Tim O'Malley (Limerick East, Progressive Democrats)

I thank Deputy Twomey for raising this issue and I welcome the opportunity to reply. I am well aware of this problem, which has been in the public arena since before the screening of the "Panorama" programme. Unfortunately I did not see that programme but I have discussed it with several members of the expert group which I set up about a year ago to examine the mental health area. That group will examine the issue, on which it has very strong views, and will return to me next year.

The Irish Medicines Board is the statutory body responsible for the regulation of medicinal products in Ireland. It is responsible for monitoring the safety of all medicinal products licensed for use in Ireland and for evaluating all new scientific data that emerge. In consultation with its European colleagues, the IMB has continuously monitored the safety of the class of medicines known as selective serotonin re-uptake inhibitors since they were first licensed for the Irish market several years ago.

The board has taken regulatory action on these products when deemed necessary. Most recently the board took part in a European-wide review of medicinal products containing paroxetine, one of the group of SSRIs used to treat mild to moderate depression and which includes Seroxat. This review was undertaken on the basis of safety concerns relating to these products. The board actively participated in the review, which involved a complete benefit-risk reassessment. The review concluded that the benefit-risk profile of products containing paroxetine remains positive. A number of recommendations were made for inclusion in the products licence documents, the purpose of which was to harmonise the information on these products throughout member states. This documentation includes special warnings and precautions for use, particularly on the need for close monitoring of patients using medicinal products containing paroxetine.

I am informed that the majority of these recommendations are reflected in the licence documentation currently approved in Ireland. These include a warning to reflect that paroxetine should not be used in children and adolescents. In the EU paroxetine is not authorised for use in this population. Data from clinical trials raised concerns regarding suicidal behaviour and hostility. In addition, data from clinical trials have not adequately demonstrated efficacy in these age groups. Although paroxetine is not authorised for use in children and adolescents, doctors can prescribe this product for an individual patient if they feel it may be of benefit. However, they are advised to exercise caution. Alternative treatments for childhood depression such as cognitive behavioural therapy may be prescribed by child psychiatrists.

Prescribers are warned to recommend close monitoring of patients at high risk of suicidal behaviour. These include patients with a known history of suicidal behaviour or suicidal thoughts prior to starting treatment and possibly young adults. There is also a recommendation that prescribers and patients should be warned regarding the occurrence of withdrawal reactions on stopping treatment. Generally, these are mild to moderate and self-limiting. However, in some patients they may be severe and-or prolonged.

Following a review of the existing data on paroxetine by medical experts from the member states, these recommendations were issued. Ireland — via the IMB and its national experts — participated in this review and I am advised these recommendations are considered appropriate on the basis of the data assessed. The committee for human medicinal products, a scientific committee of the EMEA, will take further action on paroxetine if new data emerge which indicate that this is necessary. This committee is currently considering a review of all the other SSRIs and related anti-depressants and I understand a review of these issues is also ongoing in America.

The Deputy will appreciate that the full safety profile of a medicine only becomes apparent after long-term and widespread use. As regards medicines used in the treatment of psychiatric disorders, it may be particularly difficult to distinguish between the underlying condition and the possible effects of new treatment. These issues are under continuous review by the Irish Medicines Board and its European counterparts. The Deputy may rest assured that my Department, which is continually monitoring the situation, will take any further regulatory action deemed appropriate.

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