride concerning a possible link between the anti-depressant imipramine and birth abnormalities. In order to assist honourable senators in this matter, Mr President, with your concurrence and with the concurrence of the Senate I have tabled and had incorporated in Hansard a statement that was issued by the Chairman of the Australian Drug Evaluation Committee, Sir William Morrow, following that meeting. I have had discussions this morning with the DirectorGeneral of Health, who was present as an observer during the Committee's meeting, and as soon as question time concludes I will be speaking to him again on this matter. However, 1 should say that at this stage certain actions based on the conclusions reached by the Committee during its meeting have already been decided upon or initiated.

Firstly, cables are to be sent - some have been sent already- to the World Health Organisation and to the health authorities in other countries, . notably the United Kingdom and the United States, informing them of the Committee's report. Secondly, the health authorities in all Australian States have already been notified of the Committee's report. Thirdly, letters will be sent immediately by the Director-General to all Australian doctors, informing them of the Committee's report. This very big task is already in train. Fourthly, a similar letter will be forwarded as soon as possible to the Pharmacy Guild, with a request that information concerning the Committee's report be distributed to all pharmacist members of that Guild. Fifthly, all manufacturers of imipramine and similar antidepressants are being informed of the requirement for the inclusion of appropriate warnings in promotional literature on those products.

It is my belief that honourable senators will obtain whatever information they require from a study of the Committee Chairman's Press statement which I have now tabled and had incorporated in Hansard. However, it might be useful if I were to refer specifically to one of the findings referred to in the statement, namely - and I want to be careful about this because of the way it is expressed:

Safe use of imipramine during pregnancy and lactation has not been established. Therefore, in administering the drug to pregnant patients, nursing mothers or women in child-bearing age the potential benefit must be weighed against the possible hazards.

That is one of the more significant findings of the Committee. I would like to repeat it:

Safe use of imipramine during pregnancy and lactation has not been established. Therefore, in administering the drug to pregnant patients, nursing mothers or women in child-bearing age the potential benefit must be weighed against the possible hazards.

I believe that it also would be useful if I were to point out to honourable senators that the Australian Drug Evaluation Committee is established under Commonwealth legislation and has 7 members, 6 of whom are eminent medical practitioners, including 4 who are specialists in clinical medicine and 2 who are specialists in clinical pharmacology. The seventh member is a professional pharmacologist. Honourable senators will recall that last Tuesday, 7th March, Senator Byrne directed a question to me concerning the general procedures operating within Australia and internationally in the evaluation of drugs and the exchange of relevant information. In reply 1 undertook to provide a paper giving a broad outline of what is done in Australia and internationally concerning this matter. That paper is in the course of preparation. I hope to be able to provide it for the information of honourable senators during the next week of sittings .







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