Dáil Éireann díospóireacht -
Wednesday, 18 Nov 1998

Vol. 496 No. 7

Written Answers. - Medicinal Drugs.

Brian O'Shea

Ceist:

42 Mr. O'Shea asked the Minister for Health and Children his views on recent research linking the use of the acne drug Roacutane to suicidal tendencies; if he will commission any further research on this matter; the plans, if any, he has to ensure that doctors and patients have a greater awareness of the side effects of this drug; and if he will make a statement on the matter. [23933/98]

Pat Rabbitte

Ceist:

70 Mr. Rabbitte asked the Minister for Health and Children if he has satisfied himself that there are sufficient controls over the sale and use of anti-acne preparations in view of strong evidence that some of these may have serious side effects; the plans, if any, he has for strong controls in this regard; and if he will make a statement on the matter. [23831/98]

Minister for Health and Children (Mr. Cowen)

I propose to answer Questions Nos. 42 and 70 together.

First, in relation to anti-acne preparations, there is a wide range of products available in Ireland indicated for the treatment of acne in its varying conditions, ranging from mild and moderate acne to severe and nodulocystic acne. Some of these products, in particular those for mild acne, may be purchased through pharmacies without prescription, whilst others, such as Roaccutane, may only be supplied on the basis of a doctor's prescription.

It is important to stress that all medicinal products placed on the market in Ireland must be the subject of a product authorisation issued by the Irish Medicines Board and that the board will only issue such an authorisation after it has carried out detailed assessments to establish the safety, quality and efficacy of the product. In addition, the board may impose restrictions on the sale or supply of a product depending on the risk-benefits ratios associated with it. The board must also approve the prescribing data and patient information leaflets including any warnings or precautions that it may consider necessary.

In relation to Roaccutane, I am aware of recent reports suggesting possible linkages between this product and depression, including suicidal tendencies. Roaccutane, isotretinoin, is a vitamin A derivative used in the treatment of acne. In Ireland, it is authorised by the Irish Medicines Board for the treatment of severe acne, unresponsive to other treatments, and its availability is limited in that it must be prescribed and its use monitored by a specialist dermatologist.

The Irish Medicines Board has, on an ongoing basis, been actively monitoring data on Roaccutane which it has reviewed both internally with experts and with the other European regulatory agencies. In addition, the board has also recently reviewed the terms of the product authorisation with the company. As a result of this, revised wording for inclusion in the prescribing information for the product, outlining the current position regarding its use and warnings related to the possible development of psychiatric reactions, were agreed. The warnings refer to possible side effects including depression, psychotic symptoms and of rare reports of suicide associated with Roaccutane. The revised warnings have been incorporated into the authorisation documents for the product and the company has circularised all physicians and pharmacists outlining the new warnings regarding the use of Roaccutane.

In accordance with its policy, the Irish Medicines Board continues on an ongoing basis to monitor reports of adverse reactions to all medicines, including Roaccutane. At the same time, it is important in using any medicine that patients should read carefully the patient information leaflet and follow any instructions provided with the medication and consult with their physicians in relation to any problems, side effects or uncertainties they may encounter.